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BioPhorum is increasing its focus on delivering against strategic goals of member companies as outlined in the BioPhorum Biomanufacturing Technology Roadmap. The first step in achieving this is to form a team with a cross-Phorum focus to implement these technologies – the ILM/RTR Adoption team. The team will look at the ongoing work and opportunities to collaborate on environmental, organizational and technical factors that can be most readily addressed at industry level.
Continued process verification (CPV) provides ongoing verification of the performance of a manufacturing process and as such entails the processing of large amounts of data. This paper draws on the experiences of multiple biopharmaceutical manufacturing companies in validating the informatics components of their CPV programs. It sheds light on common issues and provides recommendations and best practices. Computer systems validation is relevant across the lifecycle of a CPV informatics solution. As such the papers scope includes the initial and ongoing activities and deliverables to determine that the solution meets its intended uses and other requirements, for example, data integrity and performance requirements.
Microbial control: Microbiological control for affinity capture chromatography processing: an industry perspective
May 2018 | Drug Substance
Due to the potential for microbial colonization, affinity capture chromatography requires robust microbiological control. In this paper the BioPhorum Microbial Control team addresses the microbial risks and controls associated with affinity capture chromatography. Further the paper sets out an approach to improve understanding of the risks for bioburden, and manage these risks through effective controls during the chromatography process so that bioburden issues will be reduced.