Stem Cell Clinic

"Cell Therapy Market to Expand Rapidly, Expected to Reach $ 48,115.40 million by 2027, According to Report on – openPR

Cell Therapy Market size, share

It's interesting to note the various types of cells used in cell therapy procedures, including blood and bone marrow cells, mature, immature & solid tissue cells, adult stem cells, and embryonic stem cells. The use of induced pluripotent stem cells (iPSCs), embryonic stem cells (ESCs), neural stem cells (NSCs), and mesenchymal stem cells (MSCs) for transplantation is also noteworthy.

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The application of cell therapy in regenerative medicine is a multidisciplinary area aimed at maintaining, improving, or restoring cell, tissue, or organ function using methods mainly related to cell therapy. The differentiation between autologous cell therapy and non-autologous cell therapy is also important, as it relates to whether the transplanted cells are from the same individual or from a donor. All of these factors are important to consider in the ongoing development and growth of the cell therapy market.

It's unfortunate to hear that the cell therapy market has been negatively impacted by the pandemic. The temporary halting of stem cell therapy and other treatments due to the pandemic-related lockdowns may have significant implications for patients, especially those in need of urgent or life-saving treatments. The delays in clinical trials by biopharmaceutical companies may also have an impact on the development of new cell therapies.

The impact on allogeneic cell therapies or cell therapies derived from a healthy donor is particularly concerning, as these therapies require a supply of healthy donor cells, which may be impacted by the pandemic. It will be important to monitor how the cell therapy market recovers from the pandemic and how the industry adapts to new challenges and changes in the healthcare landscape.

The implementation of effective guidelines for cell therapy manufacturing, as well as the development of advanced genomic analysis techniques, are likely to drive the growth of the market. The vast number of researches being conducted by cancer societies is also a positive development, as it may lead to new cell therapy treatments for cancer and other diseases.

The proven effectiveness of transplants is an important factor as well, as it demonstrates the potential benefits of cell therapy. The transplantation statistics for 2019 in the U.S. provide an indication of the demand for these treatments and the potential impact they can have on patients.

It's also interesting to note that the Asia-Pacific region has high potential for growth in the cell therapy market due to its large population, which can serve as a potential patient base. The growth of healthcare infrastructure and the increase in affordability in developing countries such as India and China is also expected to contribute to the growth of the cell therapy market in these regions. It will be important to monitor how these factors continue to impact the market in the coming years.

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By Cell Type:Stem CellBone MarrowBloodUmbilical Cord-DerivedAdipose-Derived Stem CellOthers (placenta, and nonspecific cells)Non-stem CellBy Therapy Type:AutologousAllogeneicBy Therapeutic Area:MalignanciesMusculoskeletal DisordersAutoimmune DisordersDermatologyOthersBy End User:Hospitals & ClinicsAcademic & Research InstitutesBy Region:North America (U.S., Canada, Mexico)Europe (UK, Germany, France, Spain, Italy, Rest of Europe)Asia-Pacific (Japan, India, China, Australia, Rest of Asia-Pacific)LAMEA (Brazil, Saudi Arabia, South Africa, Rest of LAMEA

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10 Fascinating Early Experiments in Cryogenics – Listverse

If asked about cryogenics, a few things might come to mind. No, that urban legend about Walt Disney being cryogenically frozen is not true. You might also think about the equally fanciful Planet of the Apes, Demolition Man, or Futurama.

Cryogenics (from the Greek words for cold and to generate) refers to the creation of temperatures below what humans normally experience. Besides looking at ways to produce and maintain cold temperatures, cryogenics also involves studying the freezing of materials at cryogenic temperatures. Over the last two centuries, the field of cryogenics has advanced substantially.

So lets take a closer look at ten early experiments in cryogenics.

Related: Top10 Absurd Scientific Experiments And Discoveries

Born in 1797, James Arnott was an English doctor who focused on cryotherapy. Before moving to London, the doctor worked as the senior physician at Englands Brighton Infirmary. Arnott was even the first to utilize extreme cold to destroy tissues. In 1819, Arnott used cryotherapy to freeze breast and uterine tumors while treating cancer patients.

Arnott mixed two parts ice and one part chloride of sodium to make temperatures between -0.4 and -11.2F (-18 and -24C). To perform experiments, Arnott even created his own equipment, which included a waterproof cushion, two flexible tubes to carry water from the impacted area, a reservoir for the mixture, and a sump (a basin to hold wastewater). Arnott performed the first cryosurgery in 1845. Arnott acknowledged the potential cryotherapy had for treating cancer as well as anesthetizing skin before surgery. Today, cryotherapy is still used to treat various types of cancer.[1]

In December 1877, within days of one another, Louis Paul Cailletet (as well as Raoul Pictet) arrived independently at methods to liquefy oxygen.

Cailletet was educated at Lycee Henri IV in Paris and was later employed at his fathers ironworks, where he worked on his studies. In 1869, Cailletet began to experiment with high-pressure chemistry. In December 1877, Pictet announced to the French Academy that he had liquefied oxygen. Two days after Pictet, Cailletet announced he had made the same discovery.

Both men acknowledged that cooling and compression were required to liquefy oxygen but utilized different techniques to do so. Cailletet achieved the liquefaction of gasses through the use of a compression apparatus. Pictet utilized the cascade method, which involved evaporating liquid sulfur dioxide, which turned carbon dioxide into a liquid. Instead of Cailletets method, this produced liquid gas in larger amounts, and its technique could be easier applied to other types of gas. Today, liquid hydrogen and helium play a critical role in cryogenics.[]

Born in Atlantic City in 1922, Irving S. Cooper later received a medical doctorate from the University. He helped to organize the St. Barnabas Hospital Neurosurgery Department in New York City in the 1950s and 1960s. During his employment at St. Barnabas, Cooper became known for performing thousands of operations to help people with movement disorders.

Cooper had a habit of videotaping his patients surgeries. On December 25, 1961, Cooper received a wine bottle opener that lifted corks from bottles by injecting carbon dioxide. What fascinated Cooper was how a portion of the gadget cooled a section of the bottle. Cooper ended up utilizing this bottle-opening technology in surgery.

Patient confidentiality was not what it is today during the 1960s. Consequently, many current experts view Coopers experiments as controversial due to their confidentiality and boundary-pushing nature. Despite these concerns, Cooper created cryosurgery, which involves utilizing liquid gasses to remove diseased tissue.[3]

Wilma Jean McLaughlin almost became the first person cryogenically frozen in 1965 by The Life Extension Society, an organization that offered to freeze a person free of charge at its short-term freezing facility. On May 20, 1965, McLaughlin passed away from heart and circulatory issues. A group of cryogenic scientists attempted to freeze Mclaughlin, but the process failed. Additionally, Juno Incorporated, the company that allegedly supplied the capsule to store McLaughlins body, reported that the device was still being tested and that only a prototype existed.

The experiment that would have seen the freezing of McLaughlin was abandoned. Reports about what exactly prevented McLaughlin from becoming frozen are conflicted. Some reasons cited for why the experiment did not continue include disagreement among McLaughlins relatives and minister about the experiment, the local doctor not helping with the experiment, the hospital administration refusing to help with the experiment, the cryogenic capsule not being prepared, and the minister warning that laws were not in place. At the time of her death, the woman was also not aware that her husband wanted to freeze her.

While technically a failed experiment, McLaughlins situation pushed the Life Extension Society to perform its first cryo-freezing of a human being shortly after.[4]

In the early 1960s, the Cryo-Care Equipment Corporation in Arizona was the only company that did actual cryogenic freezings by utilizing liquid nitrogen. In 1966, the first human body was frozen after having been embalmed for two months.

The process was done by placing the middle-aged womans corpse in liquid nitrogen. The woman was then stored at an above-freezing temperature in a mortuarys refrigerator. The late woman, who was from Los Angeles, was later thawed out a year later and buried by her loved ones.

The same year, the freezing of a San Francisco school teacher was similarly aborted because the man was dead for too long. Researchers decided that even if his brain could later be revived someday, it was damaged beyond repair. [5]

A former University of California-Berkeley professor who passed away from renal cancer in 1967, Bedford was the first human to be cryogenically frozen and stored in the hopes that one day he will be revived.

Bedford used his own money and left $100,000 for cryogenic research when he passed away. Bedfords surviving loved ones ended up spending more than this to defend his will and freezing against other relatives. His body was preserved by several doctors, who injected Bedfords body with a solution of 15% dimethyl sulfoxide and 85% ringers solution. Bedfords brain was likely not protected from these chemicals.

Until 1969, Bedford was stored at Edward Hopes Crypto-Care facility in Phoenix, Arizona. In addition to being a pioneer in cryogenics, Hope was also a wigmaker who kept Bedfords de-animated body in liquid nitrogen. Since 1982, Bedfords corpse has been located at the Alcor Life Extension Foundation in Scottsdale, Arizona. In 1994, concerns about earthquakes, as well as regulatory issues, required Bedford and all 33 frozen corpses where he was stored to be moved to Arizona again. January 12th, the date that Bedford was cryopreserved, is still known as Bedford Day by those in the cryogenics field. [6]

Peter Mazur was a U.S. researcher who created new ways to preserve biological material through crypto preservation, which ultimately allows scientists to store or study biological material over an extended period. Mazurs research during the 1960s and 1970s also led to various discoveries revealing elements that can damage cells during cryopreservation.

Born in New York City in 1928 to a housewife and business writer who lectured at Harvard, Mazur graduated from Harvard University and began experimenting with preserving fungus spores through dehydration. In his landmark paper, A Two-Factor Hypothesis of Freezing Injury: Evidence from Chinese Hamster Tissue-Culture Cells, Mazur found that cell exposure to high salt concentration and ice formation within the cell can lead to cellular damage.

Mazurs work is influential because he determined the optimum cooling rate for each type of cell that is slow enough to prevent freezing but rapid enough to minimize exposure to high salt concentration. Mazurs studies also helped to form the basis for significant advances in cryobiology and cryopreservation.[7]

The Cryonics Society of New York began freezing patients in the late 1960s. Relatives of the subjects paid for the cryo suspensions, while the organization was required to supply storage capsules. In 1972, the company froze its first child, which the Cryonics Society of New York was pleased about due to the publicity associated with the act

In 1972, Genevieve de la Poterie from Montreal became the first cryogenically frozen child. De La Poterie, the daughter of a pharmaceutical salesman and an opera singer, passed away from kidney cancer on January 25, 1972, at eight years old, at Saint Justines Hospital. The California-based Life Extension Foundation was supposed to freeze the childs body. The organization did not do this properly, and the childs body ended up worse off without a chance of being brought back to life. The body was then frozen by the Cryonics Society of New York.

The childs body was stored by the Cryonics Society of California until 1994 when the Chatsworth Disaster occurred. This event saw the failure of the vacuum pump at the location where Nelson kept the bodies. This led to the destruction of many de-animated bodies.[8]

The first human embryo was cryopreserved in 1983. Since this point, cryopreservation of human blood, stem cells, embryos, sperm cells, and oocytes have been involved in over 300,000 births. This initial cryopreservation was performed by a medical research team at Monash University. It was was tasked with reporting on various methods that could be utilized to achieve human pregnancy through in vitro fertilization (IVF) and the freezing of embryos before womb replacement.

In 1971, the program started the research that still underpins IVF today. The study included collecting eggs for research from women volunteers in Melbourne, Australia. In 1973, medical workers in the program achieved the first signs that IVF could be successful in treating infertility issues. In 1938, the Monash team performed another IVF experiment that involved a donated egg cell. Even though this pregnancy ultimately ended in miscarriage at 10 weeks, this experiment served as the basis for additional IVF experiments. Also, in 1983, the program achieved the first IVF births using frozen embryos. This experiment presented evidence that embryos frozen for a time could later be planted into a uterus and turned into a fetus.

In vitro fertilization has gone on to become a treatment method for both men and women who are experiencing infertility. IVF involves the fertilization of an egg cell outside a females body. Medical workers then inseminate the egg with sperm and implant the fertilized egg into the womans uterus. Additionally, Monash IVF is now recognized as one of Australias leaders in fertility programs.[9]

In 1983, Miles, a beagle, participated in a cryonics experiment at the University of California Berkeley. Named after the character that Woody Allen played in Sleeper, the dog had his blood substituted with a glycerol solution. The dog was then cooled to a few degrees above freezing. After spending fifteen minutes in suspended animation, the dog was revived. The researchers later presented details to a meeting of the Federation of American Societies for Experimental Biology in Washington.

Following the experiment, cryonics companies in the United States reported a large increase in the number of inquiries. At the time, scientists hailed this as a substantial step forward in cryogenics.

The Los Angeles Times later published an article clarifying that the dog was not placed at a temperature as low as the freezing level for humans who are cryogenically suspended. The article also noted that the researcher who performed the study was not exactly a Berkeley medical researcher.[10]

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The Rise of Biotech Startups: Advancing Science and Medicine … – Lexology

The COVID-19 pandemic has had a major impact on various industries globally, but the biotech industry has proven to be resilient. Initially, the pandemic caused a setback in the growth and financial stability of the biotech industry, but as the need for scientific breakthroughs, particularly in combating the virus, became more apparent, the biotechnology industry started to recover.

According to a study conducted by McKinsey, venture capitalist (VC) companies increased their investments in biotech startups from 2,200 globally in 2016 to 3,100 by 2021. This highlights the growing importance of investing in science, especially in the biotech industry.

Biotechnology has a wide range of applications that impact our daily lives in many ways. It plays a crucial role in developing food products, using genetically modified organisms, finding sustainable ways of procuring resources, and managing waste. It has the potential to improve our health and that of the planet.

Modern biotechnology has led to several breakthrough products and technologies that aim to reduce our environmental footprint, increase energy efficiency, and promote the use of cleaner energy. It has also contributed to feeding the hungry and enhancing industrial manufacturing processes.

The Biotechnology Revolution

The biotechnology industry has seen remarkable growth and progress over the past few years, with numerous startups making a big impact in different areas of the field. Here are some of the startups that have revolutionized the biotechnology industry:

Cell TherapyCellarity is a startup that has made a significant impact in drug discovery. Their approach involves targeting cell behavior rather than individual proteins. This approach to medicine is based on the understanding of how a disease impacts cell behavior rather than traditional methods of targeting the illness.

NeurologyBionaut Labs is a startup that has revolutionized the treatment of brain disorders through precision-targeted medicine. Their medical method involves the use of remote-controlled micro-robots, known as Bionauts, which have the potential to change the way central nervous system disorders are treated.

Tissue RegenerationEndogena Therapeutics is a clinical-stage biotech company that works on discovering and developing first-in-class endogenous regenerative medicines. Their goal is to repair and regenerate tissues and organs and treat degenerative conditions related to aging and genetic disorders.

Cellular BiologyGinkgo Bioworks believes that biology is the most advanced manufacturing technology on the planet. They aim to program cells to make everything from food to materials to medicine. Their research focuses on modifying microorganisms and they work with several partner companies to develop microbes for different purposes.

Genetic MedicinesPassage Bio is a startup that aims to transform the future through the power of gene therapy. Their R&D model focuses on changing the lives of patients with central nervous system disorders and their goal is to develop a portfolio of five life-transforming AAV-delivered therapeutics.

Gene TherapyKriya Therapeutics is a startup that is revolutionizing the process of how gene therapies are designed, developed, and manufactured. They aim to improve speed to market and reduce costs. Their research targets a wide range of diseases, including obesity and diabetes. Their strong commitment to reducing cost per dose and bringing their products to market faster sets them apart from their competitors.

Tissue RegenerationBiosplices mission is to restore health through first-in-class therapies that harness alternative splicing. The startup is studying ways to manipulate stem cells in order to prevent conditions such as skin diseases, bone and joint ailments, and even hair loss. They are investigating ways to make cells of aging people regenerate as fast as developing embryos do.

Artificial Intelligence in Drug DiscoveryAtomwise is a startup that utilizes artificial intelligence to revolutionize drug discovery. They use deep learning algorithms to analyze large datasets, allowing them to discover new drug candidates faster and more accurately than traditional methods.

Personalized Cancer TherapyNatera is a leading provider of cancer genomics and personalized medicine. Their technology helps to analyze cancer genomic information and personalize patient treatment accordingly. This has the potential to greatly improve patient outcomes and reduce the risk of side effects.

BioprintingOrganovo is a bioprinting company that creates functional human tissues for medical research and therapeutic applications. Their technology has the potential to revolutionize the way we approach disease and injury, as well as reduce the need for animal testing.

Precision AgricultureThe Climate Corporation is a subsidiary of Monsanto that provides farmers with customized data analysis to improve their crop yield and reduce waste. Their technology takes into account a variety of factors, including weather patterns and soil analysis, to provide farmers with the information they need to make informed decisions.

Synthetic BiologyAmyris is a synthetic biology company that uses engineered yeast to produce a variety of compounds, including fuels, fragrances, and personal care products. Their technology is designed to reduce the impact of human activities on the environment, as well as to provide sustainable alternatives to traditional products.

BiomaterialsEcovative Design creates sustainable materials from mushroom roots and agricultural waste. Their materials are being used in a variety of applications, including insulation, furniture, and packaging, and have the potential to greatly reduce the amount of waste generated by traditional materials.

These are just a few examples of the startups that have been instrumental in revolutionizing the biotechnology industry. With continued investment and innovation, it's exciting to see what the future holds for this rapidly growing field.

The Future of Biotech Startups

The biotech industry has seen significant growth in recent years, with increased funding from venture capitalists, partnerships, and IPOs. The amount of venture capital invested in the biotech sector reached $36.6 billion in 2020, with the majority of investments happening in the US, followed by Europe and China. Joint partnerships and ventures reached a total of $170.6 billion in 2020, with a likely much larger undisclosed value.

One reason for the growth of the biotech industry is the increased accessibility and affordability of technology. This, combined with growing investment interest, points to a bright future for the industry.

In addition, the future of biotech startups is expected to be more founder-led. This means that the person who cares most about the research, the founder, will have more control over the direction of the biotech startup. This shift is evident in the recent successful IPOs of biotech startups like Recursion Pharmaceuticals, AbCellera, Ginkgo Bioworks, and SQZ Biotech, which are all led by their creative and scientific founders. This trend is being acknowledged by investors, who are increasingly supportive of companies led by their founders.

Conclusion

The pandemic may have temporarily slowed down the growth of the biotech industry, but the world now recognizes the need for more investment in the field. Biotech startups have made significant contributions to the advancement of science and medicine, bringing new innovations in cell therapy, micro-robotics, tissue regeneration, cellular biology, and genetic medicine.

As the biotech industry continues to grow, we can expect even more groundbreaking innovations in the field. With increased investment from venture capitalists and accessible technology, the future of the biotech industry looks bright. Furthermore, startups in this industry are more likely to be led by their founders, who are driven by a passion for their research and a desire to make a real impact.

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The Rise of Biotech Startups: Advancing Science and Medicine ... - Lexology

The Global Advanced Therapy Medicinal Products CDMO Market … – GlobeNewswire

New York, Feb. 21, 2023 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Advanced Therapy Medicinal Products CDMO Market Size, Share & Industry Trends Analysis Report By Indication, By Product, By Phase, By Regional Outlook and Forecast, 2022 - 2028" - https://www.reportlinker.com/p06422807/?utm_source=GNW Advanced Therapy Medicinal Products (ATMPs) are advanced therapeutic medications that are focused on gene therapy or cell therapy.

CDMOs primarily support their clientele in the process of drug discovery through the provision of manufacturing capabilities and also help the pharmaceutical industry as a whole. The increase in the number of molecular drug approvals, the growing prevalence of infectious diseases, and the growing favorability for innovative therapeutics demand are inducing a rise in the number of CDMO setups in order to facilitate the quick development and production of therapies.

Because of this, the research, knowledge, and manufacturing capabilities of CDMOs are absolutely essential for moving the drug development process forward. Innovative treatments such as somatic cell therapy, gene therapy, and tissue-engineered products are all included in the category of advanced therapy medical products. It is expected that these therapies would deliver significant health advantages.

Medications derived through gene therapy contain genes that have been shown to have a curative, preventative, or diagnostic function. In most cases, they are used to treat a wide range of ailments, such as genetic disorders, cancer, or diseases that have a protracted course of treatment, and they function by introducing recombinant genes into the body. Additionally, a segment of DNA known as a recombinant gene is one that has been synthesized in the lab by combining strands of DNA derived from a variety of different sources.

COVID-19 Impact Analysis

Mesenchymal stem cells (MSCs), an ATMP, also offered a cutting-edge approach to treating the COVID-19 virus. Due to the challenging nature of the manufacturing process, the COVID-19 pandemic has had a substantial impact on the cell and gene therapy sector. Tissue engineering has significantly benefited from recent technology advancements. Damaged organs and tissues can be replaced or have their functionality restored with this technique. Similar to this, cell and gene therapy are attracting a lot of interest from patients in order to treat rare diseases, which are growing globally. Therefore, the pandemic affected the advanced therapy medicinal products CDMO market positively.

Market Growth Factors

Rising Need for CDMOS Due to Increasing Number of ATMP Clinical Trials

The growing number of clinical studies for advanced therapy medicinal products is one of the key factors driving the need for CDMOs. There were 3,579 gene, cell, and RNA therapies in development as of Q1 2022, according to a study by the American Society of Gene and Cell Therapy. According to the research, as of Q1 2021, the pipeline for gene cell therapy has grown by 16%. Genetically engineered cell therapies are being outperformed in the pipeline by CAR-T cell therapies. Furthermore, 98% of CAR-T cell treatments are still being developed for cancer-related indications. All these factors influence an increase in the number of CDMO and thus promote the growth of the advanced therapy medicinal products CDMO market.

Increasing efforts to develop novel therapies for various diseases

The effect of rising product demand around the world is a significant market trend that has prompted the development of novel therapeutic solutions. Over the course of the projection period, increasing product demand and significant increase in gene and cell therapies are anticipated to fuel growth opportunities for the market. CDMO assures the complete solution, starting with the planning of clinical trials and concluding with drug production. While CDMOs can prepare the drug, pharmaceutical and biopharmaceutical companies increase their research to develop innovative and efficient medicines. Therefore, each of these reasons contributes to the expansion of the advanced therapy medicinal products CDMO market.

Market Restraining Factors

Specific drawbacks of cell therapy methods of ATMP

Stem cell therapys primary limitation is that the cells of a single origin can only make cells of the same origin and type, for example, brain cells can only produce more brain cells. This is one of the procedures most significant downsides. The utilization of cell therapies would become more constrained as a result of these drawbacks. Since the use of stem cell therapy can result in the destruction of human embryos, one might expect to see a decline in the demand for these therapies. In addition, it is expected that the risk of contamination and the possibility of technological malfunctions may act as a barrier to the expansion of the automated cell therapy processing systems, which would hamper the growth of the advanced therapy medicinal products CDMO market.

Product Outlook

Based on product, the advanced therapy medicinal products CDMO market is segmented into gene therapy, cell therapy, tissue engineered and others. The cell therapy segment procured a considerable growth rate in the advanced therapy medicinal products CDMO market in 2021. New cell types are continuously being introduced to the domain of cellular therapies, which presents numerous chances for businesses to strengthen their market positions. The significant unmet need for cell therapy production, the recent approval of sophisticated medicines, and the demonstrated efficacy of these products are also drawing new players to the industry. These factors are therefore, propelling the expansion of the segment.

Phase Outlook

On the basis of phase, the advanced therapy medicinal products CDMO market is bifurcated into phase I, phase II, phase III, and phase IV. The phase I segment acquired the largest revenue share in the advanced therapy medicinal products CDMO market in 2021. The segments expansion can be attributed to rising R&D efforts and an increase in the number of advanced therapy human trials. Phase 1 assists in ensuring a drugs safety levels when it is given to a small group of patients in a variety of doses and dosing formats. The major goal of this phase is to ascertain the largest dose a patient may get without experiencing any negative effects.

Indication Outlook

By indication, the advanced therapy medicinal products CDMO market is fragmented into oncology, cardiology, central nervous system & musculoskeletal, infectious disease, dermatology, endocrine, metabolic, genetic, immunology & inflammation, ophthalmology, hematology, gastroenterology, and others. The oncology segment witnessed the maximum revenue share in the advanced therapy medicinal products CDMO market in 2021. The prevalence of the disease, the strategic actions made by key competitors, and the accessibility of cutting-edge medicines utilized to treat various cancer indications are all contributing factors to the segments rise. Oncology clinical trials include all phases of the process where Phase I trials determines dose and phase II analyses define efficacy in a single tumor type.

Regional Outlook

Region wise, the advanced therapy medicinal products CDMO market is analyzed across North America, Europe, Asia Pacific and LAMEA. The North America region recorded the highest revenue share in the advanced therapy medicinal products CDMO market in 2021. This can be due to rising interest in innovative therapies and rising outsourcing activities. The growing burden of diseases like cardiovascular, cancer, and certain rare genetic disorders have raised the levels of research and funding for the development of ATMPs that may serve as treatment methods for these diseases. It is projected that America will maintain its position as a leader in R&D for cutting-edge treatments in the coming years.

The major strategies followed by the market participants are Acquisitions. Based on the Analysis presented in the Cardinal matrix; Thermo Fisher Scientific, Inc. (Patheon, Inc.) and Lonza Group AG are the forerunners in the Advanced Therapy Medicinal Products CDMO Market. Companies such as AGC Biologics, Inc., WuXi Advanced Therapies, and Catalent, Inc. are some of the key innovators in Advanced Therapy Medicinal Products CDMO Market.

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Thermo Fisher Scientific, Inc. (Patheon, Inc.), AGC Biologics, Inc. (AGC, Inc.), Catalent, Inc., Minaris Regenerative Medicine GmbH (Resonac Holdings Corporation), WuXi AppTec Co., Ltd. (WuXi Advanced Therapies), Lonza Group AG, Celonic AG (JRS PHARMA GmbH & Co. KG), Rentschler Biopharma SE, and Bio Elpida (Polyplus-transfection SA.)

Recent Strategies Deployed in Advanced Therapy Medicinal Products CDMO Market

Acquisitions and Mergers:

Aug-2022: Catalent acquired Metrics Contract Services (Metrics), a US-based organization, primarily into providing contract development and manufacturing services for the medical sector. The acquisition advances Catalents ability to better serve its clients, particularly those clients with R & D pipelines having rare, orphan, diseases for oncology and other therapeutic areas.

Apr-2022: Catalent took over Erytechs cell Therapy Development and Manufacturing Facility in Princeton, New Jersey. The 30,900-square-foot manufacturing plants acquisition reflects Catalents devotion to fulfilling the growing demand for cell therapies.

Aug-2021: AGC Biologics acquired a commercial facility in Longmont, Colorado, USA from Novartis Gene Therapies. The acquisition expands AGCs manufacturing capacity supporting its global end-to-end Cell and Gene Therapy (C>) offerings and further expanding cell and gene therapy presence in the US.

Mar-2021: WuXi AppTec acquired OXGENE, a pioneering United Kingdom-based contract research, and development organization. Through this acquisition, the company aims to provide its customers with end-to-end aid in the development and creation of advanced cell and gene therapies.

Jul-2020: AGC took over MolMed, an Italy-based biotechnology company. The acquisition brings in MolMeds expertise and competence in development and GMP manufacturing services to AGC Biologics global CDMO service offerings.

Partnerships, Collaborations and Agreements:

Jan-2023: Catalent came into agreement with Sarepta Therapeutics, a US-based provider of precision genetic medicines. The commercial supply agreement involves Catalent manufacturing Sareptas gene therapy delandistrogene moxeparvovec (SRP-9001) meant for the treatment of Duchenne muscular dystrophy (DMD).

Aug-2022: AGC Biologics partnered with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs). The partnership involves cashing on RoosterBios media and cell products and AGCs gene and cell therapy manufacturing abilities, to develop an end-to-end solution for the production and expansion of exosome and hMSC therapeutics that help media and cell growth services.

Apr-2022: WuXi Advanced Therapies partnered with Bioprocessing Technology Institute, a Singapore-based research institute. The partnership involves accelerating cell and gene therapy products in the APAC region, and focuses on WuXi ATUs Tetracycline-Enabled Self-Silencing Adenovirus (TESSA) technology that enhances adeno-associated virus (AAV) yields and particle quality.

Feb-2021: Rentschler Biopharma SE signed an agreement with Cell and Gene Therapy Catapult (CGT Catapult), an independent center of excellence in innovation advancing the UKs cell and gene therapy industry. The agreement involves leveraging Catapults expertise to set up a manufacturing capability in advanced therapy medicinal products intended for clinical trial supply at Catapults manufacturing facility in Stevenage, England.

Nov-2020: Lonza came into partnership with Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies. Through this partnership, the company aims to offer end-to-end solutions that advance the growth of cell and gene therapies throughout the CGT supply chain.

Feb-2020: Catalent signed a contract with Zumutor Biologics, a US-based biotechnology company, primarily into providing NK cell therapeutics. The agreement involves manufacturing Zumutors ZM008 meant for solid tumor treatment.

Product Launches and Expansions:

May-2020: WuXi Advanced Therapies launched the CAR-T Cell Therapy Platform. A platform intended for advanced therapy companies providing them with various capabilities including, regulatory and technical expertise, full in-process and release testing, robust quality control, etc. The new platform advances the time taken for cell and gene therapy development, at the same time offering greater definiteness.

Jan-2020: WuXi Advanced Therapies unveiled the associated virus (AAV) Vector Suspension Platform. The platform supports advancing the timeline for cell and gene therapy development, at the same time offering greater predictability.

Geographical Expansions:

Oct-2022: Lonza expanded its laboratory space at its facilities in Houston (US) and Geleen (NL). The capacity expansion is intended to expand the CGT process and analytical development. Moreover, the expansion reinforces Lonzas global process development service offerings.

May-2022: AGC Biologics expanded its production capacity at its plant in Colorado, US to cater to the strong demand for cell and gene therapy.

Mar-2021: AGC expanded its geographical footprint by installing new viral vector production equipment at its facility in Milan, Italy. The new equipment would allow AGC to implement a platform best suited for the large-scale manufacturing of viral vectors.

Scope of the Study

Market Segments covered in the Report:

By Indication

Oncology

Cardiology

Central Nervous System & Musculoskeletal

Infectious Disease

Dermatology

Endocrine, Metabolic, Genetic

Immunology & Inflammation

Ophthalmology

Hematology

Gastroenterology

Others

By Product

Gene Therapy

Cell Therapy

Tissue Engineered & Others

By Phase

Phase I

Phase II

Phase III

Phase IV

By Geography

North America

o US

o Canada

o Mexico

o Rest of North America

Europe

o Germany

o UK

o France

o Russia

o Spain

o Italy

o Rest of Europe

Asia Pacific

o China

o Japan

o India

o South Korea

o Singapore

o Malaysia

o Rest of Asia Pacific

LAMEA

o Brazil

o Argentina

o UAE

o Saudi Arabia

o South Africa

o Nigeria

o Rest of LAMEA

Companies Profiled

Thermo Fisher Scientific, Inc. (Patheon, Inc.)

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The Global Advanced Therapy Medicinal Products CDMO Market ... - GlobeNewswire

CRISPR Therapeutics vs Editas Medicine – Securities.io

Gene Editing Hype

Gene editing has for a while been hailed as the new frontier in medicine. The peak enthusiasm with investors on this topic was in early 2020, with the related stocks having cooled off since. No matter the market sentiment, gene editing is still a big deal for medical and pharmaceutical companies as well as patients and doctors.

Gene editing is the next step after gene therapies. Gene therapies add a healthy gene to the genome but leave in place the defective gene. Editing in contrast actually repairs the faulty gene.

Two of the leading firms in the sector are CRISPR Therapeutics and Editas Medicine.

Which one, if any, should you pick as an investment?

Many diseases are due to defective genes, leading to non-functional organs or biochemical processes. They are very often difficult to cure diseases. Infectious diseases can be solved by killing pathogens. Other problems can be solved through surgery or drugs. But when the point of failure is in every cell and requires the body to be changed at the DNA level, this is a lot harder.

For a long time, it was believed that the only solution was gene editing at the early embryo stage, to solve the problem when there is only one cell or at most a few hundred stem cells. And even then, inserting a new, functional gene in defective cells was tricky and prone to failure, as the random entry of the new gene could damage other parts of the genome.

This was until the CRISPR-Cas9 system was discovered. It can be used to target a specific place in the genome. And then to do almost anything molecular biologists want, from knocking-out a gene, entirely deleting it, or also editing it. It can also insert in a controlled fashion entirely new genetic sequences.

This changed everything. Previous methods were too crude to be efficient or safe for most patients. CRISPR brings molecular biology to the next level, allowing precise and in-vivo gene editing to become repeatable and predictable.

Beyond CRISPR-Cas9, researchers have also discovered CRISPR-Cas12. It has slightly different characteristics that might prove better in some cases, like editing multiple genes at once. Or for cell types that do not tolerate Cas-9 well.

While CRISPR Therapeutics favors Cas9, Editas Medicine favors a version of Cas12. If you are technically minded and want to learn more about the difference between the 2 CRISPR systems, I recommend reading this scientific publicationand this article.

The company was founded in 2013 under the name Inception Genomics and went public in 2016.

One of the founders of CRISPR Therapeutics is Emmanuel Charpentier, the discoverer of CRISPR-Cas9 and the Nobel prize of Chemistry in 2020 for that discovery. So it is safe to assume that the company has a crack team when it comes to the scientific side of CRISPR-based gene editing.

Its technology is based on CRISPR-Cas9, allowing for the edition of precisely targeted sections of the genome.

Editas Medicine was founded in 2013 and went public in 2016. It initially started working with Cas9 but is now focused on a proprietary version of Cas12 that they engineered: AsCas12a.

We have covered in detail the unique capacities of Cas-12a in a dedicated article. To resume it shortly:

CRISPR Therapeutics has made the most progress on 2 diseases, Beta-thalassemia and sickle cell diseases (SCD).

This uses an ex-vivo technique: stem cells from the patients are collected, modified/repaired with CRISPR-Cas9, and reintroduced in the body.

Both are under clinical trials in collaboration with Vertex. In June 2022, results from a clinical trial revealedthat 42/44 patients with thalassemia were free from the need for blood transfusion, with the 2 others requiring a lot less blood transfusion.

No serious adverse event was found in SCD patients. Two thalassemia patients had serious adverse events, which have since been healed.

Overall, the blood therapies using CRISPR-Cas9 seem to be a success, and the safety profile acceptable considering how life-threatening and difficult to live with are the diseases treated. You can learn more about the experience of the cured patientin this podcast interviewing one of the participants in the trial.

Another application of CRISPR Therapeutics technology is cancer treatment. The idea is to use modified immune system cells to attack cancer cells. Until now, cells from the patient had to be genetically modified, which took several weeks, which often can be too late for a patients quickly degrading health.

Instead, the company is developing a modified cell that can be manufactured in advance and fit all patients. The method to target the cancer cell is not new, but the possibility to start treatment immediately is. The option to produce a batch of products for hundreds of patients at once is also precious, as it can reduce the complexity and costs of this therapy.

The company has currently 8 candidates in the pipeline, of which 2 already in clinical trials.

CRISPR Therapeutics is also collaborated with the company ViaCyte to improve its product. ViaCyte is aiming to cure type-1 diabetes. This is a disease affecting 8 million peopleand requiring lifelong treatment with insulin.

The issue with ViaCytes current design is that it requires a lifetime of immuno-suppression treatments, which come with their own set of risks and issues. This in turn drastically reduced the size of ViaCytes market.

With the help of CRISPR, ViaCyte is aiming at turning its solution into a lifelong cure for all type-1 diabetes.

Promisingly, the same idea could be used for many other diseases where a specific type of cell needs to be replaced. This could include type-2 diabetes, affecting more than 6% of the worlds population, as well as hepatitis, cirrhosis, or other degenerative diseases.

Each of these 3 applications uses the ex-vivo approach of modifying cells in a lab and re-injecting them in the patients. This is not possible for some diseases, for example, muscular or pulmonary diseases. So CRISPR Therapeutics is also trying to modify the cells of the patients directly in the body, with so-called in-vivo techniques. This either uses viruses as vectors of mRNA techniques not dissimilar to mRNA vaccines.

This is targeting a wide array of diseases including muscular dystrophia and cystic fibrosis (both in partnership with Regeneron), hemophilia (in partnership with Bayer), and cardiac diseases.

In the long run, CRISPR Therapeutics expect the in-vivo technology to become their flagship product and the center of their commercial strategy, able to solve 90% of the most prevalent severe monogenic diseases (see page 35)

Overall, CRISPR therapeutic has done a lot of progress.

It is currently applying for commercialization of its blood therapy products which could concern as many as 30,000 patients in the US and EU. Approval is never a sure thing, but published data last summer of 2022 indicates life-changing efficiency and an acceptable safety profile. Likely, the product could be approved for severe cases at least. This should prove a strong catalyst for the stock as it would be the first product approval for CRISPR Therapeutic.

Further improvement could grow this market to 166,000 patients, or even 450,000 if the in-vivo method proves successful(see the linked presentation page 8).

The cancer treatment trials are still in the early stages, so impossible to predict the outcome. Preliminary data have been encouraging.

The diabetes treatments entered trial on 2ndFebruary 2022. So it is too soon to judge it, but results from this trial could be another strong catalyst for the stock in 2023.

Editas Medicine was previously working, through its EDIT-101 treatment, on curing blindness due to Leber congenital amaurosis 10. The phase 1/2 clinical trial went well, demonstrating the proof of concept.

However, Editas is now looking to license out its technology for this disease, and focus exclusively on its blood disease treatment. It seems the strategic reorientation is due to:

Editas is now focusing on Sickle Cell Disease (SCD), hence going into direct competition with CRISPR Therapeutics own gene editing treatment for SCD.

Editas strategy is counting on the engineered AsCas12a CRISPR system, delivering a superior editing efficiency and specificity than its competitors system using Cas9.

The company is using ASCas12a to activate the genes of ftal hemoglobin in adults, producing functional ftal hemoglobin to replace the one not working in cases of SCD.

The company have also programs at an early stage in oncology (cancer) in partnership with BMS and Immatics. Other organs are also researched, likely for in-vivo therapies. Little has been disclosed about these programs so far.

The initial trial for SCD treatment on 2 patients has shown a good safety profile in the results published on December 2022. The initial results are also demonstrating the proof of concept of the treatment, having increased significantly the hemoglobin levels in the patients blood and reduced or removed symptoms of the disease. Data from additional patients should be published in mid-2023.

The next step is including 40 patients in a clinical trial at phase 1/2, with the first results expected by the end of 2023.

CRISPR Therapeutics valuation in early 2023 has shrunk significantly from a peak of $13.7B in January 2021.

As the company does not have a commercialized product yet, it is reliant on its cash balance and deals with larger pharmaceutical companies.

For example, it register $912M of revenue from its collaboration with Vertex in 2021. This can be compared to $438M in R&D spending and $102M in general administrative spending in the same year. With only 500 employees, the company seems rather lean, efficient, and focused on innovation.

The company has approximately $2B in cash, which should cover the companys needs up to 2024. It has no significant debt or liabilities beyond current operational liabilities and leases for its manufacturing facilities.

Overall, the company finances are sounds, even if it might need to raise more money at one point if its sickle cell disease and thalassemia drugs are not quickly approved. In that respect, the elevated share price of 2021 should have been better utilized to raise funds than risking the current lower valuation.

Like most biotech companies, Editas Medicines valuation is quite lower than its peak at $5.6B in January 2021.

When it comes to the maturity of its portfolio, Editas is just launching now the 40+ patient trials that CRISPR Therapeutics has already finished. So it is likely lagging 1-2 years behind when discussing possible commercialization.

The company has been losing $193M in 2021, of which $142M was spent on R&D. As it currently has $507M in current assets, its liquidity is sufficient for the whole of 2023, even taking into account the extra cost of the incoming clinical trial.

Editas Medicine might need extra funding before reaching commercialization, but this will likely not be the cause of a serious dilution of shareholders, thanks to the solid current cash position. It issued shares worth $203M in 2020 and $249M in 2021, making good use of the then-higher share prices.

Overall, Editas Medicine is at an earlier stage than CRISPR Therapeutics. But thanks to its focused approach centered on only one treatment and disease, it has a similar risk profile when it comes to cash balance and risk of dilution.

CRISPR Therapeutics isthe leader of the sector, benefiting from its first mover advantage, having been founded by the discoverer of Cas9 technology. It also has a much wider portfolio, covering SCD but also another blood disease, cancer, and even diabetes. So its overall potential addressable market is much wider.

It is also more advanced in its clinical trial, having a realistic chance to see at least one product commercialized in a 12-24 months time frame.

Where CRISPR Therapeutics might be lacking, is in its reliance on Cas9 technology, which might be better understood, but slightly less efficient in the long run. It is difficult to judge if these technical differences will result in practical differences in therapeutic efficiency.

Editas Medicine is a trailblazer in turning Cas12a into a practical medical tool. By concentrating its effort on SCD, it is directly targeting CRISPR Therapeutics own SCD treatment. So a lot of the future success or failure of Editas will depend if its treatment for SCD proves superior to CRISPR Therapeutics.

Both company valuations can be considered somewhat equivalent, as CRISPR Therapeutics has a much higher valuation, but also a much more diverse pipeline. Especially as both share a similar risk profile with a large cash cushion enough to cover the next 1-2 years of spending.

It is also possible that both companies will reach commercialization, and share the SCD market on relatively equal terms.

For investors looking at a very innovative and focused company, Editas Medicine might be a favored choice.

For investors looking at a more spread R&D risk, CRISPR Therapeutics wider pipeline should prove more reassuring. The upside in the 4-6 years timeframe of CRISPR Therapeutics might be also larger, thanks to its venture into the very large diabetes market.

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CRISPR Therapeutics vs Editas Medicine - Securities.io

Embryonic Stem Cells – The Definitive Guide | Biology Dictionary

Adult stem cells maintain and repair tissues throughout the body

Embryonic stem cells are pluripotent cells derived from a 3 5 day old human embryo. They have the unique potential to develop into any of the other 200+ human cell types, and can significantly further our understanding of human development and diseases.

Embryonic stem cells also have important applications in drug development, and may one day be used to treat currently incurable conditions.

Stem cells are cells that have the potential to differentiate and give rise to other types of body cells. They are the basic materials from which all of the bodys specialized cells are made during whole-body development and, in adulthood, are used to maintain and repair body tissues. There are two types of human stem cells, and these are embryonic stem cells and adult stem cells.

Embryonic stem cells (ESCs) are stem cells derived from a 3 5 day old human embryo (AKA a blastocyst). ESCs are pluripotent, meaning they have the potential to become any of the other 200+ types of cells found in the human body. As the embryo develops, ESCs divide and differentiate to form the full complement of human body cells required for healthy function.

The first differentiation event in human embryos begins around 5 days after fertilization, so ESCs must be harvested before this time if they are to be used in medicine and research. At this early developmental stage, the cells of the embryo form an undifferentiated mass and have not yet taken on the characteristics or functions of specialized adult cells.

The ability of ESCs to develop into all other types of human cells makes them an invaluable research tool. Studies involving ESCs can advance our understanding of human development, disease treatment, and drug efficacy.

ESCs can be grown (or cultured) in a laboratory. When kept under the right conditions, stem cells will grow and divide indefinitely, without becoming differentiated. However, they will still maintain their ability to differentiate, making the ESC culture a convenient and renewable reservoir of human cells. When used in research, ECSs are converted into their desired cell types by manipulating the culture conditions.

Scientists can use stem cells to further their understanding of human development and diseases. By studying embryonic stem cells, researchers hope to learn how they differentiate to form tissues and organs, how diseases and conditions develop in these tissues, and how age affects their function.

Scientists can also use ESCs to test and develop new drugs and to help them identify new potential treatments for diseases like Parkinsons disease, heart failure, and spinal cord injuries.

ESCs have enormous potential in the development of restorative or regenerative medicine, in which damaged tissues are replaced by healthy ones. Currently, several stem cell therapies are possible and could be used to treat a variety of injuries and diseases. These include spinal cord injuries, retinal and macular degeneration, heart failure, type 1 diabetes, and tendon rupture.

However, research into the use of ESCs for regenerative medicine are ongoing, and better understanding is required before modern medicine can harness their full potential. In the future, scientists hope that stem cell therapies can be used to treat currently incurable or difficult to treat conditions, such as AIDS or certain types of cancer.

Currently, the most common stem cell therapy is multipotent hematopoietic stem cell (HSC) transplantation. This treatment involves the transplantation of hematopoietic (or blood) stem cells and is usually used to treat diseases affecting the blood cells, such as leukemia and anemia.

ESCs can also be used in the development of new drugs, which must be tested on living tissues to determine their efficacy and any possible side effects.

Stem cells cultured in the laboratory can be stimulated to differentiate into any type of human tissue, so they are commonly used in preclinical drug trials. Once the potential and risks of the new drug have been determined using stem cells, the treatment can be used in animal tests and, eventually, human clinical trials.

The discovery of ESCs has led to numerous breakthroughs in the field of medical research, and their potential as the basis for new therapies and drugs is enormous. However, there is ethical controversy surrounding the use of ESCs in research, primarily because harvesting these cells involves destroying a human embryo.

For those who believe that life begins at conception, this raises moral objections. Opponents of stem cell research believe that embryos have the same rights as any other human beings, and shouldnt be disposed of in the name of science.

Those who support the use of ESCs in medical research may argue that the embryos do not yet qualify as humans, as they are destroyed in the very early stages of development. ESCs are harvested at around day 5 of development when the embryo (or blastocyst) is nothing more than a mass of undifferentiated cells.

Embryos used as a source of ESCs are frequently obtained from IVF clinics, where they have been frozen following fertilization. Guidelines created by the National Institute of Health state that embryos can only be used for this purpose when they are no longer needed (meaning they will never be implanted in a womans uterus). Such embryos would eventually be discarded anyway, so it can be argued that they would be better used to advance medical research.

Adult stem cells (AKA somatic stem cells) are stem cells that are found in most adult tissues.

They can develop into other types of cells but, unlike, ESCs, they are not pluripotent (able to develop into any other type of cell). Adult stem cells are either multipotent (able to develop into a limited number of closely related cells) or unipotent (able to develop into just one type of cell).

Their main function is to maintain and repair the tissue in which they are found and to replace cells that die as a result of injury or disease.

Mesenchymal stem cells are found in many adult tissues, including the umbilical cord, bone marrow, and fat tissue. In the bone marrow, mesenchymal stem cells differentiate to form bone, cartilage, and fat cells.

Neural stem cells are found in the brain and develop into nerve cells and their supporting cells (glial cells).

Hematopoietic stem cells are found in the bone marrow and peripheral blood. They give rise to all kinds of blood cells, including red blood cells, white blood cells, and platelets.

Skin stem cells are found in the basal layer of the epidermis and form keratinocytes for the continuous regeneration of the epidermal layers.

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Embryonic Stem Cells - The Definitive Guide | Biology Dictionary