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.
CGT raw materials
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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.
How are members using leukopaks?
Oct 2021 | Benchmarking, Cell & Gene Therapy, Raw Materials Sourcing
BioPhorum member only survey exploring how member companies are using leukopaks and the key challenges facing the industry.
Transfection reagents​ industry surveys
Oct 2021 | Benchmarking, Cell & Gene Therapy, Raw Materials Sourcing
Two BioPhorum member only blinded surveys to gather data on the use of transfection reagents.
Industry proposal for a simplified registration process of complex and innovative raw materials in Europe
Oct 2021 | Drug Substance, POI - Drug Substance, Publication, Raw materials, Raw Materials Program, Regulatory Governance, Supply Partner
This paper proposes a solution, applicable to all innovative and complex raw materials, to the challenges the biopharmaceutical industry faces with the registration of complex and innovative raw materials in Europe. The biopharmaceutical industry has designed a direct solution to the issue and identified a way to higher quality regulatory submissions, enhanced knowledge, understanding, control and robustness of its products and processes.
Raw Materials: Supplier change notifications: change areas and requirements
Jun 2021 | Deliverable, Drug Substance, POI - Drug Substance, Publication, Raw materials, Raw Materials Program, Supply Partner
This guidance document identifies the relevant change areas, and for each area, exemplifies the type of changes which the biopharmaceutical industry needs to be informed about. It also lists the required information, in terms of supporting data and documentation, to support notification of changes. This guidance is relevant to all raw materials used to produce biopharmaceutical products, including but not limited to cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients. By highlighting the changes biopharmaceutical industry end-users need to know about and specifying the information required, the intention of this industry-aligned guidance is to reduce the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users refrain from building extensive inventories to mitigate against the perceived risks which arise from proposed changes. While complete alignment and standardization on the information which should be provided for changes is not possible, a more robust alignment on the typical information required, as set on in this guidance, will significantly improve the current state.