Category Archives: Cell Therapy

The Ash conference is usually a mecca for cell therapy followers. Its 2020 instalment features plenty of Car-T and Car-NK presentations, though investors might rue the fact that these risk being overshadowed by antibody modalities.

Clinical data to watch on adoptive cell therapies include those on Fates allogeneic Car-NK project FT596 and Celyads Cyad-02, a Car using short hairpin RNA technology. Meanwhile, Allovir will want to justify enthusiasm for its recent flotation, whileBCMA-targeted multiple myeloma assets fight to stand out from the crowd.

The most advanced anti-BCMA Car-T therapy is Bristol Myers Squibb/Bluebirds ide-cel, which faces a March 27, 2021 US FDA action date despite an earlier refuse-to-file letter. The asset to watch, however, is Johnson & Johnson/Legend Biotechs cilta-cel, whose Cartitude-1 study is showing a remarkable 95% remission rate, according to the Ash abstract.

Not only that, but Bristol/Bluebirds follow-up, bb21217, looks disappointing, Ash data suggest. A US NCI group including Dr James Kochenderfer, who has also worked on ide-cel, is separately presenting clinical results on a new approach, FHVH-BCMA-T, which uses a heavy chain antibody fragment rather than the normal scFv.

With most abstracts citing relatively early data cut-offs, updates at Ash itself will be keenly awaited. Among these Poseida will no doubt field questions if responses to P-BCMA-101 continue to lookbetter at low than at high doses.

Long time coming

First clinical data on FT596, Fates first Car-modified NK cell approach, have been a long time coming: the FDA signed off the IND in September 2019, but the trial did not start until April this year.

Even so there might be disappointment as the Ash abstract details only a single case study, in a lymphoma subject who went into partial response after a single dose. Expectations for FT596 are high given the 73% response rate cited for an unrelated anti-CD19 Car-NK project run by MD Andersons Dr Katy Rezvani.

There might be more on FT596 at Ash, but some analysts are reining in expectations of meaningful data before next year. In the unmodified NK cell sphere, meanwhile, FC21-NK data could support Sanofis decision to buy Kiadis for $358m this month.

Celyad has been working on Car-T cells targeting NKG2D ligands for some time, but Ash will feature the first clinical data on Cyad-02, a construct that aims to improve on an earlier iteration, Cyad-01.

One problem with Cyad-01 is Car-T fratricide, caused by T cells' own transient expression ofNKG2D ligands; Cyad-02 aims to silence these ligands using shRNA technology. The Ash abstract says Cyad-02 showed threefold better expansion than Cyad-01, and promises to deliver preliminary clinical activity data.

While Cyad-02 is an autologous therapy, Celyad is separately developing allogeneic Cars. One of its allogeneic approaches also usesshRNA for gene silencing, so the Cyad-02 data could provide proof of concept beyond the use in the abstract.

Allogeneic therapies will of course be aired extensively at Ash, and a presidential symposium on 8 December will see UCLAs Dr Gay Crooks discussing universal cell sources. Dr Crookss pluripotent stem cell generation technology was licensed to Kite before that company was bought by Gilead.

Other presentations of general interest include a paper suggesting that CD5 knock-out enhances Car-T cell activity, and another claiming that aberrations in CD58 curtail the efficacy of Yescarta. The latter is also being highlighted at a December 5 press briefing, along with preclinical data on Allovirs anti-Covid-19 T-cell therapy ALVR109.

Investors in Allovir, whose stock has doubled since the group raised $318m in a July IPO, will pay close attention.

Ash 2020 will take place in virtual format on December 5-8.

Vantage analysis previously summarised upcoming Ash presentations that resulted in early share price moves, cancer-focused abstracts outside cell therapy, and those in non-oncology indications.

Originally posted here:
Ash 2020 cell therapy preview the battle for recognition - Vantage

By combining machine learning and T-cell engineering researchers were able to develop cell therapies that can selectively and effectively target and destroy solid tumours.

Researchers working to identify anti-cancer therapeutics that can selectively target tumour cells without damaging normal cells have used machine learning and therapeutic cell engineering to develop smart cell therapies for solid tumours.

The research is split across two papers, in the first published in Cell Systems researchers in the lab of Dr Wendell Lim at the University Of California San Francisco (UCSF) Cell Design Initiative and Center for Synthetic Immunology, both US, teamed up with a group of computer scientists led by Dr Olga Troyanskaya at Princeton Universitys Lewis-Sigler Institute for Integrative Genomics and the Simons Foundations Flatiron Institute.

The scientists used computational approaches to examine the gene expression profile of more than 2,300 genes in normal and tumour cells to see what antigens could help discriminate between diseased and healthy cells. They then used machine learning techniques to come up with antigen combinations and determined if they could significantly improve how T cells recognise tumours while ignoring normal tissue.

Following the identification of antigen combinations on the computer, they engineered T cells to target them using a system known as synNotch. synNotch is a customisable molecular sensor that allows synthetic biologists to fine-tune the programming of cells and was developed in the Lim lab in 2016. According to the team it is a receptor that can be engineered to recognise a myriad of target antigens; additionally the response of synNotch to a target antigen can also be programmed, meaning the therapeutic T cell can execute any of a range of responses once an antigen is recognised.

They specifically used synNotch to programme T cells to destroy kidney cancer cells that express a unique combination of antigens called CD70 and AXL. Although CD70 is also found in healthy immune cells, and AXL in healthy lung cells, the engineered T cells killed only the cancer cells and spared the healthy cells.

The field of big data analysis of cancer and the field of cell engineering have both exploded in the last few years, but these advances have not been brought together, said Troyanskaya. The computing capabilities of therapeutic cells combined with machine learning approaches enable actionable use of the increasingly available rich genomic and proteomic data on cancers.

In the second paper, published inScience, Lim and colleagues used their computationally derived protein data to design effective and highly selective cell therapies for cancer.

Currently, most cancer treatments, including cell therapies, are told block this or kill this,' said Lim, also professor and chair of cellular and molecular pharmacology and a member of the UCSF Helen Diller Family Comprehensive Cancer Center. We want to increase the nuance and sophistication of the decisions that a therapeutic cell makes.

The researchers highlighted the example of chimeric antigen receptor (CAR) T cells. In CAR T-cell therapy, T cells are collected from a patient and manipulated in vitro to express a receptor that will recognise a specific antigen on cancer cells. However, despite their success in haematological malignancies like leukaemia and lymphoma, so far, the method has not been as effective in solid tumours. Cells in these cancers often share antigens with normal cells found in other tissues and they also create an immunosuppressive microenvironment; both limit the efficacy of CAR T cells.

Lim said that since solid tumours are more complex than blood cancers, a more complicated product is required to combat them.

In their paper, researchers daisy-chained multiple synNotch receptors together to create a host of complex cancer recognition circuits. The team said that since synNotch can activate the expression of selected genes in a plug and play manner, these components can be linked in different ways to create circuits with diverse functions, allowing for precise recognition of diseased cells and a range of responses when those cells are identified.

This work is essentially a cell engineering manual that provides us with blueprints for how to build different classes of therapeutic T cells that could recognise almost any possible type of combinatorial antigen pattern that could exist on a cancer cell, noted Lim.

The team gives two examples of how this can function:

In the paper the team uses these configurations to selectively kill cells carrying different combinatorial markers of melanoma and breast cancer. They also showed in a murine model of two similar tumours with different antigen combinations, that the T cells efficiently and precisely located and killed the tumour they had been engineered to detect.

Lims group is now exploring how these circuits could be used in CAR T cells to treat glioblastoma.

Related topicsBioengineering, Biologics, Disease research, Drug Development, Drug Targets, Immunooncology, Immunotherapy, Protein, Proteomics, Screening, Therapeutics

Excerpt from:
New 'smart' cell therapies show promise in solid tumours - Drug Target Review

LONDON--(BUSINESS WIRE)--The autologous cell therapy market is poised to grow by USD 1.97 bn during 2020-2024 progressing, at a CAGR of almost 22% during the forecast period.

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The report on the autologous cell therapy market provides a holistic update, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis.

The report offers an up-to-date analysis regarding the current global market scenario, the latest trends and drivers, and the overall market environment. The market is driven by the use of biomass as a fuel in boilers.

The autologous cell therapy market analysis includes the therapy segment, application segment, and geography landscape. This study identifies the increasing demand for effective drugs for cardiac and degenerative disorders as one of the prime reasons driving the autologous cell therapy market growth during the next few years.

This report presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters.

The autologous cell therapy market covers the following areas:

Autologous Cell Therapy Market Sizing

Autologous Cell Therapy Market Forecast

Autologous Cell Therapy Market Analysis

Companies Mentioned

Related Reports on Health Care Include:

Key Topics Covered:

Executive Summary

Market Landscape

Market Sizing

Five Forces Analysis

Market Segmentation by Therapy

Customer landscape

Geographic Landscape

Drivers, Challenges, and Trends

Vendor Landscape

Vendors covered

Appendix

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Autologous Cell Therapy Market 2020-2024- Featuring Bayer AG, Brainstorm Cell Therapeutics Inc., Daiichi Sankyo Co. Ltd., Among Others | Industry...

For over a decade since establishment, Creative Biolabs provides exclusive one-stop services in a systematic manner to global clients to support their RESEARCH on stem cell therapy that has great medical prospects.

New York, USA - November 27, 2020 - Stem cells are non-specialized cells that can be divided into totipotent stem cells, pluripotent stem cells, and multipotent stem cells according to their development level and differentiation ability. In 2006, Shinya Yamanaka discovered the induced pluripotent stem cells (iPSCs) that can eliminate ethical controversy of stem cells and can be generated from the patient's own cells. Creative Biolabs, as a pioneer in the field of biotechnology CRO, masters the frontier technologies and is fully competent to support stem cell research for global customers in the pharmaceutical, medical, and institutional industry.

The services are basically divided into two streams, one for basic research on stem cells and the other for the development of stem cell therapy.

Basic Research

Creative Biolabs supports the fundamental research projects about induced pluripotent stem cell (iPSC) and mesenchymal stem cell (MSC). It is worth mentioning that regarding the newly-developing cell therapy tool-organoid, a variety of platforms have been developed for organ development, including cerebral organoid, gastric organoid, and thyroid organoid, which are developed based upon the featured 3D bioprint technology. Furthermore, the stem cell editing techniques deepen the research on stem cell therapy on a genetic level, covering clustered regularly interspaced short palindromic repeat (CRISPR), transcription activator-like effector nuclease (TALEN), and recombinant DNA technology.

Stem Cell Therapy Development

Creative Biolabs can develop stem cell-based therapeutics that are disease-specific and is capable of providing not only iPSC derived immune cell therapy and iPSC derived stem cell therapy services, but also the stem cell facilitated drug discovery (drug screening, toxicity and efficacy analysis, target identification, etc.).

In addition to the above-mentioned services, Creative Biolabs has established disease models with the exclusive STEMODTM disease model platform to help understand the etiology and progression of diverse diseases involving the cardiovascular system, nervous system, and ocular system.

In recent years, basic and clinical researches of stem cells are under rapid development. To date, more than 3,000 clinical trials involving the use of adult stem cells, and 262 phase III clinical trials and above have been documented at the International Clinical Trials Registry Platform (ICTRP), of which the indications cover neurological diseases, cardiovascular diseases, diabetes, blood diseases, and cancer. However, many challenges still need to be resolved before stem cells can be used in cell therapy. Creative Biolabs can be a reliable partner to support the corresponding research cases.

More details can be found at https://www.creative-biolabs.com/stem-cell-therapy.

About Creative Biolabs

Creative Biolabs keeps pace with the most up-to-date technologies, handling the projects from global customers who are working on the development of novel therapeutics. After years of exploration and accumulation, a comprehensive system of stem cell therapy development has been established, which is operated by a group of P.h.D level scientists. Dozens of successful cases and regular customers prove the strengths of Creative Biolabs.

Media ContactCompany Name: Creative BiolabsContact Person: Candy SwiftEmail: Send EmailPhone: 1-631-619-7922Country: United StatesWebsite: https://www.creative-biolabs.com/stem-cell-therapy

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For Research Only Creative Biolabs Stem Cell Therapy Development Solutions - Press Release - Digital Journal

The Global Stem Cell Therapy Market Report, 2020-25 is a direct informative document containing important data across both historical and current timelines, providing report readers with an innovative understanding of optimizing business discretion for stable revenue generation and global sustainability. The report is carefully contrasted to cover all important aspects of market development in order to continually enhance the vitality of participants and encourage unbiased market decisions amid the fierce competition in the global Stem Cell Therapy Market. Features such as market specific expansion interests and subsequent developments, analysis of market size by value and size, evaluation of additional factors such as drivers, threats, challenges and opportunities are thoroughly relaxed in this illustrative report provided to optimize business discretion

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The report on the global Stem Cell Therapy Market sets up a detailed overview with relevant references to the market dynamics. Extensive references to the market segment organized by market type and application have been extensively discussed in the report. The volume and value-based growth estimates of the market have been detailed in the report. This section of the report has thoroughly covered a close review of market trends, popular events and recent developments. In addition, in the report, readers also provide crucial details on sub-segments to ensure high-end growth.

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COVID-19 Specific Analysis: Global Stem Cell Therapy Market

This sophisticated presentation of the global Stem Cell Therapy Market also includes excerpts from pre- and post-COVID-19 assessments that have made a huge difference in the spectrum of market dynamics. This report is designed to fit the readers preferences and to break away from the downward growth process. In this section, we have scrutinized all the important factors and developments that coincide in the global Stem Cell Therapy Market to enable new investment decisions.

The Stem Cell Therapy Market report is thoroughly structured to include the development of significant milestones in the competitive spectrum, highlighting high-end market players with a thorough guide to their core competencies and investment skills while enhancing competition. The research elements presented in this advanced report have been prepared to ensure smooth decision-making based on thorough and unbiased research practices.

Stem Cell Therapy Market Segmentation

Type Analysis of Stem Cell Therapy Market:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Applications Analysis of Stem Cell Therapy Market:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

Key questions answered in the report:

What are the major developments influencing the global Stem Cell Therapy Market and growth?What is the impact of global Stem Cell Therapy Market development on industry and market participants in the near and far future?What types of global Stem Cell Therapy Market are evolving?What are the evolving applications of the global Stem Cell Therapy Market?What are the key characteristics that will influence the global Stem Cell Therapy Market growth during the study period?Who are the major global players operating in the market?How are the key players using it in the existing global Stem Cell Therapy Market situation?

Key topics covered in this report:

1. Research scope2. Summary3. Stem Cell Therapy Market size by manufacturer4. Regional production5. Consumption by region6. Stem Cell Therapy Market size by type7. Stem Cell Therapy Market size by application8. Manufacturer Profile9. Production forecast10. Consumption forecast11. Upstream, Industry Chain and Downstream Customer Analysis12. Opportunities and challenges, threats and influencers13. Key results14. Appendix

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Stem Cell Therapy Market Size, Growth, Demand, Opportunities & Forecast To 2025 - Cheshire Media

Global Animal Stem Cell Therapy Market

Global Animal Stem Cell Therapy Market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to Global Animal Stem Cell Therapy market.

Global Animal Stem Cell Therapy Market is growing at a High CAGR during the forecast period 2020-2025. The increasing interest of the individuals in this industry is the major reason for the expansion of this market.

Key Market Players: MediVet Biologic, VETSTEM BIOPHARMA, J-ARM, Celavet, Magellan Stem Cells, U.S. Stem Cell, Cells Power Japan, ANIMAL CELL THERAPIES, Animal Care Stem, Cell Therapy Sciences, VetCell Therapeutics, Animacel, Aratana Therapeutics.

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Market Segmentation by Types:

Dogs

Horses

Others

Market Segmentation by Applications:

Veterinary Hospitals

Research Organizations

Additionally, the market report has a devoted segment covering the current market players from the Global Animal Stem Cell Therapy Market. A concise profile section similarly fuses the business system and capital-related information so that capital-related decisions can be recommended to the clients effectively.

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This research report encompasses Global Animal Stem Cell Therapy Market overview, market share, demand and supply ratio, supply chain analysis, and import/export details.

The report has different approaches and procedures endorsed by Key Market players that enable efficient business decisions.

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Global Animal Stem Cell Therapy Market Research Report by Size, Data, Developments, Global Demand, In-Depth Analysis and Forecast 2020 to 2025 |...

Dublin, Nov. 27, 2020 (GLOBE NEWSWIRE) -- The "Gene Therapy - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

In a Major Setback to the Healthcare System, Non-COVID-19 Care Delivery Bears the Brunt of the Pandemic. Gene Therapy Market Slumps by -13.6%

The global market for Gene Therapy is expected to decline by -13.6% in the year 2020 and thereafter recover and grow to reach US$3.3 billion by the year 2027, trailing a post COVID-19 CAGR of 19.5% over the analysis period 2020 through 2027.

Governments worldwide are focusing all healthcare resources on fighting the global pandemic. Billions of dollars have poured into researching COVID-19 drugs, therapies and vaccines. Over US$8 billion globally excluding the U.S. has been pledged only for vaccine development. The U.S. has independently pumped billions of dollars into COVID-19 research and response. The massive reallocation of funds and reprioritization of efforts has left a glaring gap in other sectors of healthcare.

Gene therapy which holds promise for treating cancer, cystic fibrosis, heart disease, diabetes, hemophilia & AIDS, is slumping due to lack of research funds & reduced footfall of patients seeking treatment. Given the complex and fragile manufacturing and delivery system along with funding models of the industry, COVID-19 has emerged as a black swan event. Various players still find it challenging to ensure timely delivery of gene therapy to patients and clinical sites.

There are concerns regarding administration of cell and gene therapies. The chances of virus transmission, mainly to people in the high-risk group, coerced hospitals to delay or cancel appointments. In addition, travel restrictions and stay-at-home orders discouraged patients from visiting to treatment centers. Treatments intended to be delivered into ICUs are being impacted by bed reservations made for patients with COVID-19 infection.

R&D and preclinical activities are also affected by supply shortages as a result of strong demand for consumables like reagents and PPE from COVID-19 laboratories. The clinical development segment suffered the most due to concerns regarding recruitment of patients and suspension of trial enrollments for protecting participants from the risk of infection. These issues are delaying activation of new sites, prompting players to postpone new clinical trials.

However, the intensity of disruptions for cell and gene therapy trials was less in comparison to the pharmaceutical industry due to association of the former with rare and serious medical conditions, enabling participants to continue trials. While companies targeting paediatric diseases suspended trials, others dealing with oncology maintained the pace. COVID-19 has also impacted patient assessment and has made it difficult for companies to perform follow-up evaluations for trial participants. These issues are attributed to confluence of various factors like travel ban, withdrawal of several services from healthcare sites and the risk of virus transmission.

In addition, these disruptions are anticipated to threaten existence of certain cell and gene therapy companies, particularly small-scale biotech players that are in pre-commercial phase and rely on external funding. As governments, stakeholders, pharmaceutical companies and venture capitalists invest in these players on the basis of research milestones, pipeline progress and data readouts, ability of these companies to secure future funding will also be affected.

In the post COVID-19 period, growth will be led by therapy indications in the field of oncology. Gene therapies hold promise to improve the condition of patients where traditional cancer treatments such as radiation and chemotherapy are not effective. Blood and lymphatic cancers hold huge potential as gene therapies can manipulate the genetic information to target the cancerous proteins, thereby enabling the body to fight against the cancers. Oncology will remain the key area of focus for gene therapy applications. Cancer therapies represent the leading category, as is gauged through robust rise in the number of molecules being tested across numerous clinical trials.

Novartis which recently bagged the U.S. FDA approval for Kymriah, a gene therapy designed for the treatment of hematological cancer, is seeking to gain commercial approval in established and emerging countries. Similarly, Kite Pharma, the developer of YESCARTA, the first CAR T-cell therapy approved for certain types of non-Hodgkin lymphoma in adults, has formed a separate team to provide end-to-end support for its Yescarta customers including hospitals and clinics. Such efforts by developers would augment the use case of gene therapies in treatment of large B-cell lymphoma and acute lymphoblastic leukemia (ALL), the high potential cancer treatment verticals.

More developmental focus will also be shed on monogenic rare diseases which have clearer genomic targets and the unmet need in smaller patient populations. Majority gene therapies so far have come to market through accelerated review pathways of regulatory authorities. In the year 2018 alone, over 150 applications for investigational new drugs for gene therapies were filed.

In the coming years, there will be significant improvement in the number of approvals for new gene therapies. The growth is anticipated to emerge from different modalities including RNAi, ASOs and CRISPR gene editing based therapeutics which offer long term opportunities for growth. These technologies are generating much excitement for investors.

Competitors identified in this market include, among others:

Key Topics Covered:

1. MARKET OVERVIEW

2. FOCUS ON SELECT PLAYERS

3. MARKET TRENDS & DRIVERS

4. GLOBAL MARKET PERSPECTIVE

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Global Gene Therapy Market Report 2020-2027: Market is Projected to Reach a Revised $3.3 Billion - GlobeNewswire

NEW YORK, Nov. 25, 2020 /PRNewswire/ -- The Middle East and Africa cell therapy instruments market was valued at US$ 398.23 Million in 2019 and is projected to reach US$ 899.62 Million by 2027; it is expected to grow at a CAGR of 11.0% during the forecast period.

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The surge in the number of cell therapy transplantation procedures, growing research and development activities, and rising investments in building production facilities for cell and gene therapy products drive the growth of the Middle East and Africa cell therapy instruments market. However, the low success rate of cell therapies and the high cost of cell-based research is expected to restrain the market growth during the forecast period.

Cell therapy typically involves the administration of somatic cell preparations by injecting or grafting it into the patient's body for the treatment of diseases or traumatic damages.The procedure is used to cure diabetes, neurological disorders, related injuries, several cancer types, bones and joints, and genetic disorders.

Continuous research and development activities have led to unique cell therapeutic instruments for the improvement of immune system and efficient treatment of genetic disorders.Various market players provide several consumables such as reagent kits and enzymes as well as devices, equipment, and software to perform various cell therapy processes.

The cell therapy products are derived from animals or human cells and thus need to be protected from contamination.The instruments used in cell therapies help provide protection against contamination and allow scaling up of transplantation.

Companies such as Hitachi Chemical Advanced Therapeutics Solutions; Corning Incorporated; Thermo Fisher Scientific Inc.; MiltenyiBiotec, LLC; Invetech; and Cytiva (General Electric Company) have introduced various equipment and consumables for the cell therapy procedures.

Various US-based companies have their manufacturing units in the Middle East and African countries; the lockdown imposed in response to the COVID-19 pandemic in multiple countries has affected the supply of instruments in this region. Therefore, many organizations are collaborating with other companies to overcome the adverse effects of the pandemic by using cell therapies for the treatment of COVID 19.

The Middle East and Africa cell therapy instruments market, by product, is segmented into consumables, software, equipment, and systems.The consumables segment held the largest share of the market in 2019 and is expected to register the highest CAGR during the forecast period.

On the basis of cell type, the cell therapy instruments market is segmented into animal cells and human cells. The human cells segment held a larger share of the market in 2019 and is estimated to register a higher CAGR during the forecast period.

On the basis of process, the Middle East and Africa cell therapy instruments market is segmented into cell processing; cell preservation, distribution, and handling; and process monitoring and quality control.The cell processing segment held the largest share of the market in 2019 and is estimated to register the highest CAGR during the forecast period.

The Middle East and Africa cell therapy instruments market, based on end user, is segmented into life science research companies, research institutes, and other end users. The life science research companies segment accounted for the largest share of the market in 2019 and is anticipated to register the highest CAGR during the forecast period.

A few of the major primary and secondary sources associated with this report on the Middle East and Africa cell therapy instruments market are National Center for Biotechnology Information (NCBI); World Health Organization (WHO); Abu Dhabi Stem Cell Center(ADSCC); South African Stem Cell Institute (SASCI); and Global Institute of Stem Cell Therapy and Research (GIOSTAR).

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Middle East & Africa Cell Therapy Instruments Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Product ; Cell Type ; Process ;...

Cell and gene therapy is booming amid the ongoing pandemic, and this is driving up demand for synthetic DNA products, often produced and delivered by CDMOs.

Karen Fallen started her career at Celltech Biologics in the UK, which was acquired in 1996 by Swiss giant Lonza, a world leader in the pharmaceutical manufacturing space. She stayed there for 31 years before moving on to the role of CEO at Touchlight DNA Services in October.

The market in DNA and nucleic acid medicine is just exploding. Cell and gene therapies have the biggest growth of all the biologics out there and DNA is the essential starting material, Fallen told me.

For several years, UK-based company Touchlight Genetics has been producing a form of synthetic DNA, called doggyboneDNA, that is designed to simplify the manufacturing of DNA vaccines and gene therapy.

To meet the ever-increasing demand for its products, Touchlight Genetics created a contract development and manufacturing organization (CDMO) arm of the business called Touchlight DNA Services, which Fallen now leads.

Traditionally, the DNA necessary for these treatments has been produced by bacteria. Touchlight is developing a method to create this DNA enzymatically, which removes the need to include certain genes required by the bacteria and thus makes the final product simpler and safer.

Its really quick to actually produce the DNA, much faster than the bacterial methodology of doing it, Fallen noted. Its also very scalable.

The increasing need for fast, cheap and accurate DNA synthesis in recent years has led a number of biotechs in Europe to try and meet the demand, such as DNAScript, Evonetix, Nuclera, and Camena Bioscience, among others.

The demand has further increased with the Covid-19 pandemic, since many of the companies developing vaccines or treatments for Covid-19 require DNA as a starting material. So do many tests to diagnose Covid-19 infections.

Theres a lot of potential RNA and [DNA] vaccines out there, Fallen said. The demand for DNA was already outstripping supply, and that was just with cell and gene therapy demands. The Covid-19 impact has just accentuated that.

While CDMOs are crucial to the drug development industry, they often dont receive the same level of public and media attention as biotechs and big pharma. But Fallen thinks their importance is only increasing as cutting-edge treatments become commonplace, as many biotechs working on advanced therapies do not have the capacity for advanced manufacturing.

I think that the CDMO industry over the last few years has really come into its own At least 70% of the innovator molecules out there reside with biotechs that dont always have the capability to develop or manufacture them, Fallen told me.

The supply chain is imperative. Its all very well developing a molecule, but if you cant manufacture it or deliver it, then youre going to go nowhere.

Starting a new job as a CEO is a challenge for most people, but particularly so at the moment with the pandemic hanging over everyone and most people working completely remotely.

I met all the people by Zoom, which isnt often the easiest thing to do. But that gives you an idea of the culture of the company.

Thanks to her experience running a business unit at Lonza, Fallen has learned a lot about how to be a good leader. Ive always found that people follow you because they want to, not because youre in a position of power You need to listen to people, see what motivates them, and then you can get people on board.

Youve also got to make tough decisions quickly as well. You cant have an endless amount of data to make decisions on, youve just got to go with it and have the confidence to do that.

Fallen is a strong believer in supporting others. I have become, surprisingly, even to myself, a role model. I spent a fair amount of time talking with some of the more junior people [at Lonza] mentoring them and giving them my perspective on the world. I have shared what Ive learned as Ive been going along and given some advice on how to handle certain situations.

Although she has been lucky in that respect, Fallen recognizes that diversity can be a problem in CDMOs, biotechs, and pharma companies, particularly at higher management levels.

Youve got to try and get rid of unconscious biases. I know a lot of companies are putting people into positions just to get the numbers up, but Im not convinced thats the right way of doing it. I think you just have to have an open mind and give people the opportunity. From my experience, that is mostly successful.

Youve got to take a risk with people sometimes. Ive been in that position of people taking risks with me. Youve got to then support them, youve got to develop them in the right way, dont just talk them into something. But if you do that, I think you get what you want out of people.

Cover illustration by Elena Resko, picture provided by Touchlight DNA Services.

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CDMOs Are the Unsung Heroes of the Gene and Cell Therapy... - Labiotech.eu

NEW YORK, Nov. 24, 2020 /PRNewswire/ -- The South and Central America cell therapy instruments market is expected to reach US$ 462.05 million in 2027 from US$ 1,074.99 million in 2019. The market is estimated to grow with a CAGR of 11.4% during the forecast period.

Read the full report: https://www.reportlinker.com/p05989607/?utm_source=PRN

The surge in the number of cell therapy transplantation procedures, growing research and development activities, and rising investments in building production facilities for cell and gene therapy products drive the growth of the South and Central America cell therapy instruments market. However, the low success rate of cell therapies and the high cost of cell-based research is expected to restrain the market growth during the forecast period.

Cell therapy typically involves the administration of somatic cell preparations by injecting or grafting it into the patient's body for the treatment of diseases or traumatic damages.The procedure is used to cure diabetes, neurological disorders, related injuries, several cancer types, bones and joints, and genetic disorders.

Continuous research and development activities have led to unique cell therapeutic instruments for the improvement of immune system and efficient treatment of genetic disorders. Various market players provide several consumables such as reagent kits and enzymes as well as devices, equipment, and software to perform various cell therapy processes.

The cell therapy products are derived from animals or human cells and thus need to be protected from contamination.The instruments used in cell therapies help provide protection against contamination and allow scaling up of transplantation.

Companies such as Hitachi Chemical Advanced Therapeutics Solutions; Corning Incorporated; Thermo Fisher Scientific Inc.; MiltenyiBiotec; LLC; Invetech; and Cytiva (General Electric Company) have introduced various equipment and consumables for the cell therapy procedures.

Various US-based companies have their manufacturing units in the South and Central America countries; the lockdown imposed in response to the COVID-19 pandemic in multiple countries has affected the supply of instruments in this region. Therefore, many organizations are collaborating with other companies to overcome the adverse effects of the pandemic by using cell therapies for the treatment of COVID 19.

On the basis of product, the South and Central America cell therapy instruments market is further segmented into consumables, software, equipment, and systems.The consumables segment held the largest share of the market in 2019 and is expected to register the highest CAGR during the forecast period.

On the basis of cell type, the cell therapy instruments market is segmented into animal cells and human cells. The human cells segment held a larger share of the market in 2019 and is estimated to register a higher CAGR during the forecast period.

The South and Central America cell therapy instruments market, based on process, is segmented into cell processing; cell preservation, distribution, and handling; and process monitoring and quality control.The cell processing segment held the larger share of the market in 2019 and is estimated to register the highest CAGR during the forecast period.

Based on enduser, the South and Central America cell therapy instruments market is segmented into life science research companies, research institutes, and other end users. The life science research companies segment grasped the largest share of the market in 2019 and is anticipated to register the highest CAGR during the forecast period.

A few of the major primary and secondary sources referred to while preparing this report on the South and Central America cell therapy instruments market include National Center for Biotechnology Information (NCBI);World Health Organization (WHO); Brazilian Health Regulatory Agency(ANVISA); and Global Institute of Stem Cell Therapy and Research (GIOSTAR).

Read the full report: https://www.reportlinker.com/p05989607/?utm_source=PRN

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The South and Central America cell therapy instruments market is expected to reach US$ 462.05 million in 2027 from US$ 1,074.99 million in 2019 -...