Cell Therapy Manufacturing Current Developments and Future Directions /
This book focuses on the current developments and future perspectives on cell therapies. It includes chapters on new scientific developments, non-scientific challenges, standards development and brief summaries of the state of regulation in certain areas. Taken with its companion volume Advanced Cel...
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| 団体著者: | |
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| その他の著者: | , |
| フォーマット: | 電子媒体 eBook |
| 言語: | 英語 |
| 出版事項: |
Cham :
Springer Nature Switzerland : Imprint: Springer,
2025.
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| 版: | 1st ed. 2025. |
| シリーズ: | Advances in Experimental Medicine and Biology,
1486 |
| 主題: | |
| オンライン･アクセス: | https://doi.org/10.1007/978-3-031-97297-3 |
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目次:
- The development of gene edited cell therapies: challenges and solutions
- Combined advanced therapies: challenges and solutions
- Developing advanced therapies in a challenging patent and legal environment: perspectives on current and future cell therapies
- Developing Ethical perspectives on advanced therapies and future challenges
- Modelling adequate reimbursement for cell therapies
- Facilitating international coordination of manufacturers and regulators
- The future of reference materials for cell therapies
- Experiences Development of ISO standards for cell therapies
- NIST activities in development of standards for cell therapies
- FIRM and Japanese standardization initiative for regenerative medicine
- The industry perspective: ARM SBC and ASTM
- Development of cell therapy regulation: the Japanese experience
- MFDS and Korean regulation
- Australian approaches to regulation
- EU regulatory processes for cell therapy applications
- Canadian cell therapyregs
- Development of cell therapy regulation: the US perspective.