The vacuum integrity of freeze dryers is critical for attaining adequate process control and maintaining confidence in sterility assurance which is key for the manufacture of sterile pharmaceutical products. Although discussions on the topic have been published, there is no industry standard established that is based on empirical data or that has a justifiable scientific rationale. This paper published in the Journal of Pharmaceutical Sciences provides a perspective from 14 Pharmaceutical companies on the leak rate specifications commonly used in industry. Using this information the BioPhorum team recommend a best practice for the lyophilizer leak rate test.
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The topic of campaign manufacture for lyophilization processes was discussed by the BioPhorum Lyophilization group. This member only publication is a summary of the approach taken by the major biopharmaceutical companies with experience of campaign manufacture who are members of the group.
Application of first principles primary drying model to lyophilization process design and transfer: case studies from the industry
Lyophilization modeling is well documented in academic circles but has not yet been widely adopted by pharmaceutical manufacturing companies. To facilitate wider adoption and implementation, an accessible Excel–based tool is provided, presenting several fresh examples as a practical introduction to the process of modeling the primary drying phase. Case studies are presented of the tool’s application during process development and scale up which highlight business benefits that have been realized by using the model. Written by members of the BioPhorum’s Lyophilization Workstream, this paper published in the Journal of Pharmaceutical Sciences is intended to serve as a pathway to not only share the collective knowledge on the topic but also accelerate its adoption in the industry.