This BioPhorum approach aims to define the polymer-based transfection reagent release testing needed for cell and gene therapy processes.
Quality by design (QBD)
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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.
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.