Addressing regulatory guidance for HEK293 cells and AAV-based therapeutics manufacturing

Characterization of a biological product’s identity and potency via analytical assays is necessary to allow for relevant specifications to be established. However, there are a number of regulatory hurdles associated with the development and validation of these analytical assays. This poster will summarize some of the most recent regulations concerning analytical methods to characterize the properties of a biological product. A range of regulatory-validated solutions to overcome these obstacles will also be introduced.

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