What's Hot in 2024: Next Generation Sequencing

Revision of ICH Q5A guidance for cell bank characterization means replacing in vivo tests with a faster, more robust animal-free NGS assay

The hotly anticipated ICHQ5A(R2) has now been adopted. This key global guideline for the biosafety testing of monoclonal antibodies, recombinant proteins and viral vectors now clearly references the replacement of animal-based viral detection assays with next generation sequencing assays. Accordingly, from an ethical perspective, the use of in vivo assays is increasingly difficult to justify. Moreover, from a GMP perspective, in vivo assays are very difficult to validate for accuracy, specificity, robustness, and limit of detection. This is even more complex for assays like MAP or HAP that have in vivo combined with a serology endpoint, e.g. ELISA.

Given the power of NGS to detect, identify and (most importantly in some cases) discriminate live replicating virus from low risk fragmented viral nucleic acids, this method is being adopted by our industry. Another large benefit of NGS is that it takes as little as 3 weeks versus 8 weeks for MAP, HAP and RAP. To summarize, in vivo assays were the best methods available for the detection of viral threats half a century ago. The updated Q5A guidance means that 2024 will be the time to switch to the best method available today: a GMP validated NGS assay from our partners at PathoQuest. 

More details about how NGS can help you replace animal models can be found here.

-- Michael Mellor-Clark, Chief Commercial Officer, PathoQuest