BioPhorum Drug Substance Closed Systems in Controlled Non-Classified Workstream has recently published its room...
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As regulatory complexity and scrutiny continue to grow, collaborative industry bodies are, without doubt, the most effective way for industry to determine how to meet regulatory guidance through ‘strength in numbers’ using a ‘common voice’. This is at the core of BioPhorum’s approach.
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.
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.