Future Trends To Control Risks From Extractables and Leachables

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 than 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. The 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 of that. However, in 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 set up 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 1990s.
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.

Followed by Challenges and Best Practices for Extractables and Leachables in ophthalmic drug products

Until 2018 ophthalmic drug products (ODPs) were assessed in the way parenteral drug products are being assessed from an Extractables and Leachables perspective. Nevertheless, ODPs differ significantly from PDPs in terms of route of administration, toxicological end-points, and the nature of the container closure system. Hence, it is needless to say that E&L testing in ODPs requires a specific study design compared to other dosage forms. For example, low-density polyethylene containers allow for volatile and semi-volatile compounds to migrate through the material into the ophthalmic solution and, as such, compromise the product’s safety. This implies that secondary packaging components and even tertiary packaging components should be included in the E&L risk evaluation. Furthermore, until now no consensus has been reached on the toxicological limits to be applied during the safety assessment of leachables in ODPs. Given that the scientific knowledge on E&L testing is continuously evolving, as are the expectations of the agencies, the industry is faced with an increasing uncertainty on what would be an adequate approach for qualifying their packaging systems. In this webinar, best practices and challenges related to the design of an E&L study for ODPs will be addressed.
Presented by Kathleen Lava PhD – E&L Expert Nelson Labs Europe

Kathleen Lava successfully completed her Ph.D. in Chemistry at the University of Leuven (Belgium) in 2012. Afterward she performed postdoctoral research in the team of Prof. Richard Hoogenboom at Ghent University. In 2016, she started at Nelson Labs Europe as a Study Director for Extractables and Leachables. She is part of the team specialized in Large Volume Parenterals, Ophthalmics, and Disposables, with a focus on ophthalmic drug products.
Sponsored by Nelson Labs

Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.