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New Technical Paper: QbD Approach for Sterilizing Grade Filters in AAV Applications

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Trending: Consideration of Quality by Design Principles in the Use of Sterilizing Grade Filters for Clarification and Final Sterile Filtration in Adeno-Associated Virus Applications.

Sterilizing grade filtration plays an important role in AAV manufacturing, both for drug substance (DS) as well as final drug product (DP). However, to fulfill regulatory expectations for provision of CMC information, it is recommended that the principles of quality by design (QbD) are considered during the early product development stages of the AAV manufacturing process. Both prior knowledge and experimental data should be used to identify potential critical quality attributes (CQAs). Read More…..

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