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Manufacturing Profess Validation - Consideration for Validation of Autologous Products

Process Validation – it has to happen! Join us to hear regulatory perspectives and real-world examples of considerations specific to autologous products, including both cells and tissues. Are normal donor cells ok to use? What risks are associated with validating your process using cells or...


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Innovating process development for sustainable manufacturing

Optimizing a product through process development is a natural step in translating the therapeutic to the clinic. While this is a critical milestone, many of the processes have not been optimized for larger-scale industrialization. This session will evaluate how industry innovators are...


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Industrializing Clinical Delivery

Life changing therapies are being created and manufacturing systems are constantly evolving. However there also needs to be innovation within the logistical delivery of advanced therapies within the clinical setting. The supply chain is working now but how will it cope when there are tens of...


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Plenary Session – Is Big Pharma Ready For Industrial Scale Cell And Gene Therapy?

Recent successes in the market authorization of cell and gene therapy products has generated tremendous excitement. However. to be successful, the industry now needs to move into a phase of industrialization, where like the car industry it needs the “eureka” moment of standardization that allows...


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Cell, Tissue and Gene Products With Marketing Authorization

Prepared by the ISCT Presidential Task Force on the Use of Unproven and/or Unethical Cell & Gene Therapies. #Commercialization #UnprovenCellularTherapies #MarketAuthorizations #ExternalLink

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Cell, Tissue and Gene Products With Marketing Authorization in 2018 Worldwide

Cell and gene therapies (CGTs) are progressively entering into clinical practice in different parts of the world. The International Society for Cell & Gene Therapy (ISCT), a global scientific society, has been committed since 1992 to supporting and developing knowledge on clinical...

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Outsmarting Commercialization Pain-Points Before They Happen: Best Practices for Fill-Finish, Cryogenic Storage, Handling and Supply Chain Logistics

As cell therapies move closer to commercialization, researchers and developers should be aware of the complexities that will come with higher volume operations. Scale-up predictions of 10-20X are not uncommon and many existing clinical trial processes and procedures cannot scale while...

ISCt Webinar Outsmart Commercialization Pain-Points Before They Happen.mp4

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Challenges and Potential Solutions for Taking Your Cell and Gene Therapy Clinical Program to Japan

Regulatory changes within PMDA supporting Conditional Approval of promising cell and gene therapy (CGT) products in Japan, have led to greater interest in taking CGT clinical programs to Japan for development, partnering and earlier commercialization. In response to these changes, the October 10...


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Vectors for Cell Therapies: Design, Process Development, and Commercialization

The ability of cell therapies to impact disease is broadened when coupled with vector technologies that allow genetic modification or delivery of bioactive molecules. Harnessing such technologies to modify cell behavior requires the choice of a suitable vector, the development of a process to...

Recording (1).mp4

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Partnering in Japan: The Athersys • Healios Story

Favorable regulatory changes came into effect at PMDA in November 2014 which introduced potential for conditional market approval of CGT / RM therapeutic candidates after Phase II clinical development and led to increased interest for partnering in Japan. As a result, ISCT and FIRM formed a...

Recording (3).mp4