This document outlines a general strategy for drug substance and/or drug product manufacturing processes expected to undergo process performance qualification with considerations unique to gene therapy. It addresses the specific requirements of the gene therapy industry, as general validation templates from the biologics industry may not be entirely applicable.
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This presentation, developed by the BioPhorum Validation team reviews the regulatory challenges faced in cell and gene therapy with a focus to identify and use appropriate analytical controls when dealing with both limited regulatory guidance and limited materials.
This paper evaluates the applicability of the current understanding of viral clearance to the products and processes employed in CGT manufacture to assure the viral safety of these therapies. Unique considerations for preventing contamination through raw material risk mitigation are highlighted. Guidance on viral clearance strategies for inactivation and removal are also provided. This guidance focuses on adeno-associated viral vectors but may also apply to other viral vectors.
A BioPhorum member only survey to understand viral purification and clearance practices member companies are undertaking in CGT.
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.
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.
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.
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.