GPB Scientific Announces Additional Growth Financing to Support Commercialization of Curate Cell Processing System for Next-Generation Cell & Gene…

- Syndicate includes existing investors Vensana Capital and Amgen Ventures joined by new healthcare investor

- Amgen Vice President of Research Philip Tagari, joins companys board of directors

CARLSBAD, Calif.--(BUSINESS WIRE)-- GPB Scientific, Inc., a developer of transformative cell processing technology for next generation cell and gene therapies, today announced raising an additional $18 million in capital as part of a previously announced financing, including commitments from existing investors Vensana Capital and Amgen Ventures, and from a new undisclosed healthcare investor. This financing will support expanded placements of GPBs Curate Cell Processing System into partner facilities to enable optimized development and manufacturing in CAR-T and TCR programs, as well as development of the platforms utility in additional types of cell and gene therapy applications.

Conventional bioprocessing solutions for cell and gene therapies are challenged by cost, turnaround time, and scalability as well as suboptimal clinical performance characterized by limitations on cell therapy persistence, potency, adverse events, and applicability to various tumor types. The Curate system utilizes GPBs proprietary Deterministic Cell Separation technology to deliver unmatched recovery, purity, and cell health impacting each of these challenges in bioprocessing for cell and gene therapies. In its first application, the Curate system has been optimized for T-cell isolation and associated downstream handling activities such as washing, concentrating, and exchanges in centralized and decentralized workflows. Additional applications will include optimization for stem cells and other cell types. Early data on GPB Scientifics Deterministic Cell Separation process confirm substantial improvements in cost, target cell harvest time, and cell quality which enable the pursuit of advanced objectives across operational, clinical, and business-related areas of interest for therapy developers.

In parallel with GPBs progress on the development of the Curate platform, Phillip Tagari, Amgens Vice President of Research, has joined GPB Scientifics Board of Directors. He commented, "The Curate system is poised to be transformative for cell and gene therapies. As the industry works to implement reliable, efficient, and cost-effective systems for the global deployment of these breakthrough medical treatments, GPB has devised an elegant yet powerful solution for cell separation, washing and concentration. The broad potential of this innovation aligns with Amgen's mission to partner with innovators in the fight against serious illness."

"In order for cell and gene therapies to achieve their full potential, promising outcomes in hematological cancers that supported recent FDA approvals must be followed by improvements in manufacturing cost reductions, scalability and turnaround time for patients. Moreover, we hope to see continued advances in clinical impact against solid tumors and other indications for cell therapies. These advances will require creativity and execution from the drug developers, but in almost every case, can be aided by bioprocessing enhancements that yield more and healthier cells that are collected more efficiently, said Justin Klein, M.D., co-founder and managing partner at Vensana Capital. "In a field where the process is the product, we believe GPB Scientifics Curate Cell Processing System can confer a significant competitive advantage for cell and gene therapy companies and a much needed solution to scaling production to meet global demand."

"We are pleased to see that our progress over the past year has been recognized by our existing partners and by new, important sponsors that share our vision for advancing therapies, said Mike Grisham, CEO of GPB Scientific. Our groundbreaking cell processing capabilities will enable next-generation medicines that are more consistently produced, at lower cost, for more patients and for additional conditions. We are proud to expand our efforts with this increased funding to deliver on our promise and to play our part in the enabling the development of new treatments for intractable disease.

About GBP Scientific

GPB Scientific is a pioneering biomedical company realizing the promise of its Curate Cell Processing System. The Curate solution applies Deterministic Cell Separation (DCS) technology, through a benchtop system and single-use cartridges that are currently optimized for T-cells. Designed with both manufacturing and clinical potential at the forefront, Curate delivers the scale and performance required to advance CAR-T and TCR applications beyond their limitations today. GPB works with leading biopharma and biotech companies, cancer centers, research institutes, and universities to advance the technology within and beyond this space, with future releases targeting additional cell types, use cases, disease states, and workflow paradigms.

Learn more at http://www.gpbscientific.com or contact inquiries@gpbscientific.com

About Vensana Capital

Vensana Capital is a venture capital and growth equity investment firm dedicated to partnering with entrepreneurs who seek to transform healthcare with breakthrough innovations in medical technology. Launched in 2019, Vensana is actively investing in late development and commercial stage companies across the medtech sector, including medical devices, diagnostics, drug delivery, digital health, and tech-enabled services. Vensanas investment team has a history of successfully partnering with management teams behind industry-leading companies including Cameron Health, CardiAQ, Cartiva, CV Ingenuity, Epix Therapeutics, Inari Medical, Intact Vascular, Lutonix, Neuwave Medical, Sequent Medical, Topera, Ulthera, Veran Medical Technologies, and Vertiflex. Learn more at http://www.vensanacap.com

About Amgen Ventures

Established in 2004 as Amgen's corporate venture capital arm, Amgen Ventures identifies and invests in emerging companies and technologies to advance promising new medicines and solutions to healthcare's biggest challenges. Amgen Ventures has committed $625M to invest in biotechs focused on human therapeutics and drug discovery as well as MedTech, such as digital health platforms, data analytics, and value-based approaches.

Learn more at http://www.amgenbd.com

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GPB Scientific Announces Additional Growth Financing to Support Commercialization of Curate Cell Processing System for Next-Generation Cell & Gene...

TScan Therapeutics Adds to Executive Leadership Team and Board of Directors – BioSpace

Bill Desmarais, Ph.D., MBA, named Chief Business Officer, bringing more than 20 years of business development and partnering experience

Oncology drug development veteran Gabriela Gruia, M.D., appointed to Board of Directors

Timothy Barberich named Chair of Board of Directors

WALTHAM, Mass.--(BUSINESS WIRE)-- TScan Therapeutics, Inc. (TScan), a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced the appointments of Bill Desmarais, Ph.D., MBA, as Chief Business Officer, and Gabriela Gruia, M.D., to its Board of Directors. Dr. Desmarais brings more than 20 years of business development, partnering, and research experience to TScan, including his most recent role as Vice President of Business Development of Momenta Pharmaceuticals, where he spearheaded the Companys partnering strategy that led to Momentas $6.5 billion acquisition by Johnson & Johnson. Dr. Gruia is a seasoned oncology drug development executive with more than 25 years of global regulatory and research experience, including at Novartis as Global Head of Drug Regulatory, Oncology. The Company also named Timothy Barberich, the founder and former Chair and CEO of Sepracor Inc. and member of TScans Board, as Chair of the Board of Directors.

We are thrilled to welcome Bill and Gabriela to the TScan team as we continue to advance our pipeline of TCR-T therapies to the clinic for cancers with significant unmet need, said David Southwell, Chief Executive Officer and President at TScan. Bills proven track record of securing key corporate partnerships and licensing collaborations throughout his 20-year career at leading biopharmaceutical companies will be invaluable to TScan as we look to maximize the full potential of our discovery platform in oncology and in other therapeutic areas, including autoimmune disorders and infectious diseases. Gabriela is an accomplished oncology drug developer that spearheaded the worldwide regulatory approval of 12 novel therapeutics throughout her 16-year career at Novartis. We look forward to working with her on our Board. Additionally, we are pleased to have Tim Barberichs leadership as Chair of TScans Board as we continue to progress our programs.

I look forward to leading TScans efforts to work with strategic partners to further unlock the potential of our target discovery platform across the domains of oncology, autoimmune and infectious disease, said Dr. Desmarais.

TScan has a strong commitment to improving the lives of cancer patients. I am honored to join TScans Board of Directors and believe my oncology drug development and regulatory expertise will be beneficial in helping advance TScans pipeline of TCR-T therapies through the clinic, said Dr. Gruia.

Prior to joining TScan, Dr. Desmarais served as Vice President of Business Development of Momenta Pharmaceuticals. Before Momenta, Dr. Desmarais spent 11 years in roles of increasing responsibility within business development and research and development at Eli Lilly & Co. At Lilly, Dr. Desmarais oversaw regional licensing, promotion and distribution, and co-marketing deals in South Korea, Latin America, Russia, and Japan, assisted in drug repositioning efforts and academic collaborations, and managed the scientific pre-due diligence process for potential partnering opportunities. He received his Ph.D. in Biophysics and Structural Biology from Brandeis University, an MBA from Massachusetts Institute of Technology and a B.S. in Cell and Developmental Biology from Purdue University.

Dr. Gruia most recently served as Chief Development Officer at Ichnos Sciences, where she oversaw regulatory sciences, clinical operations, drug safety, clinical pharmacology, biostatistics and clinical outsourcing. Prior to joining Ichnos, Dr. Gruia spent 16 years at Novartis where she served in several senior roles of increasing responsibility, including Senior Vice President and Global Head of Drug Regulatory Affairs Oncology and Head of Medical Writing and Submissions. At Novartis, Dr. Gruia led the world class oncology regulatory affairs organization of approximately 120 associates and managed all regulatory activities in close partnership with research collaborators, preclinical development, the development organization and senior management. Previously, Dr. Gruia held oncology research and development roles at Pfizer, Pharmacia, Aventis and Rhone Poulenc Rorer. Dr. Gruia received her doctorate in medicine from Bucharest Medical School in Romania and a Masters in Breast Pathology and Mammography from Rene Huguenin/Curie Institute Cancer Center in Paris, France. She received her training in oncology and hematology from Rene Descartes University in Paris, France.

Mr. Barberich is founder and former Chair and CEO of Sepracor Inc., a research-based pharmaceutical company which was acquired by Dainippon Sumitomo Pharma Co., Ltd. in 2009 and is now known as Sunovion Pharmaceuticals. Mr. Barberich served as CEO of Sepracor from 1984 to 2007 and as Chair of the Board from 1990 to 2009. Prior to founding Sepracor, Mr. Barberich spent 10 years as a senior executive at Millipore Corporation. He holds a B.S. in chemistry from Kings College.

About TScan Therapeutics

TScan is a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer. The companys lead liquid tumor TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual leukemia and prevent relapse after hematopoietic stem cell transplantation. The company is also developing multiplexed TCR-T therapy candidates for the treatment of various solid tumors.

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TScan Therapeutics Adds to Executive Leadership Team and Board of Directors - BioSpace

Bone Therapeutics Provides First Quarter 2021 Business Update – GlobeNewswire

REGULATED INFORMATION

Strong clinical progress especially in JTA-004 Phase III study thanks to high patient compliance and retention

Process development partnership and appointment of cell therapy expert Anthony Ting as CSO to further strengthen product pipeline

Gosselies, Belgium, 26May 2021, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces its business update for the first quarter, ended 31 March 2021.

Bone Therapeutics has continued the strong momentum into 2021, said Miguel Forte, MD, PhD, CEO of Bone Therapeutics. Bone Therapeutics mid-late stage clinical programs continue to advance largely on schedule, including the Phase IIb trial of the allogenic cell therapy platform ALLOB in difficult-to-heal tibial fractures and the Phase III trial of the enhanced viscosupplement JTA-004 in knee osteoarthritic pain. Alongside this, Bone Therapeutics has strengthened its manufacturing and R&D capabilities by signing a process development partnership with Rigenerand. It has also appointed the industry veteran Tony Ting as our new Chief Scientific Officer. Building on these achievements, Bone Therapeutics will be able to continue significant clinical and commercial advancements as we move towards the topline data of our JTA-004 Phase III study; a potential key inflection point for Bone Therapeutics.

Operational highlights

Financial highlights

Outlook for the remainder of 2021

(1) Unaudited number

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in Phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SA Miguel Forte, MD, PhD, Chief Executive Officer Jean-Luc Vandebroek, Chief Financial Officer Tel: +32 (0)71 12 10 00 investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries: Bepublic Catherine Haquenne Tel: +32 (0)497 75 63 56 catherine@bepublic.be

International Media Enquiries: Image Box Communications Neil Hunter / Michelle Boxall Tel: +44 (0)20 8943 4685 neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries: NewCap Investor Relations & Financial Communications Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouill Tel: +33 (0)1 44 71 94 94 bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics Provides First Quarter 2021 Business Update - GlobeNewswire

Merakris Therapeutics, Inc. Announces FDA Clearance for – GlobeNewswire

RESEARCH TRIANGLE PARK, N.C., May 25, 2021 (GLOBE NEWSWIRE) -- Merakris Therapeutics, Inc. (Merakris) announced that it has received U.S. Food and Drug Administration (FDA) clearance for a Phase II clinical trial involving its investigational new drug (IND), Dermacyte Amniotic Wound Care Liquid. The study will address the frequency of administration, safety and efficacy of Dermacyte Liquid in treating non-healing venous stasis ulcers (VSUs).

Merakris is a Research Triangle Park-based biotechnology business dedicated to the research, development and marketing of regenerative healthcare products.

The company initially met with the FDA in 2020 to discuss the clinical trial and IND filing, according to CEO Chris Broderick. He said the team at Merakris which includes experts in regulatory affairs, Good Clinical Practices, clinical data management, and clinical trial design and oversight will manage the study. It will work with a Good Manufacturing Practice (GMP) laboratory partner to ensure that the investigational product is manufactured in accordance with all FDA requirements.

We are excited about the potential benefits Dermacyte Liquid offers to patients in terms of healing difficult-to-treat venous leg ulcers caused by venous reflux disease, Broderick stated. And we look forward to more closely assessing the safety and efficacy of this product in our upcoming clinical trial.

Dermacyte Amniotic Wound Care Liquid is an acellular, sterile-filtered human amniotic fluid allograft. Merakris lead scientist has shown that the product stimulates skin cell migration and activates the gene expression pathways required to promote wound healing. If approved, it will be the first subcutaneous (below the skin) biologic indicated for VSUs.

The global market for the treatment of venous leg ulcers was valued at $2.95 billion in 2018 and is forecasted to reach $4.84 billion by 2026, Merakris reported. An estimated 500,000-600,000 people suffer from VSUs in the U.S. alone. Topical cellular/biological skin graft substitutes are often used as advanced skin graft substitutes to treat VSUs.

Dermacyte Liquid contains the natural biomolecules present in amniotic tissues and fluids. In a discovery-based translational research project, the company has isolated various components of Dermacyte Liquid and is studying how it affects the stages of wound healing. The data from the project suggest that these components may allow us to usher in a new era of precision wound healing, based on a patients personal wound profile, Broderick pointed out.

He said the company has filed patents covering Dermacyte Liquid and its unique mode of action and plans to conduct additional pre-clinical and clinical studies to evaluate the products safety and efficacy in cutaneous wound healing.

MerakrisTherapeutics, founded in 2016, is pioneering the use of commercially scalable stem cell-derived biotherapeutic technologies to promote the healing of damaged tissue. Its mission is to improve global patient care and outcomes through regenerative biotechnologies. The companys products include:

The company also is investigating other novel biotechnology solutions to promote wound healing and skin rejuvenation.

About the Dermacyte Liquid Phase II Clinical Trial Dermacyte Liquid will be evaluated in a Phase II clinical trial entitled, A Two-Part, Randomized Study of Dermacyte Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers. The clinical trial has been designed to include an initial open-label study group (Part 1) followed by a randomized, double-blind, placebo-controlled study group (Part 2) in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of the biological drug product.

The run-in phase of the study (Part 1) will enroll 10 eligible subjects. In Part 1, patients will be randomized 1:1 to receive active Dermacyte once weekly or once every two weeks with standard of care. The data from Part 1 will be reviewed to determine the administration frequency of the study product (once weekly or once every two weeks) in Part 2 of the Study.

In Part 2, approximately 30 subjects will be randomized 1:1 to receive Dermacyte Liquid or placebo with standard of care. Subjects will be followed for 12 weeks.

Subjects will receive localized subcutaneous injection of Dermacyte Liquid or placebo into and/or around the wound bed during clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area (L X W) from Baseline. Overall change in patient reported pain scores from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Merakris management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole.

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Merakris Therapeutics, Inc. Announces FDA Clearance for - GlobeNewswire

Stem Cell Manufacturing Market 2021 | Research With Size, Growth, Manufacturers, Key Segment, Analysis, Development Status, Segments and 2027…

Global Stem Cell Manufacturing Market Report from DBMR highlights deep analysis on market characteristics, sizing, estimates and growth by segmentation, regional breakdowns& country along with competitive landscape, players market shares, and strategies that are key in the market. The exploration provides a 360 view and insights, highlighting major outcomes of the industry. These insights help the business decision-makers to formulate better business plans and make informed decisions to improved profitability. In addition, the study helps venture or private players in understanding the companies in more detail to make better informed decisions.

Stem cell manufacturing is forecasted to grow at CAGR of 6.42% to an anticipated value of USD 18.59 billion by 2027 with factors like rising awareness towards diseases like cancer, degenerative disorders and hematopoietic disorders is driving the growth of the market in the forecast period of 2020-2027.

Download Exclusive Sample (350 Pages PDF) Report: To Know the Impact of COVID-19 on thisIndustry@https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-stem-cell-manufacturing-market&AB

Stem cell manufacturing has shown an exceptional penetration in North America due to increasing research in stem cell. Increasing research and development activities in biotechnology and pharmaceutical sector is creating opportunity for the stem cell manufacturing market.

The Global Stem Cell Manufacturing Market 2020 research provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Global Stem Cell Manufacturing Market Share analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed.

Global Stem Cell Manufacturing Market Segematation By Product (Stem Cell Line, Instruments, Culture Media, Consumables), Application (Research Applications, Clinical Applications, Cell and Tissue Banking), End Users (Hospitals and Surgical Centers, Pharmaceutical and Biotechnology Companies, Clinics, Community Healthcare, Others)

List of TOP KEY PLAYERS in Stem Cell Manufacturing Market Report are

Thermo Fisher Scientific Merck KGaA BD JCR Pharmaceuticals Co., Ltd Organogenesis Inc Osiris Vericel Corporation AbbVie Inc AM-Pharma B.V ANTEROGEN.CO.,LTD Astellas Pharma Inc Bristol-Myers Squibb Company FUJIFILM Cellular Dynamics, Inc RHEACELL GmbH & Co. KG Takeda Pharmaceutical Company Limited Teva Pharmaceutical Industries Ltd ViaCyte,Inc VistaGen Therapeutics Inc GlaxoSmithKline plc ..

Complete Report is Available (Including Full TOC, List of Tables & Figures, Graphs, and Chart)@https://www.databridgemarketresearch.com/toc/?dbmr=global-stem-cell-manufacturing-market&AB

The report can help to understand the market and strategize for business expansion accordingly. In the strategy analysis, it gives insights from marketing channel and market positioning to potential growth strategies, providing in-depth analysis for new entrants or exists competitors in the Stem Cell Manufacturing industry. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins. For each manufacturer covered, this report analyzes their Stem Cell Manufacturing manufacturing sites, capacity, production, ex-factory price, revenue and market share in global market.

The Global Stem Cell Manufacturing Market Trends, development and marketing channels are analysed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered.

Global Stem Cell Manufacturing Market Scope and Market Size

Stem cell manufacturing market is segmented on the basis of product, application and end users. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Based on product, the stem cell manufacturing market is segmented into stem cell lines, instruments, culture media and consumables. Stem cell lines are further segmented into induced pluripotent stem cells, embryonic stem cells, multipotent adult progenitor stem cells, mesenchymal stem cells, hematopoietic stem cells, neural stem cells. Instrument is further segmented into bioreactors and incubators, cell sorters and other instruments.

On the basis of application, the stem cell manufacturing market is segmented into research applications, clinical applications and cell and tissue banking. Research applications are further segmented into drug discovery and development and life science research. Clinical applications are further segmented into allogenic stem cell and autologous stem cell therapy.

On the basis of end users, the stem cell manufacturing market is segmented into hospitals and surgical centers, pharmaceutical and biotechnology companies, research institutes and academic institutes, community healthcare, cell banks and tissue banks and others.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Stem cell manufacturing market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for stem cell manufacturing market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the stem cell manufacturing market. The data is available for historic period 2010 to 2018.

The Global Stem Cell Manufacturing Market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of stem cell manufacturing market for global, Europe, North America, Asia Pacific and South America.

Key Insights in the report:

Historical and current market size and projection up to 2025

Market trends impacting the growth of the global taste modulators market

Analyze and forecast the taste modulators market on the basis of, application and type.

Trends of key regional and country-level markets for processes, derivative, and application Company profiling of key players which includes business operations, product and services, geographic presence, recent developments and key financial analysis

For More Information or Query or Customization Before Buying, Visit @https://databridgemarketresearch.com/inquire-before-buying/?dbmr=global-stem-cell-manufacturing-market&AB

Opportunities in the market

To describe and forecast the market, in terms of value, for various segments, by region North America, Europe, Asia Pacific (APAC), and Rest of the World (RoW)

The key findings and recommendations highlight crucial progressive industry trends in the Stem Cell manufacturing Market, thereby allowing players to develop effective long term strategies

To strategically profile key players and comprehensively analyze their market position in terms of ranking and core competencies, and detail the competitive landscape for market leaders Extensive analysis of the key segments of the industry helps in understanding the trends in types of point of care test across Europe.

To get a comprehensive overview of the Stem Cell manufacturing market.

With tables and figures helping analyses worldwide Global Stem Cell Manufacturing Market Forecast this research provides key statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market. There are 15 Chapters to display the Stem Cell Manufacturing market.

Chapter 1, About Executive Summary to describe Definition, Specifications and Classification of Stem Cell Manufacturing market, By Product Type, by application, by end users and regions.

Chapter 2, objective of the study.

Chapter 3, to display Research methodology and techniques.

Chapter 4 and 5, to show the Stem Cell Manufacturing Market Analysis, segmentation analysis, characteristics;

Chapter 6 and 7, to show Five forces (bargaining Power of buyers/suppliers), Threats to new entrants and market condition;

Chapter 8 and 9, to show analysis by regional segmentation[North America, Europe, Asia-Pacific etc ], comparison, leading countries and opportunities; Regional Marketing Type Analysis, Supply Chain Analysis

Chapter 10, to identify major decision framework accumulated through Industry experts and strategic decision makers;

Chapter 11 and 12, Stem Cell Manufacturing Market Trend Analysis, Drivers, Challenges by consumer behavior, Marketing Channels

Chapter 13 and 14, about vendor landscape (classification and Market Ranking)

Chapter 15, deals with Stem Cell Manufacturing Market sales channel, distributors, Research Findings and Conclusion, appendix and data source.

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia or Oceania [Australia and New Zealand]

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Stem Cell Manufacturing Market 2021 | Research With Size, Growth, Manufacturers, Key Segment, Analysis, Development Status, Segments and 2027...

Tissue regeneration: Reserve or reverse? – Science Magazine

A cross section of mouse small intestine, showing intestinal crypts and villi, is visualized with immunofluorescence microscopy (nuclei in red, and F-actin, which marks the cytoskeleton, in blue). Intestinal stem cells reside at the base of crypts, where they maintain cell turnover.

Tissues with high intrinsic turnover, such as the skin and intestinal lining, rely on resident stem cells, which generate all native cell types. Intestinal stem cells (ISCs) are highly sensitive to damage, although they recover quickly. It is unclear whether this recovery (i.e., regeneration) occurs from less sensitive pools of reserve stem cells (1) or whether ISC progeny undergo reverse differentiation into stem cells (2). Recent studies in diverse organs highlight that dedifferentiation of specified cell types is a pervasive and dominant means for tissue regeneration. The findings have broad implications because all tissues experience some cell attrition over a lifetime, and knowing how tissues replenish those losses may help in preventing or treating organ failure. Moreover, it remains unclear whether incomplete differentiation, a common feature of cancer, reflects normal tissue plasticity, and it is unclear whether stem cells that arise by dedifferentiation may spawn cancers.

ISCs expressing leucine-rich repeatcontaining G proteincoupled receptor 5 (Lgr5) lie at the bottom of small bowel crypts (3). In the course of homeostatic tissue turnover, their immediate progeny adopt alternative enterocyte or secretory fates, then fill the crypts with replicating progenitors that migrate away from ISCs. Cell division ceases at the crypt tops, where postmitotic cells begin a 3- to 5-day journey along intestinal villi. When ISCs sustain irreparable damage, some source in the crypt must regenerate new ISCs. Other adult epitheliasuch as airways, prostate, and liverare organized differently from the intestine and from each other (see the figure). These epithelia also restore cells lost by damage or attrition, even though at rest they turn over at least a hundred times more slowly than the intestinal lining.

Airway epithelial structure varies from trachea to small bronchioles, and distinct progenitors in different segments produce assorted secretory and ciliated cell types. In the lining of human and mouse upper airways, flat basal cells lie beneath a layer of columnar differentiated cells and adjacent to submucosal myoepithelial glands. Stem cell activity in normal tissue turnover maps to a subpopulation of keratin 5 (Krt5)expressing basal cells (4). The trachea and bronchi are vulnerable to diverse injuries, including targeted destruction of Krt5+ stem cells and pervasive mucosal damage from noxious inhalants or viruses.

Adult human and mouse prostate glands also contain columnar luminal and flat KRT5+ basal cells. Distinct unipotent progenitors maintain both populations, and castration induces massive luminal cell loss. Androgen reexposure restores prostate mass within weeks, which implies the presence of castration-resistant progenitors. However, an unequivocal stem cell pool has not been identified. The liver also has notable regenerative abilities after chemical or surgical injury. The emerging consensus is that this organ lacks a dedicated stem cell compartment and recovers from damage through dedifferentiation of mature hepatocytes and biliary cells (5, 6).

Stem cell activity in vivo is demonstrated most persuasively by introducing into a tissue a permanent color or fluorescent label whose expression depends on Cre recombinasemediated excision of a STOP cassette. When Cre activity is restricted to stem cells, all the progeny of those cells exclusively carry the label. ISCs and tracheal stem cells were thus identified because targeted Cre activity in LGR5+ or KRT5+ mouse cells labeled the respective full lineages (3, 4). Investigation of tissue regeneration requires ablation of a stem cell compartment, followed by tracking of the restored ability to produce sufficient numbers of all native stem cell progeny. The canon of tissue repair rests heavily on such lineage-tracing experiments, but one limitation is that Cre recombinase is not often confined to a single defined cell type. This challenge lies at the heart of competing models for tissue recovery after lethal cell injuries.

Dividing cells take up labels such as [3H]thymidine or fluorescent histone 2B and shed these labels as they replicate further or their daughters die. In the intestine, however, rare cells located near the fourth tier from the crypt base retain [3H]thymidine for weeks. Given once-popular ideas that stem cells must be few in number and retain one immortal DNA strand when they replicate, +4 label-retaining cells (LRCs) were described as ISCs. In support of that idea, lineage tracing from Bmi1, a locus thought to be restricted to nonreplicating +4 LRCs, elicited an ISC-like response in vivo (7).

Physiologic cell turnover and recovery from injury occur from different cellular sources in diverse epithelia (intestine, upper airway, and prostate gland). Homeostatic turnover is driven by the stem cell pool, and tissue restoration from injury occurs through transient expansion and dedifferentiation of specified mature cells.

To reconcile the evidence for ISC properties in both LGR5+ crypt base columnar cells (CBCs) and +4 LRCs, researchers postulated that abundant CBCs serve as frontline ISCs, whereas the smaller +4 LRC population contains dedicated reserves. Indeed, intestinal turnover is unperturbed when LGR5+ CBCs are ablated because other crypt cells' progeny continue to repopulate villi and an LGR5+ ISC compartment is soon restored (1). Multiple candidate markers of +4 LRCs that regenerate ISCs after injury have been proposed (8). Although these cells are too few to explain the typical scale and speed of ISC restoration, the prospect of two stem cell pools carried the additional allure of a sound adaptive strategy in a tissue that requires continuous self-renewal.

ISC differentiation is, however, not strictly unidirectional. Cre expression in absorptive or secretory cell types tags those cells selectively, but upon ablation of LGR5+ CBCs, the label appears throughout (9). These observations imply that differentiated daughter cells have reverted into ISCs. Moreover, Bmi1 expression was found to mark differentiated crypt endocrine cells (10), and putative +4 markers are expressed in many crypt cells including LGR5+ CBCs. Accordingly, when Cre is expressed from these loci, the traced lineage might simply reflect CBC activity in resting animals and reverse differentiation of crypt cells after ISC ablation. But is dedifferentiation a rare and physiologically inconsequential event or the predominant mode of stem cell recovery? Dedifferentiation may obviate the need to invoke a dedicated reserve population, or it is possible that ISC recovery may reflect both dedifferentiation and contributions from a reserve stem cell population.

To investigate these issues, researchers activated a fluorescent label in LGR5+ CBCs and waited for this label to pass into progeny cells before ablating CBCs (11). Thus, only the CBCs that recover by dedifferentiation should be labeled, and any cells arising from reserve ISCs should not. Nearly every restored crypt and CBC was fluorescent, with substantial contributions from both enterocytes and secretory cells (11). Cells captured early in the restorative process coexpressed mature-cell and ISC genes, which is compatible with recovery by dedifferentiation. Another study found that damaged ISCs are reconstituted wholly by the progeny of LGR5+ CBCs (8). Thus, dedifferentiation would seem to be the principal mode of ISC regeneration, and prior conclusions about +4 ISCs likely reflect unselective Cre expression.

Different tissues might deploy distinct regenerative strategies, and recent studies in mouse airway, prostate, intestinal, and liver epithelia provide insightful lessons. After ablation of KRT5+ airway stem cells, specified secretory and club cell precursors were found to undergo clonal multilineage expansion and accounted for up to 10% of restored KRT5+ cells in vivo (12). Chemical or viral damage was subsequently reported to induce migration and dedifferentiation of submucosal gland myoepithelial cells into the basal layer to reconstitute the surface lining, including KRT5+ stem cells (13). Thus, dedifferentiation into native stem cells occurs upon injury to both airway and intestinal linings in mice.

Single-cell RNA sequencing (scRNA-seq) analysis of mouse prostate glands recently revealed distinct gene expression profiles in 3% of luminal cells, which are more clonogenic than others, express putative stem cell markers, and hence qualify as a pool enriched for native stem-like cells (14). After androgen reexposure following castration, however, the scale and distribution of cell replication and the location of restored clones were incompatible with an origin wholly within that small pool. Rather, the principal source of gland reconstitution in vivo, including new KRT5+ basal cells, was the dominant population of differentiated luminal cells (14). These observations parallel those in the liver, where recovery of organ mass after tissue injury occurs by renewed proliferation of mature resting hepatocytes (5), abetted by expansion of bile duct cells that transdifferentiate into hepatocytes (6). Cell plasticity is thus widespread, whether tissues have or lack native stem cell compartments.

Reverse differentiation in the intestine, airways, and prostate gland was generally observed after near-total elimination of resident stem or luminal cells, an extreme and artificial condition. However, several observations suggest that this dedifferentiation reflects a physiologic process designed to maintain a proper cell census. Contact with a single KRT5+ airway stem cell prevents secretory and club cell dedifferentiation in vitro (12), and tracheal submucosal glands exhibit limited stem cell activity even in the absence of injury (13). Live imaging of intestinal crypts reveals continuous and stochastic exit from and reentry into the ISC compartment (15), implying that barriers for differentiation or dedifferentiation are inherently low. However, the primary purpose of dedifferentiating airway, intestinal, liver, and prostate cells is not to enable tissue recovery. Therefore, they should be regarded as facultative stem cells; that is, they have other physiologic functions and realize a latent stem cell capacity only under duress.

This distinction from reserve stem cells is not merely semantic. Emphasis in regenerative therapy research belongs on any cell population with restorative potential; in vivo findings now direct attention away from putative reserve cells and toward dedifferentiation as a common means for tissue recovery. The absence of dedicated reserves and the inherent cellular ability to toggle between stem and differentiated states also inform cancer biology. Because mutations realize oncogenic potential only in longlived cells, both frontline and reserve stem cells represent candidate sources of cancer, in contrast to differentiated cells, which are generally short-lived. However, oncogenic mutations that arise in differentiated cells could become fixed upon dedifferentiation, thus enabling tumor development.

Notably, stem cell properties and interconversion with their progeny are not stereotypic. ISCs divide daily into two identical daughters, whereas hematopoietic stem cell replication is infrequent and asymmetric. Severe loss of blood stem cells does not elicit substantial dedifferentiation and is rescued only by adoptive stem cell transfer. Immature secretory precursors dedifferentiate more readily than terminally mature airway cells (12), whereas fully differentiated cells fuel liver and prostate regeneration. Cell plasticity in each case is determined by local signals. Unknown factors from KRT5+ tracheal stem cells, for example, suppress secretory cell dedifferentiation (12), and specific factors secreted from the prostate mesenchyme stimulate luminal cell dedifferentiation (14). The intestinal mesenchyme probably senses ISC attrition to trigger tissue recovery, but the spatial and molecular determinants remain unknown. Outstanding challenges are to identify the signaling pathways that ensure a stable cell census and to harness diverse regenerative responses to ameliorate acute tissue injuries or prevent organ failure. Knowing the cellular basis for stem cell recovery in different contexts brings us closer to those goals.

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Tissue regeneration: Reserve or reverse? - Science Magazine

Global Scaffold Technology Market Is Expected to Reach USD 2.16 billion by 2028 : Fior Markets – GlobeNewswire

February 18, 2021 13:00 ET | Source: Fior Markets

Newark, NJ, Feb. 18, 2021 (GLOBE NEWSWIRE) -- As per the report published by Fior Markets, theglobal scaffold technology market is expected to grow from USD 1.05 billion in 2020 and to reach USD 2.16 billion by 2028, growing at a CAGR of 9.45% during the forecast period 2021-2028.

The driving factors to the growth of the scaffold technology market are an increase in the requirement of organ transplantations and reconstruction procedures for the body across the globe. Scaffold technology is extensively utilized in order to imitate the construction of tissues. It is done in order to form a three-dimensional structure that enhances transplantation methods, resulting in an increase in the growth of the market. Scaffold technology plays an essential part in the regeneration and restoration of infected tissues in tissue engineering. Scaffold technology has various benefits in three-dimensional printing like the inclusion of growth factors, porosities, co-culture of multiple cells, and construction of composite geometries.

Tissue culture is depicted in a 3D arrangement with the help of scaffold technology. The technology is broadly used to provide cultural assays in three-dimension. Scaffold technology is a department of Tissue Engineering that overcomes the limitations made by two-dimensional cell culture. The three-dimensional cultural assays include cell to matrix interactions, cell migration assays, and cell to cell interactions. Scaffold technology mimics primary cells to use different tissues. It is done in order to mimic defective tissues from the scaffold biomaterials that are deeply porous. It works under cell biology that regulates three-dimensional cell structure.

An increase in the utilization of biomaterials that involves composites and polymers leads to the increase of fabrication of scaffold. It propels the market by encouraging the extensive use of scaffold technology in tissue engineering. Technological innovations and advancements related to reconstructive operational methods promote enhanced incorporation of scaffold technology. This promotes the usage of scaffold technology in the reconstructive processes. Moreover, continuous research and development programs in order to produce three-dimensional substrates result in an increased application of the technology in drug delivery. Also, inclination towards three-dimensional cell tissue culture from two-dimensional systems is expected to accelerate the growth of the market over the forecast period.

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Key players operating in the global scaffold technology market include REPROCELL Inc., Tecan Trading AG, Molecular Matrix Inc., Xanofi, 3D Biotek LLC, Becton, Dickinson and Company, Thermo Fisher Scientific, Inc. and Merck KGaA. To gain a significant market share in the global scaffold technology market, the key players are now focusing on adopting strategies such as product innovations, mergers & acquisitions, recent developments, joint ventures, collaborations, and partnerships.

The nanofiber-based scaffolds segment is expected to show the highest share over the forecast periodThe type segment includes nanofiber based scaffolds, micropatterned surface microplates, polymeric scaffolds and hydrogels. The nanofiber-based scaffolds segment is expected to show the highest share in the global scaffold technology market over the forecast period. The nanofiber-based scaffolds have threadlike compositions that consist of pores. It is created with the help of the electro spinning method to promote the development of synthetic functional tissues in tissue engineering. Such synthetic tissues follow the typical extracellular pattern in tissues. It is beneficial in improving tissue engineering with the help of extracellular model of the tissue.

The stem cell therapy, regenerative medicine, and tissue engineering segment had the highest share of 56.04% in 2020 The application segment includes drug discovery, stem cell therapy, regenerative medicine, & tissue engineering. The stem cell therapy, regenerative medicine, and tissue engineering segment had the highest share of 56.04% in 2020 in the global scaffold technology market. The factors that contributed to the growth of the market are an extensive utilization of scaffold technology in colorectal surgeries, periodontology, abdominal wall repair, soft tissue tumor repair, aesthetic surgeries and wound healing. In order to improve the regeneration system, the blend of tissue repair scaffold along with antimicrobial agent is employed. Thus, it is anticipated to enhance reconstructive methods that include a huge probability of failure of reconstructed tissue. Hence, tissue-engineering in a controlled structure is a significant factor in the growth.

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Regional Segment Analysis of The Scaffold Technology Market

On the basis of geography, the global scaffold technology market is classified into North America, Europe, South America, Asia Pacific, and Middle East and Africa. North America had the largest share of 23.86% in 2020. The factors that contributed to the growth of the region are an increase in the investments in order to extend the applicability of scaffold technology, advanced healthcare structure as well as a growth in stem cell research along with regenerative medicine. Increasing investments by the prominent market players in order to increase the utilization of regenerative medicine and three-dimensional constructs in numerous applications has resulted in the growth of the market.

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About the report: The global scaffold technology market is analyzed on the basis of value (USD billion). All the segments have been analyzed on global, regional and country basis. The study includes an analysis of more than 30 countries for each segment. The report offers in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insight of the market. The study includes porters five forces model, attractiveness analysis, raw material analysis, and competitor position grid analysis.

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Global Scaffold Technology Market Is Expected to Reach USD 2.16 billion by 2028 : Fior Markets - GlobeNewswire

Recombinant Growth Factors to Account for Over 45% of Overall Demand through 2031: Persistence Market Research – PRNewswire

NEW YORK, Feb. 18, 2021 /PRNewswire/ -- Cell culture supplements are the backbone of culturing methods and techniques in mammalian and microbial cell culture. Routinely performed cell-based assays and cell expansion processes require several growth factors to boost cell growth in the culture. Recombinant cell culture supplements serve an array of applications, such as stem cell research, drug discovery, oncology research, and regenerative medicine. Recombinant cell culture supplements and growth factors are used for culturing stem cells for expansion and differentiation into other cell types. Stem cell research is growing and adoption is increasing with time. Recombinant cell culture supplements such as albumin and transferrin are key components of mammalian cell culture. Increasing bioprocessing activities for production of novel biologics are likely to upswing the growth of the recombinant cell culture supplements market over the coming years.

These days, a majority of supplements used in research and manufacturing are produced using recombinant technology. Recombinant supplements play an important role in gene and cell therapy. Cell therapy requires to grow the cells outside the human body, i.e. in-vitro, and, recombinant cell culture supplements are inevitable for such applications. Due to rapid development within the biopharmaceutical industry, recombinant cell culture supplements are anticipated to witness significant demand through 2031.

According to a latest report published by Persistence Market Research, the global recombinant cell culture supplements market was valued at US$ 441 Mn in 2020, and is predicted to witness an impressive CAGR of over 6% during the forecast period (2021 2031).

Key Takeaways from Recombinant Cell Culture Supplements Market Study

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"Increasing drug discovery and preference for recombinant technology for bio- production will upswing the global recombinant cell culture supplements market," says an analyst of Persistence Market Research.

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Collaborations & Acquisitions Key Strategies amongst Market Players

Prominent players in the recombinant cell culture supplements market are firming their product ranges through acquisitions and reaching out to emerging markets. Increasing investments and manufacturing capacity expansion are expected to favour the growth the global market over the forecast period

Various players in the recombinant cell culture supplements market are focusing on growth strategies such as acquisitions and collaborations.

What Does the Recombinant cell culture supplements Market Report Cover?

Persistence Market Research offers a unique perspective and actionable insights on the recombinant cell culture supplements market in its latest study, presenting historical demand assessment of 2016 2020 and projections for 2021 2031, on the basis of product (recombinant growth factors, recombinant insulin,recombinant albumin, recombinant transferrin,recombinant trypsin, recombinant aprotinin, recombinant lysozyme, and others), application (stem cell therapy, gene therapy,bioprocess application,vaccine development, and others), source (animals, microorganisms, andhumans), and end user (academic and research institutes,biopharmaceutical companies,cancer research centers, and contract research centers (CROs)), across seven key regions of the world.

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Recombinant Growth Factors to Account for Over 45% of Overall Demand through 2031: Persistence Market Research - PRNewswire

The Untapped Potential of Cell and Gene Therapy – AJMC.com Managed Markets Network

We can absolutely cut the number of cancer deaths down so that one day in our lifetimes it can be a rare thing for people to die of cancer, said Patrick Hwu, MD, president and CEO of Moffitt Cancer Center in Florida and among gene therapys pioneers. It still may happen here and there, but itll be kind of like people dying of pneumonia. Its like, He died of pneumonia? Thats kind of weird. I think cancer can be the same way.

The excitement returned in spades in 2017 when the FDA signed off on a gene-therapy drug for the first time, approving the chimeric antigen receptor (CAR) T-cell treatment tisagenlecleucel (Kymriah; Novartis) for the treatment of B-cell precursor acute lymphoblastic leukemia. At last, scientists had devised a way to reprogram a persons own T cells to attack tumor cells.

Were entering a new frontier, said Scott Gottlieb, MD, then the FDA Commissioner, in announcing the groundbreaking approval.

Gottlieb wasnt exaggerating. The growth in CAR T-cell treatments is exploding. Although only a handful of cell and gene therapies are on the market, FDA officials predicted in 2019 that the agency will receive more than 200 investigational new drug applications per year for cell and gene therapies, and that by 2025, it expects to have accelerated to 10 to 20 cell and gene therapy approvals per year.1

Essentially, you can kill any cancer cell that has an antigen that is recognized by the immune cell, Hwu said. The key to curing every single cancer, which is our goal, is to have receptors that can recognize the tumor but dont recognize the normal cells. Receptors recognizing and then attacking normal cells is what can cause toxicity.

Cell therapy involves cultivating or modifying immune cells outside the body before injecting them into the patient. Cells may be autologous (self-provided) or allogeneic (donor-provided); they include hematopoietic stem cells and adult and embryonic stem cells. Gene therapy modifies or manipulates cell expression. There is considerable overlap between the 2 disciplines.

Juliette Hordeaux, PhD, senior director of translational research for the University of Pennsylvanias gene therapy program, is cautious about the FDAs predictions, saying shed be thrilled with 5 cell and/or gene therapy approvals annually.

For monogenic diseases, there are only a certain number of mutations, and then well plateau until we reach a stage where we can go after more common diseases, Hordeaux said.

Safety has been the main brake around adeno-associated virus vector (AAV) gene therapy, added Hordeaux, whose hospitals program has the institutional memory of both Jesse Gelsingers tragic death during a 1999 gene therapy trial as well as breakthroughs by Carl June, MD, and others in CAR T-cell therapy.

Sometimes there are unexpected toxicity [events] in trials.I think figuring out ways to make gene therapy safer is going to be the next goal for the field before we can even envision many more drugs approved.

In total, 3 CAR T-cell therapies are now on the market, all targeting the CD19 antigen. Tisagenlecleucel was the first. Gilead Sciences received approval in October 2017 for axicabtagene ciloleucel (axi-cel; Yescarta), a CAR T-cell therapy for adults with large B-cell non-Hodgkin lymphoma. Kite Pharma, a subsidiary of Gilead, received an accelerated approval in July 2020 for brexucabtagene autoleucel (Tecartus) for adults with relapsed or refractory mantle cell lymphoma.

On February 5, 2021, the FDA approved another CD19-directed therapy for relapsed/refractory large B-cell lymphoma, lisocabtagene maraleucel (liso-cel; JCAR017; Bristol Myers Squibb). The original approval date was missed due to a delay in inspecting a manufacturing facility (see related article).

Idecabtagene vicleucel (ide-cel; bb2121; Bristol Myers Squibb) is under priority FDA review, with a decision expected by March 31, 2021. The biologics license application seeks approval for ide-cel, a B-cell maturation antigendirected CAR therapy, to treat adult patients with multiple myeloma who have received at least 3 prior therapies.2

The number of clinical trials evaluating CAR T-cell therapies has risen sharply since 2015, when investigators counted a total of 78 studies registered on the ClinicalTrials.gov website. In June 2020, the site listed 671 trials, including 357 registered in China, 256 in the United States, and 58 in other countries.3

Natural killer (NK) cells are the research focus of Dean Lee, MD, PhD, a physician in the Division of Hematology and Oncology at Nationwide Childrens Hospital. He developed a method for consistent, robust expansion of highly active clinical-grade NK cells that enables repeated delivery of large cell doses for improved efficacy. This finding led to several first-in-human clinical trials evaluating adoptive immunotherapy with expanded NK cells under an FDA Investigational New Drug application. He is developing both genetic and nongenetic methods to improve tumor targeting and tissue homing of NK cells. His eff orts are geared toward pediatric sarcomas.

The biggest emphasis over the past 20 to 25 years has been cell therapy for cancer, talking about trying to transfer a specific part of the immune system for cells, said Lee, who is also director of the Cellular Therapy and Cancer Immunology Program at Nationwide Childrens Hospital, at The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital, and at the Richard J. Solove Research Institute.

The Pivot Toward Treating COVID-19 and Other Diseases

However, Lee said, NKs have wider potential. This is kind of a natural swing back. Now that we know we can grow them, we can reengineer them against infectious disease targets and use them in that [space], he said.

Lee is part of a coronavirus disease 2019 (COVID-19) clinical trial, partnering with Kiadis, for off-the-shelf K-NK cells using Kiadis proprietary platforms. Such treatment would be a postexposure preemptive therapy for treating COVID-19. Lee said the pivot toward treating COVID-19 with cell therapy was because some of the very early reports on immune responses to coronavirus, both original [SARS-CoV-2] and the new [mutation], seem to implicate that those who did poorly [overall] had poorly functioning NK cells.

The revolutionary gene editing tool CRISPR is making its initial impact in clinical trials outside the cancer area. Its developers, Jennifer Doudna, PhD, and Emmanuelle Charpentier, PhD, won the Nobel Prize in Chemistry 2020.

For patients with sickle cell disease (SCD), CRISPR was used to reengineer bone marrow cells to produce fetal hemoglobin, with the hope that the protein would turn deformed red blood cells into healthy ones. National Public Radio did a story on one patient who, so far, thanks to CRISPR, has been liberated from the attacks of SCD that typically have sent her to the hospital, as well from the need for blood transfusions.4

Its a miracle, you know? the patient, Victoria Gray of Forest, Mississippi, told NPR.

She was among 10 patients with SCD or transfusion-dependent beta-thalassemia treated with promising results, as reported by the New England Journal of Medicine.5 Two different groups, one based in Nashville, which treated Gray,5 and another based at Dana-Farber Cancer Institute in Boston,6 have reported on this technology.

Stephen Gottschalk, MD, chair of the department of bone marrow transplantation and cellular therapy at St Jude Childrens Research Hospital, said, Theres a lot of activity to really explore these therapies with diseases that are much more common than cancer.

Animal models use T cells to reverse cardiac fibrosis, for instance, Gottschalk said. Using T cells to reverse pathologies associated with senescence, such as conditions associated with inflammatory clots, are also being studied.

Hordeaux said she foresees AAV being used more widely to transmit neurons to attack neurodegenerative diseases.

The neurons are easily transduced by AAV naturally, she said. AAV naturally goes into neurons very efficiently, and neurons are long lived. Once we inject genetic matter, its good for life, because you dont renew neurons.

Logistical Issues

Speed is of the essence, as delays in producing therapies can be the difference between life and death, but the approval process takes time. The process of working out all kinks in manufacturing also remains a challenge. Rapid production is difficult, too, because of the necessary customization of doses and the need to ensure a safe and effective transfer of cells from the patient to the manufacturing center and back into the patient.7

Other factors that can slow down launches include insurance coverage, site certification, staff training, reimbursement, and patient identification. The question of how to reimburse has not been definitively answered; at this point, insurers are being asked to issue 6- or even 7-figure payments for treatments and therapies that may not work.8

CAR T, I think, will become part of the standard of care, Gottschalk said. The question is how to best get that accomplished. To address the tribulations of some autologous products, a lot of groups are working with off -the-shelf products to get around some of the manufacturing bottlenecks. I believe those issues will be solved in the long run.

References

1. Statement from FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. News release. FDA website. January 15, 2019. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics. Accessed January 13, 2021.

2. Bristol Myers Squibb provides regulatory update on lisocabtagene maraleucel (liso-cel). News release. Bristol Myers Squibb; November 16, 2020. Accessed January 11, 2021. https://news.bms.com/news/details/2020/Bristol-Myers-Squibb-Provides-Regulatory-Update-on-Lisocabtagene-Maraleucel-liso-cel/default.aspx

3. Wei J, Guo Y, Wang Y. et al. Clinical development of CAR T cell therapy in China: 2020 update. Cell Mol Immunol. Published online September 30, 2020. doi:10.1038/s41423-020-00555-x

4. Stein R. CRISPR for sickle cell diseases shows promise in early test. Public Radio East. November 19, 2019. Accessed January 11, 2021. https://www.publicradioeast.org/post/crisprsickle-cell-disease-shows-promise-early-test

5. Frangoul H, Altshuler D, Cappellini MD, et al. CRISPR-Cas9 gene editing for sickle cell disease and -Thalassemia. N Engl J Med. Published online December 5, 2020. DOI: 10.1056/NEJMoa2031054

6. Esrick EB, Lehmann LE, Biffi A, et al. Post-transcriptional genetic silencing of BCL11A to treat sickle cell disease. N Engl J Med. Published online December 5, 2020. doi:10.1056/NEJMoa2029392

7. Yednak C. The gene therapy race. PwC. February 5, 2020. Accessed January 11, 2021. https://www.pwc.com/us/en/industries/healthindustries/library/gene-therapy-race.html

8. Gene therapies require advanced capabilities to succeed after approval. PwC website. Accessed January 11, 2021. https://www.pwc.com/us/en/industries/health-industries/library/commercializing-gene-therapies.html

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The Untapped Potential of Cell and Gene Therapy - AJMC.com Managed Markets Network

Cell Therapy Processing Market To Grow Value $12062 Million By 2026 | Latest Research Report – PharmiWeb.com

Pune, Maharashtra, India, February 17 2021 (Wiredrelease) Allied Analytics :According to the report published by Allied Market Research, the global The cell therapy processing market was valued at $1,695 million in 2018, and is projected to reach $12,062 million by 2026, registering a CAGR of 27.8% from 2019 to 2026.

Cell Therapy Processing Market by Offering Type (Products, Services, and Software), and Application (Cardiovascular Devices, Bone Repair, Neurological Disorders, Skeletal Muscle Repair, Cancer, and Others): Global Opportunity Analysis and Industry Forecast, 20192026.

Prime determinants of growth

Increase in the incidence of cardiovascular diseases and surge in the demand for chimeric antigen receptor (CAR) cell therapy propel the global cell therapy processing market. However, poor demand from underdeveloped countries hinders the market growth. On the other hand, emerging markets are expected offer lucrative opportunities in the near future.

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The skeletal muscle repair segment to maintain its lions share in terms of revenue by 2026

Based on application, the skeletal muscle segment accounted for the largest market share of the global cell therapy processing market in 2018, accounting for more than one-fifth of the total market share in 2018. Moreover, the neurological disorders segment is estimated to grow at the highest CAGR of 29.7% from 2019 to 2026. The use of fetal neural tissue for cell therapy presented the first unambiguous proof that such grafts can be used to grow, evolve, and recover functional defects in rodents to varying degrees, which boosts the growth of the segment.

The growth of the cell therapy processing market is attributed to increase in the incidence of cardiovascular diseases. Furthermore, rise in the demand for chimeric antigen receptor (CAR) t cell therapy, and increase in the development of stem cell therapy approaches globe are the other factors that contribute to the growth of the cell therapy processing market.

Based on offering type, the market is categorized into products, services, and software. Presently, products dominates the cell therapy processing market, and is anticipated to continue this trend over the forecast period. The key factors that driving the market growth are rise in the incidence of cardiovascular diseases, increase in demand for cell therapy processing, surge in adoption of allogeneic cell therapy, and introduction of novel technologies for cell therapy processing drives the market growth of this segment.

North Americato maintain its dominance during the forecast period

Based on region,North Americaaccounted for the highest market share in terms of revenue, accounting for nearly two-fifths of the global cell therapy processing market in 2018, and is estimated to maintain its dominance during the forecast period. This is attributed to presence of well-established healthcare infrastructure, higher buying power, and surge adoption of advanced medical therapies. In addition, rise in prevalence of osteoporosis coupled with surge in geriatric population fuels the growth of the market in this region. Moreover,Asia-Pacificis expected to maintain the highest CAGR of 29.0% from 2019 to 2026, owing to presence of huge patient base, increase in research and development expenditure, and surge in usage of cell therapy processing products.

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Leading market players

Invitrx Inc.

Cell Therapies Pty Ltd

Lonza Ltd

Merck & Co., Inc (FloDesign Sonics)

NantWorks, LLC

Neurogeneration, Inc.

Novartis AG

Plasticell Ltd.

Regeneus Ltd

StemGenex, Inc.

North America accounted for approximately one-half of the global cell therapy processing market share in 2018 and is expected to remain dominant throughout the forecast period. This was attributed to increase in the popularity of stem cell research, rise in patient awareness towards stem cell therapies, and well developed healthcare infrastructure. On the other side, Asia-Pacific is expected to experience the highest growth rate during the forecast period majorly due to improvement in healthcare infrastructure, rise in number of hospitals equipped with advanced medical facilities, the developing R&D sector, rise in healthcare reforms, and technological advancements in the field of healthcare.

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Excerpt from:
Cell Therapy Processing Market To Grow Value $12062 Million By 2026 | Latest Research Report - PharmiWeb.com