Global Cell Therapy Manufacturing Market strategic report provides detailed analysis oftenleading cell therapy companies worldwide, evaluating the strengths of each company, as well as identifying cell therapy products in development, manufacturing strategies, and partnerships. These companies include: ReNeuron, Mesoblast Ltd., Asterias Biotherapeutics, TiGenix NV, Cellectis, Cynata Therapeutics, Cytori Therapeutics, Astellas Pharma (and Subsidiary Ocata Therapeutics), Gamida Cell Ltd. and Pluristem Therapeutics.
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Traditionally, one of the major issues with commercializing cell therapy products has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing.
Furthermore, much of cell therapy manufacturing now involves patient-specific cell therapies, where cells for an individual patient are processed one batch at a time.
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Currently, there are more than 20 cell therapy CDMO’s specializing in manufacturing and clinical trial support for cell therapy companies, including:WuXiPharmaTech (and its subsidiary WuXiAppTec), Lonza Group, PCT (a Caladrius company), MEDINET, Cell and Gene Therapy Catapult, Brammer Bio, KBI Biopharmaceuticals, PharmaCell, Roslin Cell Therapies, apceth Biopharma, and more.
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Additionally, the report identifies cell therapy products that have been reviewed and approved by internationally-recognized regulatory agencies, as well as products brought to market in the U.S. with FDA approval. It also specifies which cell therapies have since been pulled from market, due to factors such as low adoption rates, unsuccessful reimbursement strategies, or high cost of manufacturing.
The report analyses time frames for cell therapy product development, distribution channels, key trends and technologies impacting cell therapy manufacturing, cost control measures, and challenges and considerations affecting with cell therapy manufacturing.
It provides an overview of the regulatory environment affecting cell therapy manufacturing in key countries worldwide, evaluating the importance of the recent FDA guidelines for Human Cell and Tissue-based Products (HCT/Ps) and the 21st Century Cures Act, as well as accelerated pathways for cell therapy approvals in Japan, including the:
- Act on the Safety of Regenerative Medicine (Law No. 85/2013)
- Pharmaceuticals and Medical Device (PMD) Act (Law No. 84/2013)
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Companies Mentioned In this report:- ReNeuron, Mesoblast Ltd., Asterias Biotherapeutics, TiGenix NV, Cellectis, Cynata Therapeutics, Cytori Therapeutics, Astellas Pharma, and Subsidiary Ocata Therapeutics, Gamida Cell Ltd., Pluristem Therapeutics, Organogenesis, Inc. & Novartis AG, Genzyme , MEDIPOST, TiGenix NV, Anterogen, Advanced Tissue Sciences, Vericel, FCB Pharmicell, ChiesiFarmaceutici, NuVasive, GSK, JCR Pharmaceuticals Co. Ltd. (Licensee of Mesoblast Ltd.), MasTHerCell, Acquired by Orgenesis, PCT, a Caladrius Company (Previously Neostem), WuXiPharmaTech, Including Subsidiary WuXiAppTech, Inc., Cell and Gene Therapy Catapult, KBI Biopharma (Acquired Opexa Assets, February 2017), Brammer Bio (Formed through Merger of Brammer Biopharmaceuticals and Florida Biologix), Roslin Cell Therapies, a Subsidiary of Roslin Cells, apceth Biopharm, Cognate Bioservices, Inc., MEDINET Co. Ltd., PharmaCell, B.V., The Clinical Trial Company (TCTC), Miltenyi Bioprocess, the Contract Manufacturing Business of Miltenyi Biotec, Lonza Group, Cell Therapy Manufacturing Unit, Praxis Pharmaceutical, Cellular Therapeutics Ltd. (CTL), CTI Clinical Trial and Consulting, Eufets GmbH, Fraunhofer Gesellschaft, Cellforcure SASU, Molmed S.p.A.
Cell Therapies Mentioned:- Apligraf (Organogenesis, Inc. & Novartis AG), Carticel (Genzyme), Cartistem (MEDIPOST), ChrondoCelect (TiGenix NV), Cupistem (Anterogen), Dermagraft (Advanced Tissue Sciences), Epicel (Vericel), Hearticellgram-AMI (FCB Pharmicell), Holoclar (ChiesiFarmaceutici), Osteocel (NuVasive), Prochymal (Mesoblast), Provenge, Strimvelis (GSK), TEMCELL (JCR Pharmaceuticals Co. Ltd., Licensee of Mesoblast Ltd.)
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