The BioPhorum response to the Annex XV Report on the proposal for universal PFAS restrictions. It is considered by the BioPhorum collaboration that unless ECHA provide the biopharmaceutical manufacturing industry with appropriate exemptions or derogations to find, test and validate alternatives and execute a transition out of these materials (where alternatives are available), there will be a real threat to the global availability of critical vaccines and biotherapeutics.
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BioPhorum feedback on ICH Q5A (R2)
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BioPhorum’s in-depth feedback includes 70 line-by-line, detailed comments, including the rationale for the points and any proposed changes/recommendations that are deemed necessary by the team to ensure a harmonized implementation across industry and regulatory agencies.
BioPhorum approach to the registration of innovative raw materials using quality by design principles – Appendix 2: Protein A resins
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The BioPhorum approach to the registration of innovative raw materials using quality by design principles, explored the diversity of registration practices for innovative and complex materials and illustrated this through a survey of the current state. This appendix consists of an introduction to Protein A, the process followed for identifying critical material attributes, and controls and principles for registration that would offer future flexibility of supply.
BioPhorum feedback on Columbia decree
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Colombia decree consolidated feedback from the BioPhorum Post Approval Change Management workstream, Colombia sub-team. This content is only available to BioPhorum members.
BioPhorum environmental sustainability roadmap 2022
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Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health. The healthcare sector is responsible for 4–5% of global emissions, more than 70% of which are driven by supply chains.
The user requirement specification (URS) of the future
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The purpose of this paper is to stimulate debate in the biopharmaceutical industry and to work toward industry-wide alignment on the creation and use of optimized and lean user requirement specifications (URSs) for equipment, facilities, utilities and systems qualification.
Media fingerprinting of cell culture media a standardized analytical test method suite and three-tier approach
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This paper gives a best practice recommendation for fingerprinting cell culture media. It includes a standardized analytical test method suite, a three-tier testing approach and flowcharts that guide the reader to choose a suitable media fingerprinting method based on their goals and the raw material properties.
Risk-based strategies to support revalidation and the assessment of requirements to maintain the validated state of equipment, process and facilities used for commercial and clinical manufacturing
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This paper describes risk-based alternative strategies for defending the suitability of equipment and facilities requiring revalidation. These robust and risk-assessed approaches include real-time review, routine monitoring and in-/at-line alarms and measurements to help identify what data and testing are critical to assure the continued validated state of the equipment.
Raw materials strategy
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This document communicates a strategic framework for solving technical problems relating to managing raw materials in the biopharmaceutical industry and encourages biopharmaceutical end-users and suppliers to work together to address specific raw material and end-user process needs. It highlights the importance of implementing industry solutions and sign-posts a range BioPhorum raw materials publications. These establish standard definitions, a common understanding of raw material requirements, and the importance of regulatory, quality, and supply chain links.
Operational vision: Adoption of in-line monitoring and real-time release
Jun 2022 | Cell & Gene Therapy, COVID 19, Deliverable, Deliverables Report, Development Group, Drug Substance, Fill Finish, Information Technology, Inline Monitoring and Realtime Release, POI - Drug Substance, Publication, Supply Partner, Technology Strategy
Historically, the biopharmaceutical industry has relied on traditional pharmaceutical manufacturing practices to make and release products. This publication examines the future of biopharmaceutical manufacturing by presenting the vision of fully implemented in-line monitoring (ILM) and real-time release. This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.