Category Archives: Cell Therapy

Although most adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL) experienced complete remission after treatment with 19-28z chimeric antigen receptor (CAR) T cells, those patients with a low pretreatment disease burden experienced a more durable remission, according to results (abstract CT078) presented at the American Association for Cancer Research (AACR) Annual Meeting 2017, held April 15 in Washington, DC.

Our data suggest that incorporation of 19-28z CAR T cells at the time of minimal residual disease [MRD] following first-line chemotherapy will maximize the durability of CAR T-cell mediated remissions and survival and can potentially spare these high-risk patients from hematopoietic stem cell transplant [HSCT], rather than waiting until they relapse morphologically and then trying CAR T-cell therapy when it is less likely to achieve a durable long-term outcome, said Jae Park, MD, assistant attending physician at Memorial Sloan Kettering Cancer Center, in a press release.

According to Park, survival among adults with relapsed or refractory ALL is extremely poor. In order to develop more effective therapies for these patients, Park and others have developed and tested CD19-specific CAR T-cell therapy. This treatment has demonstrated high initial responses in patients with relapsed B-ALL; however, more data were needed to define clinical characteristics of patients who experience greater durability of response.

In this study, 51 patients received 19-28z CAR T cells. The researchers assessed disease burden by bone marrow biopsy immediately prior to T-cell infusion. Patients were grouped into two cohorts: MRD with less than 5% blasts in bone marrow; and morphologic disease (5% or greater blasts).

The two groups had similar rates of complete remission: 95% for the MRD cohort and 77% for the morphologic cohort.

However, when the researchers analyzed survival by cohort, they found that patients with MRD had significantly improved survival outcomes. The median event-free survival for MRD-negative patients with complete remission was not yet reached compared with 6.3 months for the morphologic group (P = .0005). Similarly, the median overall survival was not yet reached for the MRD group compared with 17 months for the morphologic group (P = .0189).

Subsequent transplant was found to have no effect on survival regardless of the patient cohort.

While more patients and longer follow-up will be needed to adequately address the significance of HSCT, the result of this analysis raises a question as to whether 19-28z CAR therapy can be considered as a definitive, curative therapy rather than a bridge to stem cell transplant, at least in a subset of patients, Park said.

Patients from the MRD cohort fared well in terms of side effects as well, compared with those in the morphologic disease cohort. Two of the major side effects associated with CAR T cells, cytokine release syndrome and neurotoxicity, occurred in 42% and 58% of the patients, respectively, in the morphologic disease cohort, compared with 5% and 15%, respectively, in those from the MRD cohort.

The rest is here:
Low Disease Burden Improved Durability of CAR T-Cell Therapy in B-ALL - Cancer Network

April 02, 2017 10:00 ET | Source: Premier Wellness Group

CAPE CORAL, Fla., April 02, 2017 (GLOBE NEWSWIRE) -- Regenerative cell therapy offers residents a way to reduce pain and support their bodys healing process from auto accident injuries, personal injuries, and sports injuries. Painful acute and chronic injuries can be healed using amniotic stem cells. Patients can experience pain relief without drugs with regenerative cell therapy injections that use the growth factors in amniotic stem cells to stimulate healing. Regenerative cell therapy can allow patients a safe form of pain relief and reduce their reliance on pain medications. Regenerative cell therapy is available as part of a patients individualized treatment program by the medical team at Premier Wellness Group.

Regenerative stem cell therapy offers pain relief for auto accident injuries and personal injuries, such as patients dealing with shoulder pain, knee pain, and back pain. Stem cells are a powerful tool for healing. The specialized cells begin as blank cells in that they can be used to regrow any cell needed. It is possible to regrow new cells, muscle, and tissue without surgery. Uninjured stem cells are injected into a targeted area and develop into needed cells. Stem cell therapy supports the bodys own healing process, allowing patients to benefit from injury management without surgery or painkillers.

Patients do not need to worry about any reactions due to rejection, and the amniotic regenerative stem cell therapy process is the least evasive of other forms of stem cell therapy. Patients need little, if any, downtime and stem cell therapy complements chiropractic treatments, massage therapy, nutritional counseling, and corrective exercises to guide the body back into a state of wellness. Stem cell therapy can reduce inflammation, promote healing, and increase range of motion.

We are pleased to provide patients with a natural form of pain relief and rehabilitation that takes into account the bodys own ability to heal itself, said Dr. Patrick King. Regenerative cell therapy requires no surgery- only injections performed by our physician. Stem cell therapy is safe and most patients require no downtime. We invite residents suffering from pain or trauma due to a car accident injury, sports injury, or personal injury to contact our team to learn more about this advanced therapy for healing and recovery.

Dr. Patrick King, clinic director and owner of Premier Wellness Group, has served the chiropractic and rehabilitation needs of residents of Cape Coral, Fort Myers, and surrounding communities for more than 15 years. Patients have made Premier Wellness Group their destination for drug-free, non-surgical pain relief, and rehabilitation. Services at Premier Wellness Group include regenerative cell therapy, trigger point therapy, corrective exercises, lifestyle recommendations, and chiropractic care.

Call (239) 573-7988 to learn more about Cape Coral regenerative cell therapy for knee and shoulder pain relief, or to schedule an appointment. Visit http://www.mypremierwellnessgroup.com/ for additional details.

Related Articles

View original post here:
Premier Wellness Group Offers Regenerative Cell Therapy for Knee ... - GlobeNewswire (press release)

In one of the famous scenes of American animated sitcom Family Guy, which was aired on January 2008, the main character, Peter Griffin, is seen entering a stem cell research lab with half his body paralyzed, as a result of a stroke, and walking out completely healthy.

Growing a heart on a plate (PR photo)

Imagination plays an important role in dealing with stem cells. Theoretically, cells that, in a lab, can differentiate into any specialized cell present countless options of playing with the human bodyfrom treating any physical medical failure, through preparing a bank of human spare parts, to producing a new race of perfect human beings, completely flawless and immune. That is only in theory, however, at least at this stage. In practice, the possibilities inherent in stem cells are still imaginary, and using them for actual treatment is still very limited.

Torontos skyline is dotted with multi-story buildings, each with a series of elevators that fly visitors within second from the ground floor to the upper floors. The 35th floor of Eaton Centre, a shopping mall and office complex located near Dundas Squarewhich locals say is like Times Square, only a lot less impressiveoverlooks almost all parts of the Ontario provinces capital.

Using stem cells for the sake of humanity (Illustration photo: Shutterstock)

The most fascinating research has to do with cardiology. This is the field in which the ability to imagine a new era in the near future appears most palpable. Its difficult to overstate the complexity of the human heart, which is made up of different types of cells and tissues and is activated through a sequence of electrical pulses. Modern medicine has been unsuccessful so far in creating an industrial alternative for the heart, at least not one that allows a quality of life, while transplant surgery suffers from the risks of transplant rejection and a regular donor shortage. These limitations, in addition to the fact that heart diseases are very common and are one of the leading causes of death around the world, make cardiology a fertile ground for an industry of innovative medicine.

PR photo

One field in which this vision has already become a reality, at least partially, is lung therapy. Stem cell medicine holds a potential in terms of lungs suitable for transplantation, when it comes to improving of the chances that the new body wont reject the organ. The entire process, however, is complicated. Lung transplantation is only possible when the person who agreed to donate his organs in advance is declared brain dead, which makes it possible to harvest the organs before the entire body collapses, and these are pretty specific cases. In addition, in this group only 20 percent of the donated lungs are eventually transplantedas the procedure must be quick, and in most cases doctors dont have sufficient information about the lungs condition and the ability to prepare it for a transplantation which wont be rejected.

PR photo

In the stem-cell therapy labs in Toronto, the future is both present and absent. Most researchers refuse to fall into the press trap and talk about a vision for a better future in which every problem will be treated by injecting stem cells. And although the phrase growing a heart on a plate is occasionally heard, they make sure to clarify that such a situation is still far off. Nevertheless, no one will deny that stem-cell therapy is the medicine of the future.

The combination of medical and technological innovations may have brought humanity to the start of a new era, in which it will be possible to cure the body in an immensely more efficient way than in the past. But even these accomplishments highlight how little we know about the human body and how much more we need to learn and work in order to be able to unlock the full potential hiding deep within our cells.

(Translated and edited by Sandy Livak-Furmanski)

Continued here:
Ynetnews Culture - Stem-cell therapy: The medicine of the future - Ynetnews

About thirty percent of the patients reported full improvement which was maintained over a period of one year.

A stem cells based technique has been established by a team of researchers from Odense University Hospital in Denmark, as a cure for erectile dysfunction.

Erectile dysfunction is a problem being encountered by nearly half of the men between the age groups of 40 and 70 years. High blood pressure, diabetes, cardiovascular diseases, psychological problems are a few causes responsible for this disorder in men.

As a cure, men are often advised medications, injection and penile implants to help solve this problem. But these methods have certain disadvantages. Researchers have been looking into devising a more safe and definite method for addressing this problem.

As part of a new research, man's own fat stem cells were isolated, and injected into the corpus cavernosum area of the penis. About thirty percent of the patients reported full improvement which was maintained over a period of one year.

The researchers are now planning to conduct next round of trial to evaluate the effectiveness and safety of this new technique.

Originally posted here:
Stem cell therapy for restoring erectile function - BSI bureau (press release)

ZURICH Novartis AG on Wednesday said the U.S. Food and Drug Administration (FDA) has agreed to accelerate its review of the Swiss drugmaker's CTL019 therapy for young patients with B-cell acute lymphoblastic leukemia.

The move would keep Novartis on track with the development of its so-called chimeric antigen receptor T cell therapy, or CAR-T, in partnership with University of Pennsylvania researchers.

ZARA FOUNDER TO SPEND $344M ON BREAST CANCER-SCREENING FOR SPANISH HOSPITALS

The therapy involves a patient's own T-cells being altered in the lab to help the immune system find and kill cancer cells before being re-infused into the patient.

Basel-based Novartis' first CAR-T therapy license application with the FDA has put the company in pole position with regulators as it pushes for approval alongside rivals including biotech Kite Pharma Inc that are developing similar therapies.

"With CTL019, Novartis is at the forefront of the science and development of immunocellular therapy as a potential new innovative approach to treating certain cancers where there are limited options," Vas Narasimhan, Novartis head of drug development, said in a statement.

CTL019 will likely cost hundreds of thousands of dollars per patient if approved, and Novartis counts it among drugs it believes will eventually exceed $1 billion in annual sales.

DEVON AND LEAH STILL CELEBRATE TWO YEARS IN REMISSION

In a Phase II study, Novartis said 82 percent of patients infused with CAR-T cells achieved complete remission or complete remission with incomplete blood count recovery at three months after treatment. In December, Novartis estimated that 60 percent of those responders were relapse-free after six months.

The company plans to submit an application for market authorization with the European Medicines Agency (EMA) later this year.

See the original post:
Novartis says US regulator grants speedy review of CAR-T cell therapy - Fox News

All causes of the most common form of liver cancer, hepatocellular carcinoma (HCC), are not yet known, but the risk of getting it is increased by hepatitis B or C, cirrhosis, obesity, diabetes, a buildup of iron in the liver, or a family of toxins called aflatoxins produced by fungi on some types of food. Typical treatments for HCC include radiation, chemotherapy, cryo- or radiofrequency ablation, resection, and liver transplant. Unfortunately, the mortality rate is still quite high, with the American Cancer Society giving a 5-year survival rate for localized liver cancer at 31%.

Hoping to improve primary liver cancer including HCC and metastatic liver cancer therapies, researchers from Japan began studying induced pluripotent stem (iPS) cell-derived immune cells that produced the protein interferon-? (IFN-). IFN- exhibits antiviral effects related to immune response, and two different antitumor activities, the JAK-STAT signaling pathway and p53 protein expression. IFN- has been used for some forms of cancer but problems like rapid inactivation, poor tissue penetration, and toxicity have kept it from being used extensively. To get over that hurdle, Kumamoto University researchers used iPS cell-derived proliferating myelomonocytic (iPS-ML) cells, which they developed in a previous research project. These cells were found to mimic the behavior of tumor associated macrophages (TAMS), which inspired the researchers to develop them as a drug delivery system for IFN- and evaluate the therapeutic effect on liver cancer in a murine model in vivo.

The researchers selected two cancer cell lines that were sensitive to IFN- treatment, one that easily metastasized to the liver after injection into the spleen and the other that produced a viable model after being directly injected into the liver. After injection, mice that tested positive for cancer (~80%) were separated into test and control groups. iPS-ML/IFN- cells were injected two to three times a week for three weeks into the abdomen of the test groups.

Livers with tumors were found to have higher levels of IFN- than those without. This was likely due to iPS-ML/IFN- cells penetrating the fibrous connective tissue capsule surrounding the liver ?serous membrane?and migrating toward intrahepatic cancer sites. The iPS-ML/IFN- cells did not penetrate non-tumorous livers, but rather stayed on the surface of the organ. Furthermore, concentrations of IFN- from 24 to 72 hours after iPS-ML/IFN- injections were found to be high enough to inhibit proliferation or even cause the death of the tumor cells.

Due to differences between species, mouse cells are not adversely affected by human IFN-, meaning that side effects of this treatment are not visible in this model. Fortunately, the researchers are working on a new model with the mouse equivalent of human iPS-ML/IFN, and testing its therapeutic abilities.

"Our recent research into iPS-cell derived, IFN- expressing myeloid cells should be beneficial for many cancer patients," says research leader Dr. Satoru Senju. "If it is determined to be safe for human use, this technology has the potential to slow cancer progression and increase survival rates. At this point, however, we still have much work ahead."

This research may be found in the Journal of Hepato-Biliary-Pancreatic Sciences online.

Story Source:

Materials provided by Kumamoto University. Note: Content may be edited for style and length.

View post:
Interferon-beta producing stem cell-derived immune cell therapy on ... - Science Daily

March 28, 2017 10:55 ET | Source: Research and Markets

Dublin, March 28, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Cell Therapy Manufacturing Market, 2017-2027" report to their offering.

During the course of our study, we identified over 110 organizations that are actively involved in the manufacturing of cell therapies.

The scope of this report primarily includes manufacturing of advanced therapy medicinal products (ATMPs) that involve the use of immune cells such as T-cells, Tregs, dendritic cells, tumor cells and NK cells, and stem cells such as adult stem cells, human embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).

Several players, including cell therapy developers, research institutes, contract manufacturing organizations, and government and non-profit organizations, are playing a critical role in the development and manufacturing of these cell therapies. In fact, a number of these players have made heavy investments to expand their existing capabilities and establish new facilities for cell therapy products in order to meet the increasing demand.

Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums to accelerate the transition of these therapies from laboratories to clinics. It is important to highlight that companies that offer logistics and operational services have developed systems / tools for safer and quicker delivery of therapies from manufacturing sites to patients; this has been identified as one of the key challenges in the overall development process.

Popular examples of approved cell-based therapies include (in order of their year of approval) Carticel, CreaVax-RCC, JACE, ReliNethra, PROVENGE and Prochymal. In addition, over 500 cell-based therapy candidates are currently in different stages of clinical development; these are being evaluated in over 1,000 active clinical studies in various regions across the globe. The growing number of cell therapy candidates, coupled with their rapid progression through the various phases of clinical development, continues to create an increasing demand for facilities that offer manufacturing services for these therapies.

The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industry players as well as academic institutes are significantly contributing to the production of GMP grade cell types. In addition, the market has witnessed the entry of several players that offer novel technology solutions, aimed at improving and upgrading existing cell-based therapies and their manufacturing processes. We have observed that such players have signed multiple partnerships / collaborations with an aim to optimize, scale-up and expand the capabilities for production of cell-based therapies.

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. CELL THERAPY MANUFACTURING: INTRODUCTION 3.1. Context and Background 3.2. Cell-based Therapies: Introduction 3.3. Cell Therapy Manufacturing: An Introduction 3.4. Cell-based Therapies Manufacturing: Key Challenges 3.5. Cell Therapy Manufacturing: Types of Manufacturers 3.6. Cell Therapy Manufacturing: Other Important Considerations 3.7. Cell Therapy Manufacturing: Regulatory Landscape

4. MARKET OVERVIEW 4.1. Chapter Overview 4.2. Cell Therapy Manufacturing: Overall Market Landscape 4.3. Cell Therapy Manufacturing: Role of Logistic Service Providers

5. ROADMAPS: POTENTIAL STRATEGIES TO OVERCOME EXISTING CHALLENGES 5.1. Chapter Overview 5.2. Roadmap for the United States 5.3. Roadmaps for Other Geographies

6. CELL THERAPY MANUFACTURING: IN-HOUSE MANUFACTURERS 6.1. Chapter Overview 6.2. Argos Therapeutics 6.3. Bavarian Nordic 6.4. Cytori Therapeutics 6.5. Juno Therapeutics 6.6. MEDIPOST 6.7. SOTIO (Acquired by PPF Group) 6.8. Stemedica Cell Technologies

7. CELL THERAPY MANUFACTURING: INDUSTRY PLAYERS 7.1. Chapter Overview 7.2. Cell and Gene Therapy Catapult 7.3. CELLforCURE 7.4. Lonza 7.5. PharmaCell 7.6. PCT, a Caladrius Company 7.7. Roslin Cell Therapies 7.8. Waisman Biomanufacturing

8. CELL THERAPY MANUFACTURING: NON-INDUSTRY PLAYERS 8.1. Chapter Overview 8.2. Center for Cell and Gene Therapy, Baylor College of Medicine, US 8.3. Centre for Cell Manufacturing Ireland, National University of Ireland, Ireland 8.4. Clinical Cell and Vaccine Production Facility, University of Pennsylvania, US 8.5. Guy's And St. Thomas' GMP Facility, Guy's Hospital, UK 8.6. Newcastle Cellular Therapies Facility, Newcastle University, UK 8.7. Rayne Cell Therapy Suite, King's College London, UK 8.8. Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre of Regenerative Medicine, UK 8.9. Laboratory of Cell and Gene Medicine, Stanford University, US

9. ROLE OF NON-PROFIT ORGANIZATIONS 9.1. Chapter overview 9.2. Cell Therapy Manufacturing: List of Non-Profit Organizations 9.3. Cell Therapy Manufacturing: International Societies

10. RECENT DEVELOPMENTS 10.1. Chapter Overview 10.2. Collaboration / Agreement Models 10.3. Cell Therapy Manufacturing: List of Collaborations 10.4. Cell Therapy Manufacturing: Partnership Analysis

11. MARKET SIZING AND FORECAST 11.1. Context and Background 11.2. Forecast Methodology 11.3. Cell Therapy Manufacturing Market, 2017-2027 11.4. Cell Therapy Manufacturing Market: Regional View

12. SWOT ANALYSIS

13. CONCLUSION 13.1. A Growing Pipeline of Cell Therapy Products is Likely to Increase the Demand for Manufacturing of Cell-based Therapies 13.2. Stakeholders are Continuously Striving to Overcome Existing Challenges 13.3. Developed Economies have Emerged as Prominent Hubs for Cell Therapy Manufacturing 13.4. Both Industry and Academia have Jointly Led the Initiatives; The Trend is Likely to Persist in the Near Term 13.5. Partnerships / Collaborations have been Widespread and will Continue to act as Key Enablers 13.6. The Manufacturing of Cell-based Therapies is Likely to Become a Multi-billion Dollar Market in the Coming Decade

14. SURVEY ANALYSIS 14.1. Chapter Overview 14.2. Seniority Level of Respondents 14.3. Type of Cell Therapy 14.4. Scale of Operation 14.5. Source of Cells 14.6. Type of Cell Culture System 14.7. Fill / Finish Service

15. INTERVIEW TRANSCRIPTS 15.1. Chapter Overview 15.2. Tim Oldham, CEO, Cell Therapies 15.3. Brian Dattilo, Manager of Business Development, Waisman Biomanufacturing 15.4. Mathilde Girard, Department Leader, Cell Therapy Innovation and Development, YposKesi 15.5. Dr. Gerard J Bos (CEO, CiMaas)

16. APPENDIX: TABULATED DATA

17. APPENDIX: LIST OF COMPANIES AND RESEARCH ORGANIZATIONS

For more information about this report visit http://www.researchandmarkets.com/research/bvlctq/cell_therapy

Related Articles

Go here to read the rest:
Cell Therapy Manufacturing Market, 2027: Partnerships / Collaborations have been Widespread and will Continue to ... - GlobeNewswire (press release)

Results from an eight-subject Phase 1/2 clinical trial, ReaCT, assessing a single injection of Replicel Life Sciences' (OTCQB:REPCF) RCT-01 into the Achilles tendon of patients with Achilles tendinosis showed clinically important improvements including pain sensation, physical function, blood supply and tendon composition.

Achilles tendinosis is a degenerative process of the tendon that does to present with signs like inflammation either clinically or by examining tissue samples under a microscope, but is associated with pain and loss of function. There are no effective therapies for the condition.

Participants showed clinically relevant signs of healing six months after injection as measured by an overall 15.3% improvement in a scale called VISA-A. Two patients achieved almost total recovery. Four of five patients who completed questionnaires showed relevant signs of improvement in pain on loading (running/jumping) based on a scale called VAS. The average improvement in VAS score from baseline was 62.9%. Three of the five patients experienced improvements in pain on palpation (feeling the tendon with the hands during a physical exam). The average improvement in VAS score from baseline was 55.2%.

All study participants except one experienced at least one adverse event, either injection site soreness or observation of a partial thickness tear in the tendon after the injection.

RCT-01 is an autologous cell therapy that uses non-bulbar dermal sheath cells isolated from the hair follicle sheath. Developmentis ongoing.

Here is the original post:
Replicel's cell therapy candidate RCT-01 shows treatment effect in patients with degenerated Achilles tendon - Seeking Alpha

Nohla Therapeutics is tapping the University of California, Davis (UC Davis) for its expertise in cell therapy GMP and manufacturing so that it can scale up clinical trials manufacture of NLA101, Nohla's Phase IIb-stage off-the-shelf universal donor stem and progenitor cell therapy for hematologic cancers. The firm will also work with UC Davis to further optimize the NLA101 manufacturing process, with a view to future commercial production.

Under terms of the collaboration and manufacturing agreement, UC Davis will carry out manufacturing and quality control testing of NLA101 at the UC Davis Institute of Regenerative Cures (IRC) cGMP Cell Therapy Manufacturing Facility in Sacramento, CA. Nohla has sublicensed office and laboratory space at the Oak Park Research Center next to the IRC, which will act as a warehouse and distribution center for supplying the IRC with raw materials and for storing NLA101 for distribution to the clinical trials sites. The collaboration will enable the production of enough NLA101 to supply clinical trials evaluating NLA101 in hematopoietic cell transplant and for treating chemotherapy-induced neutropenia.

This collaboration allows Nohla to capitalize on the expertise at UC Davis to scale manufacturing for NLA101 and increase our ability to supply product for multiple clinical trials, commented Kathleen Fanning, president and CEO at Nohla.

Lars Berglund, M.D., Ph.D., associate vice chancellor for biomedical research and vice dean for research at UC Davis School of Medicine, added, We are particularly excited to partner with Nohla for the development of this groundbreaking technology as it demonstrates our commitment to work with innovative companies developing lifesaving therapies.

Nohla was established in 2015 to exploit technology developed at the Fred Hutchinson Cancer Research Center, which enables the Notch-mediated ex vivo expansion and directed differentiation of cord blood stem and progenitor cells into off-the-shelf universal donor cell therapies that can be used on demand without human leukocyte antigen (HLA) matching in recipients.

The lead product NLA101 has been evaluated in more than 100 patients at high risk of severe infection and other complications after chemotherapy or cord blood transplantation. A Phase IIb study is ongoing in patients undergoing myeloablative cord blood transplant for leukemia and other blood cancers. Nohla is also planning to start a Phase II study in patients undergoing high-dose chemotherapy for acute myelogenous leukemia (AML).

In November 2016, Nohla raised $43.5 million in a Series A financing round, taking total investment in the company to $64.5 million.

See original here:
Nohla and UC Davis Ink Manufacturing Deal for Off-the-Shelf Donor Stem Cell Therapy - Genetic Engineering & Biotechnology News

NEW YORK, March 27, 2017 /PRNewswire/ -- The "Cell Therapy Manufacturing Market, 2017-2027" report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell therapy developers with in-house manufacturing facilities. These therapies are anticipated to emerge as viable alternatives to conventional treatment options.

The scope of this report primarily includes manufacturing of advanced therapy medicinal products (ATMPs) that involve the use of immune cells such as T-cells, Tregs, dendritic cells, tumor cells and NK cells, and stem cells such as adult stem cells, human embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).

Several players, including cell therapy developers, research institutes, contract manufacturing organizations, and government and non-profit organizations, are playing a critical role in the development and manufacturing of these cell therapies. In fact, a number of these players have made heavy investments to expand their existing capabilities and establish new facilities for cell therapy products in order to meet the increasing demand.

Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums to accelerate the transition of these therapies from laboratories to clinics. It is important to highlight that companies that offer logistics and operational services have developed systems / tools for safer and quicker delivery of therapies from manufacturing sites to patients; this has been identified as one of the key challenges in the overall development process.

During the course of our study, we identified over 110 organizations that are actively involved in the manufacturing of cell therapies.

The current status of the market with respect to key players along with information on the location of their manufacturing facilities, scale of production, type of cells manufactured, purpose of production (fulfilling in-house requirements / as a contract service provider) and the type of organization (industry / non-industry).

Most active regions in terms of cell therapy manufacturing with schematic representations of world maps that clearly highlight the global cell therapy manufacturing hubs.

Roadmaps published by different agencies across the globe to provide strategies to advance cell therapy manufacturing.

Elaborate profiles of key players that offer contract manufacturing services (industry and non-industry) or manufacture cell therapies in-house; each profile covers an overview of the company, information on its manufacturing facilities, and recent collaborations.

Partnerships that have taken place in the recent past covering manufacturing and services agreements, agreements specific to technology / instruments / process developments, and mergers and acquisitions.

A discussion on the key enablers of the market and challenges associated with the cell therapy manufacturing process.

Potential future growth of the cell therapy manufacturing market segmented by the type of cell therapy, source of cells (autologous and allogeneic) and purpose of manufacturing (in-house and contract services). For the purposes of our analysis, we took into consideration several parameters that are likely to impact the growth of this market over the next decade; these include the likely increase in number of clinical studies, patient population, anticipated adoption of commercial cell-therapies and expected variation in manufacturing costs.

We have provided an estimate of the size of the market in the short to mid-term and long term for the period 2017 to 2027. The base year for the report is 2016. To account for the uncertainties associated with the development of novel therapeutics and to add robustness to our model, we have provided three forecast scenarios portraying the conservative, base, and optimistic tracks of the market's evolution.

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth.

Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Tim Oldham (CEO, Cell Therapies), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) and Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi), Dr. Gerard J Bos (CEO, CiMaas).

Example Highlights

Overall, we identified over 60 industry players and 50 academic institutes / non-profit organizations that are actively contributing in the field of cell-therapy manufacturing. We came across 68 players that are involved in manufacturing of immunotherapies and 66 players that possess capabilities for manufacturing adult stem cell therapies. Further, 28 organizations have facilities for both immunotherapies and adult stem cell therapies. Within the stem cell therapy market, we identified 15 and 17 organizations that are involved in the manufacturing of ESCs and iPSCs, respectively.

As majority of cell therapy products are in early phase of development, several manufacturers have facilities that meet the clinical scale production requirements. However, some players (31, as per our research) have developed / are developing commercial scale capacity for cell therapy production. Examples include (in alphabetical order) apceth Biopharma, Brammer Bio, Cell and Gene Therapy Catapult, CELLforCURE, Cognate BioServices, EUFETS, Guy's and St Thomas' Facility, Lonza, MaSTherCell, PharmaCell and WuXi AppTec.

Although the current market landscape is dominated by contract manufacturers, some well-established cell therapy developers have set up in-house manufacturing capabilities to support their requirements of cGMP grade cells. Examples include (in alphabetical order) Adaptimmune, Argos Therapeutics, Cell Medica, Cellular Biomedicine Group, Juno Therapeutics, Kite Pharma and SOTIO. In addition, we identified over 10 organizations that manufacture cell-based therapies for their own clinical research as well as offer contract services to other organizations Examples include (in alphabetical order) Amsterdam BioTherapeutics Unit (AmBTU), apceth Biopharma, Children's GMP / GMP facility (St. Jude Children's Research Hospital), Cook Myosite, John Goldmann Centre for Cellular Therapy (Imperial College London), MolMed, and PCT (a Caladrius Company).

North America has the maximum number of cell therapy manufacturing facilities (~ 43%), followed by the EU where ~40% of the global cell therapy manufacturing facilities are located. Specifically, in the EU, maximum number of manufacturing facilities are located in the UK (~44%). Other emerging pockets for cell therapy manufacturing include Australia, China, Japan, Singapore, South Korea and Israel; facilities in these regions primarily cater to the Asia-Pacific markets.

Over 140 collaborations have been inked between cell therapy developers, cell therapy manufacturers and other stakeholders of the industry. The motive behind the partnerships varies; they have been signed for obtaining manufacturing services, gaining access to services related to data management, reagent supply and logistics, upgrading technologies for manufacturing processes, and acquisition of manufacturing facilities.

The near-term demand for manufacturing of cell-based therapies will primarily be driven by clinical candidates. In the longer term, the currently approved therapies and late-stage therapies (that are likely to get commercialized in future) will act as key drivers of the market. Our outlook is highly promising; we expect the market for cell therapy manufacturing to grow at an annualized growth rate of ~42% over the course of next ten years and be worth over USD 4 billion in 2027.

Research MethodologyThe data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:- Annual reports - Investor presentations - SEC filings - Industry databases - News releases from company websites - Government policy documents - Industry analysts' views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

Chapter Outlines

Chapter 2 is an executive summary of the insights captured in our report. The summary offers a high level view on the current state of the cell therapy manufacturing market and its likely evolution over the coming decade.

Chapter 3 provides a general introduction to the cell-based therapies and ATMPs, their classification and definitions. It includes a detailed discussion on manufacturing of cell-based therapies, associated challenges, and application of the currently available for cell therapies. The chapter also provides a detailed description on the regulatory landscape for cell therapies.

Chapter 4 identifies the contract service providers / in-house manufacturers that are actively involved in the manufacturing of ATMPs. It provides details on the ATMP manufacturing capabilities of these organizations, specifically focusing on the type of organization, geographic location of their facilities, scale of operation, type of cells manufactured and the purpose of manufacturing (in-house requirement / third party manufacturing). It contains world maps highlighting the geographical locations of cell therapy manufacturing facilities. Further, it discusses the development trends within the overall cell therapy manufacturing landscape.

Chapter 5 provides details on the roadmaps published by different organizations in various geographies, specifically in the US. These roadmaps describe the strategies that are helpful in accelerating the translation from laboratory to clinics.

Chapter 6 contains detailed profiles of in-house manufacturers. Each profile provides a brief overview of the company, its financial performance, details on manufacturing capabilities and facilities, and the relevant collaborations that have been inked over the last few years.

Chapter 7 contains detailed profiles of key industrial contract manufacturers that have clinical and / or commercial scale manufacturing capacities. Each profile provides a brief overview of the company, details on manufacturing capabilities and facilities, and the relevant collaborations that have been inked over the last few years.

Chapter 8 contains detailed profiles of key academic players that offer contract manufacturing services for cell therapies. Each profile provides a brief overview of the organization, and details on manufacturing capabilities and facilities.

Chapter 9 discusses the role of non-profit organizations in advancing cellular therapies. It provides a list of prominent organizations and profiles of key organizations in different regions. Additionally, the chapter provides information of international / national societies that help in disseminating knowledge about the advancement of these therapies in the community.

Chapter 10 features a comprehensive analysis of the collaborations and partnerships that have been forged between the players in this market. It includes a brief description on the various types of partnership models that are employed by stakeholders in this domain. We have categorized the deals / agreements, which have been captured during our research, into different models and have provided analysis on trend of partnerships over time.

Chapter 11 presents a ten year forecast to highlight the likely growth of the cell therapy manufacturing market. We have segregated the financial opportunity by type of cell therapy (T-cell immunotherapy, cell-based cancer vaccines, stem cell therapies and other ATMPs) and the source of cells (autologous and allogeneic). All our predictions are backed by robust analysis of data procured from both secondary and primary sources. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios.

Chapter 12 provides a SWOT analysis capturing the key elements and factors that are likely to influence the market's future.

Chapter 13 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario and evolutionary trends that are likely to determine the future of this segment of the industry.

Chapter 14 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development of different types of cell therapies. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.

Chapter 15 is a collection of interview transcripts of the discussions held with key stakeholders in the industry.

Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 17 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.

SummaryThe use of live cells for therapeutic purposes can be traced back to 1968, when patients were first successfully treated with allogeneic human hematopoietic stem cell transplants. This practice has now become an integral part of clinical procedures in the space of bone marrow regeneration and organ transplantation. Cell-based therapies are an emerging segment of the overall biopharmaceutical industry.

Post the approval of first cell-based therapy, Carticel, in 1997 in the US, the field has rapidly advanced and a number of such therapies are currently under development. Given the personalized nature of these treatment options, they are highly specific and hold the potential to address unmet medical needs associated with the treatment of several disorders. The promising therapeutic potential has led many pharmaceutical companies and investors to put in a significant amount of capital towards the development and commercialization of these therapies.

Popular examples of approved cell-based therapies include (in order of their year of approval) Carticel, CreaVax-RCC, JACE, ReliNethra, PROVENGE and Prochymal. In addition, over 500 cell-based therapy candidates are currently in different stages of clinical development; these are being evaluated in over 1,000 active clinical studies in various regions across the globe. The growing number of cell therapy candidates, coupled with their rapid progression through the various phases of clinical development, continues to create an increasing demand for facilities that offer manufacturing services for these therapies.

The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industry players as well as academic institutes are significantly contributing to the production of GMP grade cell types. In addition, the market has witnessed the entry of several players that offer novel technology solutions, aimed at improving and upgrading existing cell-based therapies and their manufacturing processes. We have observed that such players have signed multiple partnerships / collaborations with an aim to optimize, scale-up and expand the capabilities for production of cell-based therapies.

Looking at the evolutionary trends, we believe that the cell therapy manufacturing market will continue to be steadily driven in the mid to long term by expansion of existing manufacturing facilities and establishment of new dedicated facilities. Technological advancements to mitigate challenges posed by conventional methods of production will act as a key enabler to this growth.

Read the full report: http://www.reportlinker.com/p04796888-summary/view-report.html

About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. http://www.reportlinker.com

Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cell-therapy-manufacturing-market-2017-2027-300429902.html

See the article here:
Cell Therapy Manufacturing Market, 2017-2027 - Yahoo Finance - Yahoo Finance