Lhasa Limited Announces an Industry Collaboration to Address the Challenges of Impurity Purging During Synthesis

LEEDS, England, May 20, 2014 /PRNewswire/ --

Lhasa Limited, a leading global supplier of knowledge-based software and associated databases, today announces an industry collaboration to develop software that can help experts assess the likelihood of the potential carryover of impurities (including those that are genotoxic) without exhaustive analytical testing.

The use of highly reactive compounds is often necessary for chemical synthesis and these can potentially be either genotoxic themselves or generate genotoxic impurities.  However their inherent reactive nature often means that these agents are unlikely to be present in the final product at the end of the synthetic route.  Currently, organisations are required to expend significant effort in order to prove that these impurities are not present in the final product, despite having a robust chemistry-based argument.  This collaboration will address this requirement by generating a semi-quantitative, scientifically robust, transparent and standardised approach for predicting the likely purge of impurities at each stage within a synthesis pathway.

The proposed ICH M7 guideline states that having sufficient confidence that an impurity will be below the acceptable limit means that no analytical testing will be required.  The generation of this scientifically robust and industry standard approach will enable organisations to provide the supporting evidence to justify that an impurity falls below the acceptable limit for the purposes of ICH M7.

On the 17^th of March 2014 the first face to face meeting took place at Burlington House, home of the Royal Society of Chemistry, in London between Lhasa Limited and the initial partners (which include AbbVie, AstraZeneca, Hoffman-La Roche, Novartis and Pfizer).  Building on the approach taken by Dr. Andrew Teasdale at AstraZeneca, Lhasa limited and its partners will steer the development of the software whilst providing their expertise and data.  The project is expected to last for three years and will result in the delivery of fully functional software.

Andrew Teasdale said "It has long been a frustration with many in the industry that we have had to develop often complex and highly sensitive methods to analyse for impurities we know won't be there.  It was against this backdrop that an alternative approach, one based on risk assessment, taking into account the specific physicochemical properties of the genotoxic impurity (reactivity, solubility, ionizability, volatility etc.) and the specific reaction conditions was developed.  To see the original concept now being developed and applied widely across the industry is great and I look forward to seeing this developed still further into the standard tool the partners foresee.  Crucially such a tool will help to ensure effort is focused on those impurities that present an actual risk."  

David Watson, CEO of Lhasa added "whilst individual companies have produced their own approaches to the prediction of purge factors, an industry-wide standardised approach will give weight to the use of such a methodology under ICH M7 and beyond, saving time and money helping to capture existing knowledge in order to solve problems before they arise."

About Lhasa Limited 

Lhasa Limited is a not-for-profit organisation that facilitates collaborative data sharing projects in the pharmaceutical, cosmetics and chemistry-related industries.  A pioneer in the production of knowledge-based systems for forward thinking scientists, Lhasa limited continues to draw on over thirty years of experience to create user-friendly, state of the art in silico prediction and database systems.

We believe in 'Shared Knowledge, Shared Progress'.  Our not-for-profit, member driven status is designed to facilitate collaborative working and confidential data sharing between organisations.  We run collaborative projects with industry, academia and regulatory bodies to continually enhance all our products.

Lhasa's products include the Derek Nexus expert system for predicting toxicity, Sarah Nexus, a transparent statistical system for predicting mutagenicity, Vitic Nexus for managing chemical data and information, Meteor Nexus for predicting metabolic fate and Zeneth for predicting forced degradation pathways.

For further information on this collaboration please contact info@lhasalimited.org or call +44-113-394-6020.