Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
The ICH guideline for assuring the viral safety of biotechnology products derived from human or animal cell lines. It sets a three-pronged strategy: characterise and test cell lines and raw materials for viral contaminants, evaluate the manufacturing process for its capacity to clear or inactivate virus, and test the product at appropriate stages — so viral safety is designed and demonstrated, not assumed.
Biotechnology products derived from characterised cell lines of human or animal origin — recombinant proteins, monoclonal antibodies, and related products. The R2 revision (2023) modernised scope and analytics for newer modalities and methods, including next-generation sequencing as a testing approach.
- 01Characterise and test master and working cell banks for viral contaminants
- 02Control and screen raw materials of animal or human origin
- 03Validate viral clearance with representative small-scale spiking studies
- 04Demonstrate clearance across complementary, orthogonal process steps
- 05Test at appropriate in-process and product stages and justify the overall strategy
R2 reached ICH Step 4 in November 2023, updating the 1999 guideline to broaden scope for newer product types and to recognise modern analytical methods such as next-generation sequencing.
ICH Q5A(R2): frequently asked questions
Quick answers to common questions about ICH Q5A(R2).
What is ICH Q5A(R2)?
ICH Q5A(R2) — Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin — is a guideline issued by the International Council for Harmonisation. The ICH guideline for assuring the viral safety of biotechnology products derived from human or animal cell lines. It sets a three-pronged strategy: characterise and test cell lines and raw materials for viral contaminants, evaluate the manufacturing process for its capacity to clear or inactivate virus, and test the product at appropriate stages — so viral safety is designed and demonstrated, not assumed.
Who does ICH Q5A(R2) apply to?
Biotechnology products derived from characterised cell lines of human or animal origin — recombinant proteins, monoclonal antibodies, and related products. The R2 revision (2023) modernised scope and analytics for newer modalities and methods, including next-generation sequencing as a testing approach.
What are the key requirements of ICH Q5A(R2)?
ICH Q5A(R2) requires, among other things: Characterise and test master and working cell banks for viral contaminants; Control and screen raw materials of animal or human origin; Validate viral clearance with representative small-scale spiking studies; Demonstrate clearance across complementary, orthogonal process steps.
When was ICH Q5A(R2) last updated?
The current version of ICH Q5A(R2) dates from November 2023. R2 reached ICH Step 4 in November 2023, updating the 1999 guideline to broaden scope for newer product types and to recognise modern analytical methods such as next-generation sequencing.
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