Insights into freeze-thaw processes for therapeutic protein formulations
July 14-17, 2019
For transport logistical reasons and for the decoupling of DS and DP shelf-life, most Biologics Bulk Drug Substances (BDS) are frozen and thawed before further processing. There are contradictory reports and publications on the influence of freezing processes - sometimes ultra-fast freezing is worse in terms of increased aggregate formation, sometimes slow freezing is inferior. Effects may only be visible upon subsequent long time storage (1, 2). The influence of the thawing process is usually neglected in the considerations and investigations, although here also protein can be damaged.
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Karoline Bechtold-Peters, Jakob Buecheler, Roberto Marangoni, Oliver Bluemel, and Wolfgang Friess, "Insights into freeze-thaw processes for therapeutic protein formulations" in "Biological and Pharmaceutical Complex Fluids III: Protein Self-Assembly, Rheology and Interfacial Properties", Samiul Amin, Manhattan College, USA Miguel Rodrigues, University of Lisbon, Portugal Paolo Arosio, ETHZ, Switzerland Eds, ECI Symposium Series, (2019). https://dc.engconfintl.org/bpcf_iii/6