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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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.Â
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Mar 2022 | Deliverable, Deliverables Report, Drug Substance, POI - Drug Substance, Publication, Raw Materials Program
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BioPhorum approach to the registration of innovative raw materials using quality by design (QbD) principles
Jan 2022 | Deliverable, Drug Substance, POI - Drug Substance, Publication, Raw materials, Regulatory
BioPhorum has defined a best practice approach to the registration of innovative and complex raw materials. The approach is based on quality by design(QBD) principles. It is applicable to different families of non-compendial raw materials in the manufacture of biologics. The approach has already been used by BioPhorum member organizations and accepted by national health authorities.