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EV Biologics To Perform Specialized Analysis of EV Biopharmaceuticals at Vanderbilt University – BioSpace

CHEYENNE, WY / ACCESSWIRE / September 29, 2020 / EV Biologics, Inc. formerly Yulong Eco-Materials Limited (OTC PINK:YECO) today announced that it intends to utilize the advanced instrumentation and research staff at the Vanderbilt Institute of Nanoscale Science and Engineering (VINSE) and the Vanderbilt Center for Structural Biology (CSB) in the development of extracellular vesicle (EV)-based diagnostics and therapeutics.

Founded in 1873, Vanderbilt University located in Nashville, Tennessee is a pre-eminent and legendary private research university comprised of 10 distinct schools and colleges on one centralized campus. Regularly ranked as one of the nation's top 15 universities by publications such as "U.S. News & World Report", with programs that rank in the top 10, Vanderbilt is a world-class institution. The University was recently ranked #10 in Reuter's assessment of the World's Most Innovative Universities. (Source: Vanderbilt University Website - https://www.vanderbilt.edu/csb).

Quality Control (QA/QC) is the cornerstone of the Company's plan for Current Good Manufacturing Practices cGMP development of EV diagnostics and therapeutic products. The Vanderbilt CSB and VINSE are extraordinary research facilities that have the capability of performing nanoscale analytical methods such as Atomic Force Microscopy, Electron Microscopy and Nano Tracking Analysis. The Vanderbilt University research staff has extensive experience with nanoparticle characterization methods that will form an essential part of QA/QC for the Company's therapeutic development.

The Company is making a significant investment in its own analytical equipment to facilitate novel solutions to overcome the challenges in EV product characterization and standardization. EV analysis performed by research staff at Vanderbilt will complement and confirm the Company's own EV development data and will provide the orthogonal characterization for EV research recommended by the International Society for Extracellular Vesicles.

CMO, Dr. Jason Sanders, said "having access to this kind of extremely specialized instrumentation and experts in nanoparticle analysis at such a highly respected institution as Vanderbilt will be instrumental in advancing our R&D program for biopharmaceuticals and will enable meticulous analysis for preparation of Investigational New Drug applications (IND's) to the FDA for maximum efficiency in EV drug development."

The Company is currently in the process of getting a new trading symbol with FINRA after successfully getting our name changed. Our goal is to become current in our OTC filings by the end of October with OTC Markets

About the Company

EV Biologics (formerly Yulong Eco-Materials Limited) is a Wyoming, USA domiciled Biotechnology Company, intent on bringing human mesenchymal "MSC" and other stem cell and cell-derived products to market in the cosmetic and biopharmaceutical spaces. Initially, these novel and unique products will be specifically provided to the international clinical research community including universities and physicians and will be targeted to the aesthetic and regenerative medicine markets. Using proprietary and patentable technologies, the Company is creating exclusive IP and IT inherent in our superior products. Further product development will be focused on investigation of novel stem cell-derived biopharmaceuticals designed for specific clinical conditions.

Forward-Looking Statements

This press release contains forward-looking statements, particularly as related to, among other things, the business plans of the Company, statements relating to goals, plans and projections regarding the Company's financial position and business strategy. The words or phrases "plans," "would be," "will allow," "intends to," "may result," "are expected to," "will continue," "anticipates," "expects," "estimate," "project," "indicate," "could," "potentially," "should," "believe," "think," "considers" or similar expressions are intended to identify "forward-looking statements." These forward-looking statements fall within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934 and are subject to the safe harbor created by these sections. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of local, regional, and global economic conditions, the performance of management and our employees, our ability to obtain financing, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date, and the Company specifically disclaims any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

YECO has 6.21 million shares issued and outstanding with a float of 1,016,375 shares.

Contact:

Dennis Burns Investor Relations Tel(567)237-4132 dburns@nvestrain.com

For more information on EV Biologics please visit: http://www.evbiologics.com

SOURCE: Yulong Eco-Materials Limited

View source version on accesswire.com: https://www.accesswire.com/608226/EV-Biologics-To-Perform-Specialized-Analysis-of-EV-Biopharmaceuticals-at-Vanderbilt-University

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EV Biologics To Perform Specialized Analysis of EV Biopharmaceuticals at Vanderbilt University - BioSpace

JAMA Oncology Highlights Plinabulin’s Efficacy in Preventing Chemotherapy-Induced Neutropenia as a Monotherapy – GlobeNewswire

September 29, 2020 08:00 ET | Source: BeyondSpring, Inc.

NEW YORK, Sept. 29, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on developing innovative immuno-oncology therapies to transform the lives of patients with unmet medical needs, today announced that the Companys manuscript, titled Efficacy of Plinabulin vs. Pegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Adults With Non-Small Cell Lung Cancer, has been published in JAMA Oncology, the American Medical Associations peer-reviewed journal.

The manuscript analyzed BeyondSprings Phase 2 portion of its PROTECTIVE-1 (Study 105) randomized clinical trial, which consisted of four treatment arms and was conducted in 19 treatment centers in the U.S., China, Russia and Ukraine from April 2017 through March 2018, with Covance serving as its contract research organization. Key primary and secondary endpoints were calculated using objective data, such as the absolute neutrophil count and platelet counts, which were based on validated assays conducted at Covances central labs in three continents. Participants were adult patients with non-small cell lung cancer (NSCLC) whose cancer had progressed after platinum-based chemotherapy. The objective was to assess the efficacy and safety of the Companys lead asset, Plinabulin, compared with Pegfilgrastim, a long-lasting G-CSF, which is currently the predominant therapy for chemotherapy-induced neutropenia (CIN) prevention.

The protocols were as follows:

Key results included:

The data presented demonstrates that Plinabulin a novel, non-G-CSF small molecule with anticancer activity has potent neutropenia prevention effects, said Dr. Douglas Blayney, Principal Investigator of BeyondSprings CIN program with Plinabulin. The results show the promise that Plinabulin has to deliver relief to cancer patients suffering around the world.

The results of this study validate Plinabulins strength and its potent ability to prevent CIN in cancer patients, added Dr. Ramon Mohanlal, BeyondSprings Chief Medical Officer and Executive Vice President, Research and Development. This study, coupled with the breakthrough designation granted to our CIN program from boththeU.S. FDAand China NMPA,is highly encouraging for our pending New Drug Application filings in bothcountries.

To access the full e-publication, please visit: https://jamanetwork.com/journals/jamaoncology/article-abstract/2770700.

About BeyondSpring Headquartered in New York, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSprings first-in-class lead immune asset, Plinabulin, is a potent antigen-presenting cell (APC) inducer. It is currently in two Phase 3 clinical trials for two severely unmet medical needs indications: one is for the prevention of chemotherapy-induced neutropenia (CIN), the most frequent cause for a chemotherapy regimen doses decrease, delay, downgrade or discontinuation, which can lead to suboptimal clinical outcomes. The other is for non-small cell lung cancer (NSCLC) treatment in EGFR wild-type patients. As a pipeline drug, Plinabulin is in various I/O combination studies to boost PD-1 / PD-L1 antibody anti-cancer effects. In addition to Plinabulin, BeyondSprings extensive pipeline includes three pre-clinical immuno-oncology assets and a drug discovery platform dubbed molecular glue that uses the protein degradation pathway.

About Plinabulin Plinabulin, BeyondSprings lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulins CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSprings most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts Caitlin Kasunich / Raquel Cona KCSA Strategic Communications ckasunich@kcsa.com / rcona@kcsa.com

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JAMA Oncology Highlights Plinabulin's Efficacy in Preventing Chemotherapy-Induced Neutropenia as a Monotherapy - GlobeNewswire

Research Report and Overview on Stem Cell Cryopreservation Equipments Market, 2020-2027 with , Chart, Worthington Industries, Cesca Therapeutics,…

(September 2020):WMRsLatest Study on Stem Cell Cryopreservation Equipments Market report 2020-2027 providesan Overview of the current market situation,competitive analysis, product scope, market research, opportunities, driving force, and market risks. The report contains market forecast to 2027 related to market size, Consumption, gross margin, price,revenue, production, CAGR and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.

The Stem Cell Cryopreservation Equipments market report provides a basic overview of the industry, including definitions, classifications, applications, and chain structures. Stem Cell Cryopreservation Equipments market analysis is provided to international markets, including development trends, competitive environment analysis, and key regions development status.

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Stem Cell Cryopreservation Equipments Market Segments Analysis Covers;

The major manufacturers covered in this report: , Chart, Worthington Industries, Cesca Therapeutics, Shengjie Cryogenic Equipment, Sichuan Mountain Vertical, Qingdao Beol,

Considering keyword Market factors, Types Covers: Liquid Phase, Vapor Phase,

Application Covers: Cord Blood Stem Cell Cryopreservation, Other Stem Cell Cryopreservation

Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; emergency declared in many countries; massive slowing of the supply chain; stock market unpredictability; falling business assurance, growing panic among the population, and uncertainty about future.

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Table of Content (TOC) of Stem Cell Cryopreservation Equipments Market 2020:Chapter 1 Introduction and Overview Chapter 2 Industry Cost Structure and Economic Impact Chapter 3 Rising Trends and New Technologies with Major key players Chapter 4 Global Stem Cell Cryopreservation Equipments Market Analysis, Trends, Growth Factor Chapter 5 Stem Cell Cryopreservation Equipments Market Application and Business with Potential Analysis Chapter 6 Global Stem Cell Cryopreservation Equipments Market Segment, Type, Application Chapter 7 Global Stem Cell Cryopreservation Equipments Market Analysis (by Application, Type, End-User) Chapter 8 Major Key Vendors Analysis of Stem Cell Cryopreservation Equipments Market Chapter 9 Development Trend of Analysis Chapter 10 Covid-19 Analysis Chapter 10 Conclusion

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Research Report and Overview on Stem Cell Cryopreservation Equipments Market, 2020-2027 with , Chart, Worthington Industries, Cesca Therapeutics,...

Orgenesis Announces Agreement to Acquire Koligo Therapeutics, a Leader in Personalized Cell Therapies – GlobeNewswire

September 29, 2020 06:30 ET | Source: Orgenesis Inc.

Acquisition to support accelerated commercialization of Koligos KYSLECEL,a personalized islet cell therapy available in the U.S. for chronic and recurrent acute pancreatitis

Goal to rapidly advance KT-PC-301, an autologous cell therapy under investigationfor the treatment of COVID-19-related Acute Respiratory Disease Syndrome (ARDS)

Orgenesis to leverage Koligos 3D-V bioprinting technology across its POCare Platform

GERMANTOWN, Md., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (Orgenesis or the Company), a global biotech company working to unlock the full potential of cell and gene therapies, and Koligo Therapeutics, Inc. (Koligo), a regenerative medicine company, today announced that the two companies have entered into a definitive merger agreement, subject to final closing conditions, with expected completion before year-end (Transaction).

Koligo is a leader in developing personalized cell therapies utilizing the patients own (autologous) cells. Koligo has successfully launched its first commercial product, KYSLECEL, and plans to commence a phase 2 trial of KT-PC-301 for COVID-19-related ARDS. Koligos development stage technology utilizes 3D bioprinting and vascularization with autologous cells (3D-V technology) to create biodegradable and shelf-stable three-dimensional cell and tissue implants. The 3D-V technology is being developed for diabetes and pancreatitis, with longer term applications for neural, liver, and other cell/tissue transplants.

Following closing of the Transaction, Orgenesis plans to accelerate the commercial scaleup of KYSLECEL throughout the United States and, subject to regulatory and logistical considerations, in international markets as well. After closing of the Transaction, and subject to FDA review and clearance of the Companys Investigational New Drug application, Orgenesis expects to start patient recruitment for a phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. Orgenesis also plans to leverage Koligos 3D-V bioprinting technology across its POCare platform.

Under the terms of the merger agreement, Orgenesis will acquire all of the outstanding stock of Koligo from its shareholders (the founders and staff of Koligo and a subsidiary of Bergen Special Opportunity Fund, LP, an institutional investor managed by Bergen Asset Management, LLC). The agreed consideration terms are an aggregate of $15 million in shares of Orgenesis common stock valued at $7.00 per share which shall be issued to Koligos accredited investors (with certain non-accredited investors to be paid solely in cash) and an assumption of $1.3 million in Koligos liabilities, estimated to be substantially all of Koligos liabilities. Additional details of the Transaction will be available in the Companys Form 8-K, which will be filed with the Securities and Exchange Commission, and will be available at http://www.sec.gov.

KYSLECEL Koligos KYSLECEL is commercially available in the United States for chronic and recurrent acute pancreatitis in a surgical procedure commonly called Total Pancreatectomy with Islet Autologous-Transplant (TPIAT). TPIAT has been proven to provide significant pain relief, improved quality of life, and a reduction in the need for pain medication for patients suffering from chronic or recurrent acute pancreatitis. KYSLECEL infusion after a total pancreatectomy helps preserve insulin secretory capacity and reduce the risk of diabetic complications. KYSLECEL is made from a patients own pancreatic islets the cells that make insulin to regulate blood sugar.

Koligo has commenced its commercial pilot program for KYSLECEL at six U.S. hospitals, treating 40 patients to date. The KYSLECEL pilot program has generated approximately $2 million in sales revenue. KYSLECEL has also been shown to result in significant savings to payors over traditional chronic pancreatitis management. Following the closing of the Transaction, Orgenesis plans to make KYSLECEL available to an increasing number of hospitals throughout the United States through its POCare Network.

KT-PC-301 Koligos lead clinical development program is for KT-PC-301, an autologous cell therapy under investigation for the treatment of COVID-19-related Acute Respiratory Disease Syndrome (ARDS). KT-PC-301 is comprised of autologous stromal and vascular fraction cells (SVF) derived from each patients adipose (fat) tissue. KT-PC-301 contains a population of mesenchymal stem cells, vascular endothelial cells, and immune cells which migrate to the patients lungs and other peripheral sites of inflammation. Nonclinical and clinical evidence demonstrate that KT-PC-301 may: (1) stabilize microcirculation to improve oxygenation; (2) maintain T and B lymphocytes to support antibody production; and (3) induce an anti-inflammatory effect.

Koligo has completed a pre-IND (Investigational New Drug) consultation with the U.S. Food and Drug Administration to start clinical trials of KT-PC-301 in COVID-19-related ARDS. Following the closing of the Transaction, and subject to FDA review and clearance of the Companys Investigational New Drug application, Orgenesis expects to start patient recruitment for a phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. As currently planned, the phase 2 trial is expected to enroll 75 patients and evaluate the safety and efficacy of KT-PC-301. Mohamed Saad, MD, Chief of Division of Pulmonary, Critical Care, and Sleep Disorders Medicine at the University of Louisville, will be the lead clinical investigator on the trial.

3D-V Technology Koligos 3D-V bioprinting technology is designed to support development of a number of product candidates for the treatment of diabetes, cancer, neurodegenerative disease, and other serious diseases. The 3D-V technology platform is able to print three-dimensional cell and tissue constructs with a vascular network. Key benefits of the 3D-V approach include: faster revascularization/inosculation of cell/tissue transplant to improve engraftment; host tolerance of the graft while minimizing need for immune suppressive drugs; better site of transplant administration of such products; and scaffolding to keep cell/tissue in place in vivo. These solutions are ideally suited for islet transplant and other cell/tissue transplant applications.

Koligo Management Following the closing of the Transaction, Koligos management team will be joining Orgenesis to continue commercial and development activities. Koligos CEO, Matthew Lehman, is an accomplished executive in the biotech and regenerative medicine fields. Prior to co-founding Koligo, he was CEO of Prima Biomed Ltd (now Immutep Ltd, a Nasdaq (IMMP) and ASX (IMM) listed biotech company). Stuart Williams, PhD, Chief Technology Officer, is a bioengineer and thought leader in regenerative medicine, with over 300 publications and 20 issued patents in the field. Dr. Williams has co-founded three other biotech companies and is an experienced academic-industry collaborator. Michael Hughes, MD, Chief Medical Officer, is a transplant surgeon who started the islet transplant program at University of Louisville which was the genesis of Koligos KYSLECEL program. He has successfully treated nearly 50 chronic pancreatitis patients with islet autologous transplant after pancreatectomy. Balamurugan Appakalai, PhD, has more than 20 years of islet isolation experience, having processed more than 800 human pancreases. He is a leader in the field of islet transplant with 100+ publications.

Vered Caplan, Chief Executive Officer of Orgenesis, stated, We are pleased to announce this transformative acquisition, which we expect will add broad capabilities to our therapeutic and technology platform, and will further our leadership in the cell and gene therapy field. Based on several phase 1 studies, Koligos KT-PC-301, using a patients own cells, has demonstrated safety and tolerability, and has shown signs of efficacy to support continued development in COVID-19-related ARDS. If successful for the treatment of COVID-19-related ARDS, KT-PC-301 is likely to have applications in other acute and chronic respiratory indications, areas that represent significant unmet medical need. In addition, we see significant potential in KYSLECEL, a commercial stage asset for the treatment of chronic and acute recurrent pancreatitis, which we plan to introduce through our global network of hospitals. Finally, Koligos 3D-V bioprinting technology is highly complementary to our POCare Platform, as we implement new technologies to improve efficacy and lower the costs of cell and gene therapies. I would like to personally welcome Matthew and the rest of the Koligo team to the Orgenesis organization when the Transaction closes. We believe that their skills and experience will be an important addition as we execute on our strategy to unlock the power of cell and gene therapies and make them accessible to all.

Matthew Lehman, Chief Executive Officer of Koligo Therapeutics, stated, The merger with Orgenesis marks a major milestone for our company and builds on our recent progress, including the Pre-IND package submitted to the U.S. FDA for KT-PC-301 and our pilot commercial program for KYSLECEL. The Orgenesis team brings extensive clinical, regulatory, and manufacturing expertise well suited to supporting Koligos goals. Orgenesis intellectual property is highly complementary to Koligos technology and the combined companies will work to advance a robust commercial and development product portfolio. Orgenesis POCare technologies are also ideally suited for low-cost and efficient production of autologous cell therapies at the point of care, which we believe will considerably enhance the delivery of these therapies to patients. Additionally, we believe Orgenesis global network of leading hospitals and healthcare institutions will enable us to accelerate the commercial rollout of KYSLECEL. We are quite encouraged by the outlook for the business and look forward to leveraging Orgenesis POCare Platform in order to accelerate the timeline to bringing our innovative cell therapies to market. Through this merger, we believe we can maximize value for all shareholders and we are grateful to Orgenesis for this opportunity.

Pearl Cohen Zedek Latzer Baratz LLP and KPMG advised Orgenesis on the Transaction. Maxim Group LLC acted as a finder and Nelson Mullins Riley & Scarborough, LLP advised Koligo on the Transaction.

About Koligo Therapeutics Koligo Therapeutics, Inc. is a US regenerative medicine company. Koligos first commercial product is KYSLECEL (autologous pancreatic islets) for chronic and acute recurrent pancreatitis. Koligos 3D-V technology platform incorporates the use of advanced 3D bioprinting techniques and vascular endothelial cells to support development of transformational cell and tissue products for serious diseases. More information is available at http://www.koligo.net.

About OrgenesisOrgenesis is a global biotech company working to unlock the full potential of celland gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCarePlatform is comprised of three enabling components: a pipeline of licensedPOCare Therapeuticsthat are processed and produced in closed, automatedPOCare Technologysystems across a collaborativePOCare Network. Orgenesisidentifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. Learn more about the work Orgenesis is doing atwww.orgenesis.com.

Notice Regarding Forward-Looking Statements The information in this release is as of September 29, 2020. Orgenesis assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments. This release contains forward looking statements about Orgenesis, Koligo, Koligos technology, and potential development and business opportunities of Koligo and Orgenesis following the closing of the Transaction, each of which involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of the Companys products; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any such regulatory authorities may approved the Companys development products, and, if approved, whether such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of the Companys products; uncertainties regarding the impact of COVID-19 on the Companys business, operations and financial results and competitive developments.

A further description of risks and uncertainties can be found in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov.

Contact for Orgenesis: Crescendo Communications, LLC Tel: 212-671-1021 ORGS@crescendo-ir.com

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Orgenesis Announces Agreement to Acquire Koligo Therapeutics, a Leader in Personalized Cell Therapies - GlobeNewswire

Singapore inks research collaboration with India for biotherapeutics – BSA bureau

Manipal Academy of Higher Education (MAHE) in India and Esco Aster in Singapore have signed agreement to establish collaborative research unit at MAHE, Manipal

This is the second Esco Aster collaborative research unit set up globally after the firstCentre of Excellence (COE) with Bioprocessing Technology Institute (BTI), Singapore. Esco Aster hopes to continue to develop more collaborations in Asia Pacific in years to come to work on the booming cell and gene therapy.

As per the agreement, ESCO Aster and MAHE will jointly establish a research unit at MAHE Manipal campus to carry outactivities related to development and manufacturing in the biotherapeutics area.MAHE will provide cGMP compliant facility and necessary resources for carrying out the research activities.

-Lt. General Dr. Venkatesh M.D., MAHEs Vice Chancellor

Weare excited to sign this agreement with MAHE and we look forward for harnessing the skilled manpower and mentor pool available at MAHE to build our pipeline products and services to our clients. We envision showcasing this research unit to our potential clients and collaborators and also utilizing it as a training centre.

-Xiangliang Lin, Esco Aster Chief Executive Officer

Through this agreement, both parties aim to facilitate research, development, and commercial plans and activities relating to stem cells or extracellular vesicles. Other fields of study with potential advantages to scientific discoveries are also welcome. This collaboration opens up potential breakthrough discoveries aiming to drive the biotherapeutics industry.

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Singapore inks research collaboration with India for biotherapeutics - BSA bureau

Whats on Your Local Ballot? – City News Group, Inc

On Monday October 5, 2020 early voting begins at the Registrar of Voters and mail ballots are delivered to the U.S. Postal Service- increasing the already present deadline for Election Day on November 3, 2020.

With early voting in full swing, the consumption of information on candidates and legislature is paramount. Knowing who and what will be on your ballot before Election Day, may provide you the time to get to know the people and legislature that impacts our community and day-to-day lives before you cast your vote. Get to know what California Propositions, County and City Measures are on your ballot this fall.

CountyofSanBernardinoMeasures

MeasureJ:

REVISEDCHARTEROFTHECOUNTYOFSANBERNARDINO

*Information for "Arguments in Favor" and "Arguments Against" is from the official arguments section on the voters ballot*

Argument in Favor:

San Bernardino County's charter - the laws that govern our community - was written more than 100 years ago. It's time to modernize our charter. Measure J will:

Argument Against:

Don't be fooled. This charter "reform" is not reform. It's a way for the county board of supervisors to lock out voters when it comes to decisions about term limits and compensation. Since elected Supervisors collect a salary of over $250,000 annually nearly six-times the median income of San Bernardino residents and can serve twelve long years, it's easy to understand their motives.

MeasureK

SANBERNARDINOCOUNTYSUPERVISORCOMPENSATIONREDUCTIONANDTERMLIMITS. This Measure would amend the San Bernardino County Charter provisions relating to the term limits and compensation of the members of the Board of Supervisors. San Bernardino County Charter Article I, Section 2 would be amended to impose a term limit of one-term for each Supervisor. The Measure would add Section 10 to Article I of the San Bernardino County Charter to set the total compensation for each member of the Board of Supervisors at $5,000 per month and would repeal San Bernardino County Charter Article VI, Section 1 that currently sets compensation for members of the Board of Supervisors.

Argument in Favor:

Voting YES for term limits and reduced salaries will finally attract representatives interested in public service and committed to following the will of the people.

Argument Against:

Measure K will result is less representation for residents of San Bernardino County on the Board of Supervisors. We need more representation, not less.

CityofSanBernardinoMeasure S:

TopreventreductionstoCityservicesincludingpublicsafety,911emergencyresponse,Currently, the City has a one-quarter percent (1/4%) retail transactions and use (sales) tax, that generates approximately $9 million annually. The current tax expires on March 31, 2022. If this Measure is approved by a majority of San Bernardino voters, this Measure would authorize an increase of the retail transactions and use (sales) tax from one-quarter percent (1/4%) to one percent (1%) within the City of San Bernardino.

Argument in Favor:

Vote YES on Measure S to provide a brighter future for San Bernardino. Measure S renews a critical source of local funding, prevents further cuts to essential city services, improves 911 emergency response, and protects local businesses and jobs here in San Bernardino

Argument Against:

No Argument Against Measure S was filed.

SanBernardinoCountyFireProtectionDistrictMeasure U

This Measure, if approved by a majority of those voting, would repeal the special tax associated with Fire Protection Service Zone Five (FP-5). County Service Area (CSA) 70, Improvement Zone FP-5 was formed on April 18, 2006. On August 1, 2006, a special tax was authorized following a two-thirds vote of registered voters in CSA 70, Improvement Zone FP-5 for fire and emergency medical services. The previously authorized special tax per parcel remained in effect in the reorganized FP-5. Over time, FP-5 has been expanded to include some cities and unincorporated territory in the County of San Bernardino.

Argument in Favor:

VOTE YES on Measure U to END THE UNFAIR FIRE TAX! Beginning in 2015, to save themselves money, politicians across San Bernardino County traded away local fire protection and joined a large, regional agency, saddling residents with a tax increase that penalizes poor and middle-class families the same as rich corporate property owners. This tax approved by only a small number of people, impacts over a million San Bernardino residents. In fact, over 99% of those impacted never had the chance to vote on dismantling local fire protection or paying a new tax!

Argument Against:

VOTE NO on Measure U Measure U is a DANGEROUS PROPOSAL to DEFUND FIRE PROTECTION services for residents in the communities served by the San Bernardino County Fire Protection District. Measure U ELIMINATES $40 MILLION in funding for Emergency Medical and Fire Protection services. It cuts essential life-saving services not budgetary fat. By REDUCING PARAMEDIC SERVICES, Measure U will WORSEN response times in life-threating medical emergencies putting our families at greater risk.

California State Propositions:

Proposition 14: AUTHORIZES BONDS CONTINUING STEM CELL RESEARCH. INITIATIVE STATUTE.

Authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine to educational, nonprofit, and private entities for: stem cell and other medical research, including training; stem cell therapy development and delivery; research facility construction; and associated administrative expenses. Increased state costs to repay bonds estimated at about $260 million per year over the next roughly 30 years.

Argument in Favor:

Prop. 14 provides continued funding to develop treatments, advance clinical trials and achieve new scientific breakthroughs for Californias patients with Cancer, Diabetes, Heart Disease, Alzheimers, Parkinsons, HIV/AIDS, ALS, MS, Sickle Cell Disease, Lung Diseases, Kidney Disease, Bubble Baby Disease, Age-Related Blindness and Genetic Blindness, Epilepsy, Stroke, Schizophrenia, Autism, other Mental Health and Brain Conditions, and Infectious Diseases like COVID-19.

Argument Against:

WE CANT AFFORD TO WASTE BILLIONS In the middle of an economic crisis, with soaring unemployment and budget shortfalls in the tens of billions of dollars, we dont have money to burn. We simply cannot afford the $5 billion that proponents of Prop. 14 are asking for. And thats on top of the nearly $3 billion this troubled state agency has spent over the past 15 yearswith poor results.

Proposition15: INCREASES FUNDING SOURCES FOR PUBLIC SCHOOLS COMMUNITY COLLEGES, AND LOCAL GOVERNMENT SERVICES BY CHANGING TAX ASSESSMENT OF COMMERCIAL AND INDUSTRIAL PROPERTY. INITIATIVE CONSTITUTIONAL AMENDMENT.

Increases funding sources for K12 public schools, community colleges, and local governments by requiring commercial and industrial real property be taxed based on current market value, instead of purchase price. Exempts from taxation changes: residential properties; agricultural land; and owners of commercial and industrial properties with combined value of $3 million or less.

Most owners of commercial land and buildings worth more than $3 million would pay higher property taxes. Only some of these property owners would start to pay higher taxes in 2022. By 2025, most of these property owners would pay higher taxes. Beginning in 2025, total property taxes from commercial land and buildings probably would be $8 billion to $12.5 billion higher in most years

Argument in Favor:

We are all better off when everyone pays their fair share. But California is giving away billions of dollars in property tax breaks to wealthy corporations. These billions could be used instead to deal with increasing inequality, persistent poverty, unemployment, unaffordable housing, homelessness and underfunded schools.

Argument Against:

PROP. 15 WILL BE THE LARGEST ANNUAL PROPERTY TAX INCREASE IN CALIFORNIA HISTORYUP TO $12.5 BILLION PER YEAR! Prop. 15s massive increase in annual property taxes will have disastrous economic impacts for every Californianfrom small businesses and consumers to farmers and homeowners.

Proposition16: ALLOWS DIVERSITY AS A FACTOR IN PUBLIC EMPLOYMENT, EDUCATION, AND CONTRACTING DECISIONS. LEGISLATIVE CONSTITUTIONAL AMENDMENT.

Permits government decision-making policies to consider race, sex, color, ethnicity, or national origin to address diversity by repealing article I, section 31, of the California Constitution, which was added by Proposition 209 in 1996. Proposition 209 generally prohibits state and local governments from discriminating against, or granting preferential treatment to, individuals or groups on the basis of race, sex, color, ethnicity, or national origin in the operation of public employment, education, or contracting.

Argument in Favor:

All of us deserve equal opportunities to thrive with fair wages, good jobs, and quality schools. Despite living in the most diverse state in the nation, white men are still overrepresented in positions of wealth and power in California. Although women, and especially women of color, are on the front lines of the COVID-19 response, they are not rewarded for their sacrifices. Women should have the same chance of success as men.

Argument Against:

REPEAL WOULD BE A STEP BACKWARD Discrimination of this kind is poisonous. It will divide us at a time we desperately need to unite. Politicians want to give preferential treatment to their favorites. They think they can fix past discrimination against racial minorities and women by discriminating against other racial minorities and men who are innocent of any wrongdoing. Punishing innocent people will only cause a never-ending cycle of resentment.

Proposition17: RESTORES RIGHT TO VOTE AFTER COMPLETION OF PRISON TERM. LEGISLATIVE CONSTITUTIONAL AMENDMENT.

Amends state constitution to restore voting rights to persons who have been disqualified from voting while serving a prison term as soon as they complete their prison term. Increased one-time state costs, likely in the hundreds of thousands of dollars, to update voter registration cards and to update voter registration cards and systems.

Argument in Favor:

Proposition 17 is simpleit restores a persons right to vote upon completion of their prison term. When a person completes their prison sentence, they should be encouraged to reenter society and have a stake in their community. Restoring their voting rights does that.

Argument Against:

PROPOSITION 17 WILL ALLOW CRIMINALS CONVICTED OF MURDER, RAPE, SEXUAL ABUSE AGAINST CHILDREN, KIDNAPPING, ASSAULT, GANG GUN CRIMES AND HUMAN TRAFFICKING TO VOTE BEFORE COMPLETING THEIR SENTENCE INCLUDING PAROLE.

Proposition18: AMENDS CALIFORNIA CONSTITUTION TO PERMIT 17-YEAR-OLDS TO VOTE IN PRIMARY AND SPECIAL ELECTIONS IF THEY WILL TURN 18 BY THE NEXT GENERAL ELECTION AND BE OTHERWISE ELIGIBLE TO VOTE. LEGISLATIVE CONSTITUTIONAL AMENDMENT.

The California Constitution currently permits individuals who are at least 18 years old on the date of an election to vote in that election. Increased costs for counties, likely between several hundreds of thousands of dollars and $1 million every two years, to send and process voting materials to eligible registered 17-year-olds

Arguments in Favor:

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Whats on Your Local Ballot? - City News Group, Inc

Stem Cell Banking Market is forecast to reach $6,956 million by 2023 | ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save – The Daily…

The global stem cell banking market was valued at $1,986 million in 2016, and is estimated to reach $6,956 million by 2023, registering a CAGR of 19.5% from 2017 to 2023. Stem cell banking is a process where the stem cell care isolated from different sources such as umbilical cord and bone marrow that is stored and preserved for future use. These cells can be cryo-frozen and stored for decades. Private and public banks are different types of banks available to store stem cells.

Top Companies Covered in this Report: Cord Blood Registry,ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save, New York Cord Blood Program, CordVida, Americord, CryoHoldco, Vita34

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Increase in R&D activities in regards with applications of stem cells and increase in prevalence of fatal chronic diseases majorly drive the growth of the global stem cell banking market. Moreover, the large number of births occurring globally and growth in GDP & disposable income help increase the number of stem cell units stored, which would help fuel the market growth. However, legal and ethical issues related to stem cell collections and high processing & storage cost are projected to hamper the market growth. The initiative taken by organizations and companies to spread awareness in regards with the benefits of stem cells and untapped market in the developing regions help to open new avenues for the growth of stem cell banking market in the near future.

The global stem cell banking market is segmented based on cell type, bank type, service type, utilization, and region. Based on cell type, the market is classified into umbilical cord stem cells, adult stem cells, and embryonic stem cells. Depending on bank type, it is bifurcated into public and private. By service type, it is categorized into collection & transportation, processing, analysis, and storage. By utilization, it is classified into used and unused. Based on region, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

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Table Of Content

CHAPTER 1: INTRODUCTION

CHAPTER 2: EXECUTIVE SUMMARY

CHAPTER 3: MARKET OVERVIEW

CHAPTER 4: STEM CELL BANKING MARKET, BY CELL TYPE

CHAPTER 5: STEM CELL BANKING MARKET, BY BANK TYPE

CHAPTER 6: STEM CELL BANKING MARKET, BY SERVICE TYPE

CHAPTER 7: STEM CELL BANKING MARKET, BY UTILIZATION

CHAPTER 8: STEM CELL BANKING MARKET, BY REGION

CHAPTER 9: COMPANY PROFILES

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Stem Cell Banking Market is forecast to reach $6,956 million by 2023 | ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save - The Daily...

Placenta Is Initiated First, as Cells of a Fertilized Egg Divide and Specialize – Technology Networks

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The first stages of placental development take place days before the embryo starts to form in human pregnancies. The finding highlights the importance of healthy placental development in pregnancy, and could lead to future improvements in fertility treatments such as IVF, and a better understanding of placental-related diseases in pregnancy.

In a study published in the journal Nature, researchers looked at the biological pathways active in human embryos during their first few days of development to understand how cells acquire different fates and functions within the early embryo.*

They observed that shortly after fertilisation as cells start to divide, some cells start to stick together. This triggers a cascade of molecular events that initiate placental development. A subset of cells change shape, or 'polarise', and this drives the change into a placental progenitor cell - the precursor to a specialised placenta cell - that can be distinguished by differences in genes and proteins from other cells in the embryo.

"This study highlights the critical importance of the placenta for healthy human development," said Dr Kathy Niakan, group leader of the Human Embryo and Stem Cell Laboratory at the Francis Crick Institute and Professor of Reproductive Physiology at the University of Cambridge, and senior author of the study.

Niakan added: "If the molecular mechanism we discovered for this first cell decision in humans is not appropriately established, this will have significant negative consequences for the development of the embryo and its ability to successfully implant in the womb."

The team also examined the same developmental pathways in mouse and cow embryos.** They found that while the mechanisms of later stages of development differ between species, the placental progenitor is still the first cell to differentiate.

"We've shown that one of the earliest cell decisions during development is widespread in mammals, and this will help form the basis of future developmental research. Next we must further interrogate these pathways to identify biomarkers and facilitate healthy placental development in people, and also cows or other domestic animals," said Claudia Gerri, lead author of the study and postdoctoral training fellow in the Human Embryo and Stem Cell Laboratory at the Francis Crick Institute.

During IVF, one of the most significant predictors of an embryo implanting in the womb is the appearance of placental progenitor cells under the microscope. If researchers could identify better markers of placental health or find ways to improve it, this could make a difference for people struggling to conceive.

"Understanding the process of early human development in the womb could provide us with insights that may lead to improvements in IVF success rates in the future. It could also allow us to understand early placental dysfunctions that can pose a risk to human health later in pregnancy," said Niakan.

Reference: Gerri C, McCarthy A, Alanis-Lobato G et al. Initiation of a conserved trophectoderm program in human, cow and mouse embryos. Nature. 2020. doi:10.1038/s41586-020-2759-x

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source. *The human embryos examined during this study were in the morula stage of early-development, consisting of around 16-32 cells before progressing into the blastocyst stage (around 200 cells). They had been donated to research with consent by people undergoing in vitro fertilisation (IVF) and were not needed during the course of their treatment. This study was approved by the UK Human Fertilisation and Embryology Authority (HFEA): research licence number R0162, and the Health Research Authority's Research Ethics Committee (Cambridge Central reference number 19/EE/0297). **Cow ovaries were obtained as surplus material from abattoirs and bull sperm was obtained from Genus ABS UK and UK Sire Services. This work was approved by the Ethics Committee at the Royal Veterinary College, and followed all relevant institutional and national guidelines and regulations. Mice were mated under laboratory conditions and mouse fertilised eggs isolated for the purpose of this study. This study was approved by the Animal Ethics Committee and by the UK Home Office licence number 70/8560, and followed all relevant institutional and national guidelines and regulations.

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Placenta Is Initiated First, as Cells of a Fertilized Egg Divide and Specialize - Technology Networks

The COVID-19 Fallout: Cancer Stem Cells Market in 2020 What Does the Year Ahead Hold? – Crypto Daily

The COVID-19 tragedy is expected to create a positive impact on the global cancer stem cells market. The bladder cancer segment is projected to grab major share of the market. The targeted cancerous stem cells segment is projected to observe significant growth. The Asia Pacific region is expected to lead the global market throughout the forecast period. The major players of the market are implementing several strategies to withstand their business amidst this catastrophic situation.

At this moment in time, the whole world is in havoc owing to the abrupt outburst of COVID-19 pandemic. However, this pandemic situation has created a positive impact on the global cancer stem cells market. A latest report published by Research Dive reveals that the global cancer stem cells market is anticipated to gather $1,898.3 billion by 2026, rising at a growth rate of 11.8% from 2019 to 2026. The report segments the global market into application, cancer forms, and region. The report provides comprehensive analysis of the impact of COVID-19 on the key drivers, opportunities, limitations, key segments, and top players of the global market.

Regardless of the outbreak of COVID-19 pandemic, government bodies all over the world are hugely investing on research & development activities to enhance the use of cancer stem cells in the cancer treatments. Additionally, the development of stem cells for stem line banking and developing induced Pluri-Potent Stem Cell (PSC) lines is massively boosting the growth of the cancer stem cells market.

Based on cancer forms, the report categorizes the global cancer stem cells market into brain, breast, bladder, liver, blood, pancreatic, lung, colorectal, and other. The bladder segment is dominating the market ever since 2018 and is predicted to gather $303.9 million by 2026. This segment is expected to grow majorly owing to the rising number of deaths due to bladder cancer, all over the world. According to the U.S. government, bladder cancer is the fifth most occurring cancer among all other types of cancer, and therefore it is optimistically influencing the global market growth throughout the projected period.

Based on application, the report divides the global market into targeted cancerous stem cells and stem cells-cancer therapy. Among these, the targeted cancerous stem cells segment is anticipated to observe significant growth at a CAGR of 13.0% throughout the projected period. As targeted cancerous stem cells have the ability to attract normal cells, they can be used positively to target cancer cells; this factor is greatly boosting the growth of this segment.

Regionally, the report studies the market across North America, Asia-Pacific, Europe, and LAMEA. Among these, the Asia-Pacific region is anticipated to lead the global market by garnering $405.17 million by 2026. This is mostly due to the presence of considerable number of scientists in this region that are involved in R&D activities related to stem cell therapy.

The prominent players in the global cancer stem cells market areMerck KGaA, AbbVie Inc., Irvine Scientific, Stem Cell Technologies Inc., MiltenyiBiotec, Thermo Fisher Scientific Inc., OncoMed Pharmaceuticals, Sino Biological Inc., BioTime Inc., and others.These market players are implementing various tactics to survive during this pandemic situation.

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The COVID-19 Fallout: Cancer Stem Cells Market in 2020 What Does the Year Ahead Hold? - Crypto Daily

Stem Cell Manufacturing Market: Year 2020-2027 New Business Experts Ideas by Merck KGaA, Thermo Fisher Scientific, Inc., Osiris Therapeutics, Inc. -…

A new market study report by The Insight Partners on the Stem Cell Manufacturing Market has been released with reliable information and accurate forecasts for a better understanding of the current and future market scenarios. The report offers an in-depth analysis of the global market, including qualitative and quantitative insights, historical data, and estimated projections about the market size and share in the forecast period. The forecasts mentioned in the report have been acquired by using proven research assumptions and methodologies. Hence, this research study serves as an important depository of the information for every market landscape. The report is segmented on the basis of types, end-users, applications, and regional markets. Some of the key players in the study are Merck KGaA, Thermo Fisher Scientific, Inc., BD, Bio-Rad Laboratories, Inc., Miltenyi Biotec, Pharmicell Co., Ltd, Takara Bio Inc., STEMCELL Technologies Inc., Osiris Therapeutics, Inc., and NuVasive, Inc. among others.

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What is Stem Cell Manufacturing?

Stem cell manufacturing discusses the required technologies that enable the transfer of the current laboratory-based practice of stem cell tissue culture to the clinic environment as therapeutics, while concurrently achieving control, reproducibility, automation, validation, and safety of the process and the product.

The market of stem cell manufacturing is anticipated to grow with a significant rate in the coming years, owing to the factors such as, growing public-private investments and funding in stem cell-based research, rising public awareness regarding the therapeutic potency of stem cell products, development of advanced genomic analysis techniques for quality control during stem cell manufacturing, technological advancements in stem cell manufacturing and preservation, and evolving regulatory frameworks for stem cell therapeutics.

An Overview of the Impact of COVID-19 on this Market:

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Stem Cell Manufacturing Market which would mention How the Covid-19 is Affecting the Stem Cell Manufacturing Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Stem Cell Manufacturing Players to fight Covid-19 Impact.

Stem Cell Manufacturing Market: Regional analysis includes:

The Stem Cell Manufacturing Market segments and Market Data Break Down are illuminated below: By Product (Stem Cell Lines, Instruments, Culture Media, And Consumables)

Application (Research Applications, Clinical Applications, and Cell and Tissue Banking)

End User (Pharmaceutical and Biotechnology Companies, Hospitals and Surgical Centers, Academic Institutes, Research Laboratories, and Cros, Cell Banks, and Tissue Banks)

The research provides answers to the following key questions:

The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the Stem Cell Manufacturing market. Further, the report conducts an intricate examination of drivers and restraints operating in the market. The report also evaluates the trends observed in the parent market, along with the macro-economic indicators, prevailing factors, and market appeal with regard to different segments. The report predicts the influence of different industry aspects on the Stem Cell Manufacturing market segments and regions.

This report strategically examines the micro-markets and sheds light on the impact of technology upgrades on the performance of the Stem Cell Manufacturing market.

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Stem Cell Manufacturing Market: Year 2020-2027 New Business Experts Ideas by Merck KGaA, Thermo Fisher Scientific, Inc., Osiris Therapeutics, Inc. -...