Dr. Andrew Teasdale’s relationship with Lhasa began during his career at AstraZeneca. He is globally recognised as a leading expert in pharmaceutical impurities, including N-Nitrosamines, genotoxic impurities, and elemental impurities. As author of the purge scoring methodology for impurity control, he has worked with Lhasa since the inception of Mirabilis, the solution for controlling potentially mutagenic impurities, which was released ten years ago.
“After developing the purge factor concept it was always my aim to move from a paper-based system reliant on considerable personal expertise to an in silico system where knowledge and data on a scale way beyond the capacity of an individual could be leveraged. Right from the first discussions with Lhasa it was clear this was a shared dream. Mirabilis as it now stands is the true incarnation of that dream.” Dr. Andrew Teasdale
In collaboration with an industry consortium (including Dr. Andrew Teasdale), Lhasa developed a solution that enables confident application of purge rationales to impurities. Engagement with global regulatory bodies has further enhanced Mirabilis, providing the standardisation needed for consistent regulatory acceptance. Successful implementation of ICH M7 Control Option 4, supported by Mirabilis, has been demonstrated to reduce analytical testing time by 77%.
“Our relationship with Andy is a great example of how our valuable community supports the development of Lhasa solutions for overcoming scientific and regulatory challenges” Dr. Crina Heghes, Deputy CEO at Lhasa Limited, and CEO of Consult Lhasa, commented on the news. “Andy has offered immensely valuable support to Lhasa over the last ten years, and I look forward to continuing our close collaboration within both Lhasa and Consult Lhasa.”
Launch of Nitrosamine webinar series
Dr Teasdale will be bringing his expertise to part of an upcoming Lhasa webinar series on nitrosamine risk assessment later this year. This series will guide scientists through the complex risk assessment workflow, from predicting formation and control, to qualification and defining acceptable intake limits in 4 key events:
• Formation: Easily identify, control and de-risk the formation of nitrosamines.
• Qualification: Confidently identifying the mutagenic potential of novel nitrosamines and other Cohort of Concern impurities.
• Acceptable intake (AI): Support to define scientifically defensible AI limits for complex or novel nitrosamines beyond the CPCA.
• Control: Easily control and de-risk the formation of nitrosamines.
To discover how Lhasa solutions support confident nitrosamine risk assessments, don’t miss this insightful nitrosamine series. Register to join the mailing list to stay updated, indicating which events you are interested in.