The Importance of Possessing Good Polymer Chemistry Knowledge in Conducting Extractables/Leachables Studies
Extractables and Leachables studies are an important part of the development cycle of any new drug product. It is important that an appropriate packaging system is chosen such that the product is stable and protected from degradation. It is equally important that this packaging system does not affect the purity of the product by leaching chemicals into the product. Rigorous extractables and leachables testing can ensure the proper packaging system is chosen, and an integral part of this testing regiment includes an extensive knowledge polymer chemistry.
The Importance of Possessing Good Polymer Chemistry Knowledge in Conducting Extractables/Leachables Studies
Extractables and Leachables studies are an important part of the development cycle of any new drug product. It is important that an appropriate packaging system is chosen such that the product is stable and protected from degradation. It is equally important that this packaging system does not affect the purity of the product by leaching chemicals into the product. Rigorous extractables and leachables testing can ensure the proper packaging system is chosen, and an integral part of this testing regiment includes an extensive knowledge polymer chemistry.
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Handling Sterile Potent, Powders Inside a Single Use, Disposable Aseptic Isolator with Martyn Ryder
April 28th 2021During this podcast we shall be discussing how sterile potent powders are becoming more common in the bio-pharmaceutical industry and the challenges around handling these powders in conventional aseptic containment systems. Review the overarching benefits of compliant. single use isolator systems when handling sterile products and how they mitigate the risk associated with potent product batch manufacture.
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March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
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