INSIGHTS ON CELL & GENE REGULATORY ISSUES
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New Initiative Seeks To Back Up ICH's Harmonization Mission
An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.
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Process Liquids And Buffers Offering
Whether you are a researcher, scientist, or industry professional, this video will provide valuable insights into our large volume liquids manufacturing capabilities.
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Shifting The Approach: 4 Strategies For ICH E6(R3) Implementation
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
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
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
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
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
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
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
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.