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ICH Q5A(R2): ‘More Regulatory Flexibilities Than Hurdles’

 
• By Vibha Sharma

CRO executive Horst Ruppach discusses the critical factors that drug manufacturers must consider to ensure compliance with the revised ICH Q5A(R2) guideline on biologics viral safety. Thorough documentation and proactive engagement with regulatory bodies are key to navigating the complexities of viral safety evaluation in biotechnology products, he says.

Medical Development Laboratory: Caucasian Female Scientist Looking Under Microscope, Analyzes Petri Dish Sample. Specialists Working on Medicine, Biotechnology Research in Advanced Pharma Lab
ICH Q5A(R2) guideline allows for reduced viral clearance studies by leveraging Prior Knowledge (Shutterstock)

It has been around a year since the International Council for Harmonisation adopted revised guidance on ensuring the viral safety of biotechnology products derived from cell lines of human or animal origin.

About The Expert

Horst Ruppach is executive director for scientific and portfolio global biologics at Charles River Laboratories, which is the business unit of contract research organization Charles Rivers that addresses the quality and safety of

Following its publication in November 2023, the ICH Q5A(R2) guidance introduced new strategies to prevent viral contamination

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