Ensuring Safety to Achieve Rapid Release with Aura
Presented in-person at the 3rd annual Cell Therapy Analytical Development Summit in Boston, MA, CSO and co-founder Bernardo Cordovez, Ph.D. discussed new tools required to fully characterize cell and gene therapies for product purity, stability, and viability across all stages of biologic development. Via membrane microscopy, Aura can effectively measure CQAs, USP 788, 1046, and 1047 related to product purity and stability, viability, and particulate controls. Presented are case studies focused on subvisible particle content of AAV formulations at low volumes under different stress conditions and a thorough particle characterization of cellular therapy products including cell aggregation, viability, and product impurities.
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