Pharma & Biotech Test Expo

One of the pharmaceutical industry's leading authorities on drug substances that could harm our DNA kicked off the workshops at the inaugural Pharma & Biotech Test Expo, now being held in Cologne, Germany.

Dr Andrew Teasdale, chair of AstraZeneca's Genotoxic Impurities Advisory Group, conducted the workshop, "Evaluating the risk of genotoxic impurities", at Koelnmesse on Tuesday, February 8, the opening day of the three-day Pharma & Biotech Test Expo 2011.

Drug manufacturers work continually to ensure their products are free of these toxins.

"Most if not all arise through the synthetic process used to manufacture drugs," said Dr Teasdale, whose groundbreaking book on the subject, Genotoxic Impurities: Strategies for Identification and Control, is due to be published later this month by Wiley.

Regulatory authorities' increasing concern with the potential presence of impurities that are genotoxic in drug products led to the publication of the European Medicines Authority guideline, effective from January 1, 2007, Dr Teasdale said.

The US Federal Drug Administration followed suit with a draft guideline, published in December 2008, but there remain many unanswered questions for regulators and industry.

"The biggest problem area we have is to get a common system," said Dr Teasdale, who gave the example of a drug AstraZeneca produced which the regulators of four different countries queried on 10 issues related to genotoxic impurities. Proof that there is no agreement among the regulators was evidenced by the fact that each highlighted a different area of concern, requiring the company to re-test the drug to answer each of the 10 queries. All tests came back negative, but the major headaches the company endured were unavoidable.

Industry and regulatory authorities will have to work together to achieve a common regulatory approach, he said, though progress is being made, particularly in Europe.

Dr Teasdale is actively involved in the work of the International Committee for Harmonisation to develop a common standard for testing of genotoxic impurities, a process that may take several years.

For the latest news on Pharma Test Expo 2011, visit the website: www.pharmatestexpo.com.

Note: Dr Teasdale's presentation at the Pharma Test Expo 2011 is available to download as a pdf file: 
http://www.hulst-expo.com/downloads/evaluating-gi-risk-pharm-test-expo-workshop.pdf (929kb).