In the manufacturing process of biopharmaceuticals, freezing and thawing are key steps that could potentially impact the quality of the product. Development of a small-scale model is needed to study the effect of freeze thaw stresses on product quality. This poster details the development of a freeze thaw methodology using the Blast Freezer 4002 by Farrar to evaluate the effect of freeze thaw rates on product quality for a monoclonal antibody.  Product quality before and after controlled, fast and slow freeze thaw rates were measured. Best practices for freeze thaw at manufacturing scale were recommended based on the data generated. In addition, the data was compared to a similar study performed in Celsius pak bags using Celsius S3 controlled Freeze Thaw System. This work highlights the learnings from using both systems as well as a comparison of data from small scale freeze thaw evaluation using Nalgene bottles and Celsius pak bags. It also explains how the data generated was used in the development of a risk assessment to build a robust product control strategy.<br/>

Development of a small-scale freeze thaw methodology using Blast Freezer 4002

2019 Spring National Meeting

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