Chat with us, powered by LiveChat

How to develop impurity control strategies without analytical testing

10 am (EST) / 3 pm (GMT) / 4pm (CET)

This webinar detailed how to develop control strategies in line with ICH M7 guidelines without expensive and time-consuming analytical testing. We showed how you can assess carryover risk for potentially mutagenic impurities (including nitrosamines) in your drug development workflow.

We were delighted to have Senior Principal Scientist Andy Teasdale presenting. Andy is the chair of AstraZeneca’s Impurity advisory Board, and has developed a wealth of knowledge over the last 30 years working in the pharmaceutical industry. He is leading AstraZeneca expert for a number of key impurity areas, including mutagenic impurities. Andy described the concept of purge factors and purge scoring for controlling potentially mutagenic impurities outside of the lab. His talk was titled ‘Industry perspective: Controlling potentially mutagenic impurities – Using calculations to support purge arguments under ICH M7’

Lhasa Limited Scientist, Emma Pye works as part of the Science team at Lhasa spoke on our in silico tool for controlling potentially mutagenic impurities – ‘Mirabilis’ – for the last year. She presented ‘Purge Factors as part of M7 Assessment of mutagenic impurity risk – Using Mirabilis to assist in control strategies.’

The talks were be followed by a live Q&A