Implementation of Biopreservation Best Practices to address a critical component of cell and gene therapy manufacturing

 

June 18th 2019, 08:00 PST; 11:00 EST; 16:00 BST; 17:00 CET

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 will 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
 
  • Mechanisms of cold/freezing injury
  • Impact of cold/freezing stress on cell characterisation
  • Effective strategies to mitigate cold/freezing injury
Presenter
Alireza Abazari, MSc, PhD
Scientific Applications Director
BioLife Solutions, Inc.
View Biography

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