Endotoxin Testing in Transition: Qualifying Recombinant Reagents Without Inviting Observations

Recombinant reagents are moving from option to expectation in bacterial endotoxin testing. For many laboratories, the question is no longer whether to switch, but how to do it in a way that holds up at inspection.

In this session of the Pharmig India webinar series, presented by Pharmig (UK) and Pharma Now, Miriam Guest of Charles River joins for a practical conversation on what a lab needs to show before it changes method.

What you will take away:

• What regulators expect when a lab qualifies recombinant reagents

• How to plan the comparison against your current LAL method, and what to document

• The common gaps that lead to observations, and how to avoid them

• A preview of the endotoxin discussion at Pharmig India 2026

The hour opens with a 10-minute framing talk, followed by a 30-minute moderated conversation and live audience Q&A.