Implementation of Biopreservation Best Practices to address a critical component of cell and gene therapy manufacturingPublished: June 10, 2019
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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:
- Assisting in the selection of the right delivery model, i.e. fresh vs. frozen, and the specific infrastructure and personnel requirements of each, based on which a commercial model is structured
- Reducing the regulatory footprint of Cold Chain, and eliminating the burden of process changes when advancing to clinical trials
- Improving the CQAs, hence potentially improving safety and efficacy of the ATMPs in clinical trials. As such, early incorporation of Biopreservation Best Practices in ATMP manufacturing is highly recommended.
Watch this on demand webinar with Alireza Abazari, MSc, PhD, Scientific Applications Director, BioLife Solutions, Inc as he discusses:
- Mechanisms of cold/freezing injury
- Impact of cold/freezing stress on cell characterization
- Strategies to mitigate cold/freezing injury
Alireza Abazari, MSc, PhD, Scientific Applications Director, BioLife Solutions, Inc
Dr. Abazari has a Ph.D. in Chemical Engineering from University of Alberta, Canada with further postdoctoral training at Massachusetts General Hospital and Harvard Medical School. He joined BioLife Solutions, Inc. in 2015, and is currently active in the International Society for Cell and Gene Therapy (ISCT), Parenteral Drug Association (PDA), American Association of Blood Banks (AABB), and the Society for Cryobiology, to name a few. He has also been a guest lecturer at Rutgers University and University of Washington bioengineering courses, and an invited member of the PDA Task Force for defining Cryopreservation Standards.