This BioPhorum approach aims to define the polymer-based transfection reagent release testing needed for cell and gene therapy processes.
A proposal to align release standards for transfection reagents
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raw materials
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BioPhorum approach to the registration of innovative raw materials using quality by design principles – Appendix 2: Protein A resins
Mar 2023 | Deliverable, Deliverables Report, Drug Substance, POI - Drug Substance, Publication, Raw materials, Raw Materials Sourcing, Supply Partner
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.
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.Â
Regulatory landscape for cryopreserved apheresis products
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Raw Materials Sourcing
A survey to understand what the industry current understanding of the FDA approach to fresh versus cryopreserved apheresis as a starting material for autologous/allogenic cell therapy programs.
Survey to understand current practice for stability/shelf-life studies for plasmids
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Raw materials
The purpose of this BioPhorum member only survey is to understand current industry best practices, understand member experience and if any of the workstream members has had regulatory success leverage prior knowledge.
Cell and gene therapy critical starting material –establishing release specifications for plasmids
Oct 2022 | Cell & Gene Therapy, Conference, Deliverable, Deliverables Report, Raw Materials Sourcing
A BioPhorum member only deliverable describing the work of the Plasmids subteam
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.
Discussion on plasmids to establish release specifications using a risk-based approach to manage supply
Jun 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, POI - Cell and Gene Therapy, Publication, Raw Materials Program
This paper shares industry feedback after the publication of two BioPhorum papers that complement ongoing efforts in the wider CGT field. It supplements these publications by delving into identity testing and cross-contamination for plasmid master cell banks and plasmid DNA, and other plasmid DNA release tests (including DNA homogeneity, residual DNA and host RNA, and sterility or bioburden).
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.
Trace element variation for chemically defined cell culture media: biopharmaceutical industry requirements and cross-company collaboration to mitigate risks
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
that both manufacturers and supply partners understand the sources of elemental impurities and perform risk assessments to identify mitigation strategies. Such assessments will allow an understanding of the level of risk, and what steps may be taken to dissipate it. This paper is an effort to drive regulatory bodies, drug manufacturers, supply partners and N-1 suppliers toward a common understanding of the problem and possible solutions that can be taken towards risk mitigation. Though there may not be a single or ideal solution for this issue, a common rational approach can be taken by all parties to understand the impact on their processes and products, to drive identification of mitigation strategies.
