Future Trends To Control Risks From Extractables and Leachables

09th February 2021 | 10:00am EST | Jason Creasey, Managing Director at Maven E&L Ltd |BOOK FREE SEAT FOR THIS WEBINAR

An ICH Q3E working group has now been formed, all be it without the planned face to face meeting due to a global pandemic. When underway I would like to hope that their focus will be risk based as I believe Extractable & Leachables work is at its heart an exercise in risk management.

Therefore, in talking about future trends in risk control I would begin with an input of technical risk assessment. Risk control then follows risk assessment, the activities undertaken in the form of extractable and leachable studies should be directed only to the risks which the risk assessment defines as high and probable rather any low and unlikely.

When studies are undertaken the analytical methods must be capable of risk reduction by high-quality identification and high-quality quantitation. Output of these studies is another risk assessment – a safety assessment. These requirements in-essence will form the basis of the future trends to resolve.

  • Analytical methods continue to develop and it’s clear that Mass Spectroscopy will remain a very important part in that. However, the future we must resolve its current limitations and future trends move in that direction. This presentation aims to show that.
  • There is the linked issue of Analytical Evaluation Thresholds (AETs). Future trends must resolve the current ambiguities in their application and practice. In this presentation I will discuss work underway
  • Finally, there is the safety risk assessment. It will remain a key process step, but we must resolve the inconsistency in how it is conducted and agree with all stakeholders a common method, universal agreed.

I hope to show in this presentation that the future for E&L is bright but needs a push or two in the right direction.

“Golden Boy with feet of clay

Let me help you on your way

A proper push will take you far –

But what a clumsy lad you are!”

(Quote from Writer Stephen Donaldson)

Presented by Jason Creasey, Managing Director at Maven E&L Ltd

Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independent consultant providing advice in the area of extractables and leachables, after working for GSK in the area of extractables and leachables since the mid 1990’s.

Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority relating to the support that GSK has given to extractables and leachables (E&L). Before setting up Maven E&L Ltd, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. This included; biopharmaceutical and small molecules including Inhalation, Parenteral and Cell & Gene Therapy use. He has had the pleasure of commenting on PQRI guidelines on E&L for GSK, the E&L section in EMEA guidelines on inhalation and nasal products and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

Jason has been a member of several external groups concerned with the development of best practice guides for extractable and leachables issues these include; the IPAC-RS material working group, BPOG and continues as a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE. Currently he is working and commenting on risk- based approaches to E&L requirements, which he hopes will form part of an ICH guidance in the not too distant future.


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