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.
Raw Materials Sourcing
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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
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Nov 2020 | Cell & Gene Therapy, Deliverable, POI - Cell and Gene Therapy, Publication, Raw materials, Raw Materials Sourcing
BioPhorum Cell and Gene Therapy is asking for your help – and is giving you the opportunity to have a say in a scientific community discussion that will influence its suggested testing practices for plasmid release specifications. The team is proposing a platform framework for testing plasmid master cell banks and plasmid DNA.Â
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Oct 2020 | Cell & Gene Therapy, POI - Cell and Gene Therapy, Publication, Raw materials, Raw Materials Sourcing
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