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.
viral clearance
Viewing related articles
Viral clearance paper implementation tracking survey results 2022
Apr 2023 | Benchmarking, Deliverable, Deliverables Report, Development Group, POI - Development Group, Viral Clearance
For the last three years, the BioPhorum Viral Clearance team have completed a short survey on their published papers to understand how they have been used and the response of regulators if used to support filings. This is the report for 2022
CGT Viral clearance validation aspects
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Supply Chain to Patient, Validation
A BioPhorum member only survey to understand viral purification and clearance practices member companies are undertaking in CGT.
Viral Clearance worst-case conditions presentation at PDA Viral Clearance conference
Jun 2022 | Conference, Deliverable, Deliverables Report, Development Group, Viral Clearance
This member only resource developed by the BioPhorum Development Group Viral Clearance team is based on their analysis of the worst-case conditions benchmarking survey and was presented at the PDA Viral Clearance conference in Brussels in June 2022.Â
Modular Viral Clearance for IND filing benchmarking survey
Oct 2021 | Benchmarking, Deliverables Report, Development Group, Viral Clearance
A benchmarking survey on the experiences in applying prior knowledge and modular claims to health authority regulatory submission for clinical programs and licensure applications.
Viral Clearance worst-case conditions presentation
Oct 2021 | Conference, Development Group, Viral Clearance
Poster presentation at BPI East based on analysis of the Viral Clearance worst-case conditions benchmarking survey.
Viral Clearance worst-case conditions benchmarking survey review and analysis
Oct 2021 | Benchmarking, Development Group, Viral Clearance
A benchmarking survey looking at worse-case conditions, which is contributing to a paper that the team are currently writing.
Justification of small-scale models: an industry perspective
May 2021 | Deliverable, Development Group, POI - Development Group, Publication, Qualification of Small-Scale Models
Small-scale models (SSMs) are widely used in the biopharmaceutical industry. These models are used for process development and optimization, scale-up, technology transfer, process characterization, process validation, virus clearance studies, and resolution of deviations encountered during manufacturing throughout a product’s lifecycle. SSMs are also referred to as ‘scale-down models’ or ‘scaled-down models’. Demonstration that an SSM is representative of the large-scale manufacturing system is called ‘small-scale model qualification’ (SSMQ), which is sometimes also referred to as ‘assessment’, ‘evaluation’, or ‘verification’. The demonstration is an important task that supports process validation and is required by regulatory authorities. However, design, execution and analysis of SSMQ studies can be challenging due to the lack of clear guidance on current best practices. This white paper provides options and tools for design, execution, and data analysis of SSMQs together with illustrative case studies.