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.
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The user requirement specification (URS) of the future
Dec 2022 | Deliverable, Deliverables Report, Drug Substance, Lean Qualification and Validation, POI - Drug Substance, Publication
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
Nov 2022 | Deliverable, Deliverables Report, Drug Substance, POI - Drug Substance, Publication, Raw materials, Raw Materials Program, Raw Materials Sourcing
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
Sep 2022 | Deliverable, Deliverables Report, Drug Substance, Multi-Product Facility, POI - Drug Substance, Publication
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
Jul 2022 | COVID 19, Deliverable, Deliverables Report, Drug Substance, POI - Drug Substance, Publication, Raw materials, Raw Materials Program
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.
What is changing in China CMC regulatory?
Jun 2022 | POI - Drug Substance
BioPhorum’s Post-Approval Strategy Team has produced a poster titled What is changing in China CMC Regulatory? It refers to a wide range of changes in areas such as pharmacopeia, e.g., more convergent monographs in CHP 2020 than any other version of the Chinese Pharmacopeia. It also talks about changes in submissions, including excipients and primary packaging materials need to be registered on the Chinese Drug Master File platform before use in products. It can be used by BioPhorum member organizations, displayed in a CMC regulatory office, used at CMC meetings, and shared with colleagues outside the regulatory function.
Media and hydrolysates
May 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Drug Substance, POI - Drug Substance, Publication, Raw materials, Raw Materials Program, Raw Materials Sourcing
This paper discusses the issues around trace elements and gives a suggested approach for developing a method for analyzing trace elements in cell culture media and hydrolysates. The approach is based on a ground breaking BioPhorum collaboration that shared blinded data and compared analytical methods between biopharmaceutical and media manufacturers.
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Mar 2022 | Deliverable, Deliverables Report, Drug Substance, POI - Drug Substance, Publication, Raw Materials Program
A proactive risk-based approach to understanding key factors that can introduce product variability is necessary to avoid delays. One such factor identified is elemental impurity variability introduced by cell culture media. Though the impact of the variability will differ, it is important
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Applying the power of human performance to documentation for successful outcomes
Feb 2022 | Deliverable, Deliverables Report, Drug Substance, Human Performance, POI - Drug Substance, Publication
This paper outlines the application of human performance principles to document design and provides guidance for how to implement this in a biopharmaceutical manufacturing environment, with proven results. A more effective system for creating and revising documents—specifically, one that is
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