Selecting starting materials and subsequently testing them and process intermediates, along with virus inactivation and removing steps in manufacturing, is a combination approach applied to traditional biopharmaceuticals and advanced therapy medicinal products (ATMPs). However, the complexities surrounding virus inactivation and requirements of using novel cell substrates for manufacturing make finding an appropriate testing plan for ATMPs critical to preserving product safety.
Purification options for ATMPs can be limited due to their delicate nature, but one of the more well-established ones in qPCR. Join us as we explain how qPCR works and how it’s more efficient in identifying a broad range of adventitious agents or residual host cell DNA in cell and gene therapies compared to other methodologies.
Michael Hantman, PhD
Associate Director, Methods Development
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