INSIGHTS ON CELL & GENE REGULATORY ISSUES
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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.
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Donor Traceability And Consent As It Relates To Cord Blood
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
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.
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The Synergistic Role Of Drug Safety In Clinical Trial Operations
Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.
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Integrating Quality Processes And Documentation After A Merger
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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5 Areas To Focus Your QRM Strategy - Sterile Drug Products
Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products
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China’s Rising Role On The Global Stage In The Oncology Market
The oncology pharma market has largely been dominated by European and U.S. companies. With the ongoing expansion of the Chinese biopharma sector, innovative oncology drugs will emerge from China and compete on the international market.
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The FDA Modernization Act is Signed Into Law. Now What?
Scientists worldwide celebrated the signing of the FDA Modernization Act into law. Gain expert insights into what to anticipate regarding using New Approach Methods (NAMs) in novel IND submissions.