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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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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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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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Automation in Cell Therapy: A Journey to Next Generation Manufacturing Solutions

To understand how automation can help advance the field of cell & gene therapy, first one should understand what automation is and what its advantages, disadvantages and offerings are to include in planning for successful design and implementation. Automation can come in many different parts...

Recording (4).mp4

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Critical Ancillary Materials for Cell & Gene Therapies: Addressing the Impact of Human Serum and Serum Alternatives

Ancillary materials are critical to the long-term success of your cell and gene therapy product. Critical considerations for ancillary materials of biological origin include sourcing, manufacturing, safety and performance consistency. In this webinar, we will discuss AB serum as a cell media...

ISCT PPD Webinar Recording_10.30.2019.mp4