A BioPhorum member only survey to understand viral purification and clearance practices member companies are undertaking in CGT.
CGT Viral clearance validation aspects
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CGT Validation
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CGT method validation controls bench-marking survey
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Validation
A BioPhorum member only survey is to gather information to benchmark what analytical controls member companies are currently using to establish methods to test identity, strength, potency and purity.
CGT Leveraging process characterization data to accelerate validation bench-marking survey
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Validation
A BioPhorum member only benchmarking survey to understand the current challenges and strategies undertaking regarding leveraging process characterization data/use of platforms to accelerate validation.
Why validation is key to the industrialization of cell and gene therapies
Oct 2022 | Cell & Gene Therapy, Deliverable, Publication, Validation
Commentary provided to ‘Chemistry Today’ following an interview with one of the lead authors of the BioPhorum CG&T Validation challenges publication. This article highlights, from the lead authors perspective, the unique challenges and possible solutions when attempting to validate cell and gene therapy products.
Proposed solutions for cell and gene therapy validation challenges
Oct 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Publication, Validation
This commentary highlights the published work from the BioPhorum Validation workstream indicating the unique challenges and possible solutions when attempting to validate cell and gene therapy products.
Viral clearance studies prior to Phase I/II and inclusion in IND submissions for AAV product survey
Oct 2021 | Benchmarking, Cell & Gene Therapy, Validation
A BioPhorum member only survey to understand how companies are performing viral clearance studies prior to Phase I/II and if members are including these studies within IND submissions for AAV products.