Cell and Gene Regulatory
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Shifting The Approach: 4 Strategies For ICH E6(R3) Implementation
4/30/2024
In addition to codifying some best practices, R3 suggests sponsors take a proportionate approach to identifying and managing areas of risk.
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Unlocking The Future Of Allogeneic Cell Therapy For Oncology
4/30/2024
Here from experts in the cell and gene therapy space about their shared insights into potential trends driving the future of allogeneic therapies for oncology.
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De-Risk mRNA Regulatory Approvals
4/29/2024
Gain insight into how you can de-risk mRNA regulatory approvals with critical quality attribute characterization and lot release testing.
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Strategies For Ensuring Virus Bank Manufacturing Success
4/29/2024
Learn about the processes and best practices applied at a GMP facility to optimize the production of working virus seed stocks and master virus seed stocks.
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Mass Photometry In GMP-Regulated Environments For Characterization Of AAV
4/25/2024
Learn about tools to optimize your process when characterizing Adeno-associated virus (AAV) samples in GMP-regulated environments.
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The Importance Of Potency Assays
4/25/2024
Hear from Kathryn Golden, the SVP Technical Operations & Cell Manufacturing at bit.bio, as she addresses the importance of potency assays.
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Long-Term Cryopreservation And Storage Of Stem Cells
4/25/2024
How long can you store frozen stem cells? Receive expert advice on the long-term storage and cryopreservation of stem cells and stem-cell derived therapies.
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The Importance Of Freezing And Stability Studies
4/25/2024
In this segment from the Cell & Gene Live digital event Stem-Cell Derived Therapies: From Source To Site, we discuss when to start thinking about freezing and stability studies.
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Donor Traceability And Consent As It Relates To Cord Blood
4/25/2024
Do stem cells derived from umbilical cord blood belong to the mother or the child? How does the FDA view donor traceability when it comes to pooled donor manufacturing?
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Umbilical Cord Blood As A Regulated Source Of Starting Material
4/25/2024
Did you know that umbilical cord blood is an FDA-approved source of starting material for cell therapies? Explore the potential benefits of using cord blood as a starting material for stem cells and stem-cell derived therapies.