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There is more to Biopreservation than storage on ice or freezing at a rate of -1°C/min. To comprehend the rationale behind Biopreservation Best Practices, a basic understanding of cellular response to cold and freezing is essential. This presentation will identify the critical process parameters (CPPs) of Cold Chain, such as freezing and thawing rates, storage and post-thaw stability, and container type, among others, and will discuss the impact of these CPPs on critical quality attributes (CQAs) such as viability, yield, proliferation rate, and return to function.
We also discuss how the CPPs may impact variability in assay results. In general, implementation of best practices in formulation can directly address multiple process bottlenecks including: GMP compliance, minimizing freezing damage, support stability during storage and against transient warming events, support post-thaw stability, and excipient qualification.
The CQAs may also be improved by adjusting key parameters in the freezing profile. Incorporation of Biopreservation Best Practices conveys important advantages upstream and downstream of ATMP manufacturing, including:
Watch this on demand webinar with Alireza Abazari, MSc, PhD, Scientific Applications Director, BioLife Solutions, Inc as he discusses: