Risk management for viral clearance: A case study on adoption of platform validation approach and risk management of process changes

Viral clearance (VC) studies are routinely required prior to entering clinical trials or for commercial launch of biopharmaceuticals. With increasing prior knowledge and experience, platform validation can be used to eliminate some VC studies and such strategy has been updated into industry guidelin...

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Bibliographic Details
Published in:Biologicals 2024-08, Vol.87, p.101786, Article 101786
Main Authors: Liu, Na, Wu, Runze
Format: Article
Language:English
Subjects:
Biological Products - therapeutic use
Humans
Platform validation
Process change
Risk assessment
Risk control
Risk management
Risk Management - methods
Viral clearance
Viruses - isolation & purification
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Summary:Viral clearance (VC) studies are routinely required prior to entering clinical trials or for commercial launch of biopharmaceuticals. With increasing prior knowledge and experience, platform validation can be used to eliminate some VC studies and such strategy has been updated into industry guidelines, such as ICH Q5A (R2). In addition, process changes can happen during life-cycle management of a product. In these circumstances, high-risk process parameters need to be identified and corresponding control strategies need to be defined to ensure viral safety of the product. This work describes the design of a science-based risk management tool and how this tool is employed for platform validation and process change scenarios. •A risk management tool for platform validation approach for VC study per ICH Q5A (R2).•A risk management tool for process change control for GMP manufacturing per ICH Q9 (R1).•A practical method resulting in a robust process and a rational monitoring system.
ISSN:1045-1056
1095-8320
1095-8320
DOI:10.1016/j.biologicals.2024.101786