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Drug product leachable study survey results | Interview with Sanofi

We spoke to Ken Wong, Deputy Director at Sanofi Pasteur, ahead of his presentation at this November's E&L Europe event to get a sneak peek of his presentation on drug product leachable study survey results, the main challenges faced by the industry, what he is most looking forward to at the event and more.

Your presentation will look at drug product leachable study survey results, can you give us a sneak peek of what delegates will hear?

At the end of 2018, the Extractables and Leachables Safety Information Exchange (ELSIE) completed a leachable study benchmarking survey. The focus of this survey was liquid and lyophilized injectable products. The goal is to have a clear understanding of current drug product leachable practices among ELSIE’s members and to explore possible common practices and divergences of practices.   A simple example can be when 3 lots of drug products are staged for a leachable study, are we using 3 lots of final packaging components or 3 lot of drug products or a combination?

Why did you choose to tackle this topic?

Drug product leachable studies link directly to new submissions and there are sensitivities with new products. The approach or practices of leachable studies are not typically presented in conferences. In the ELSIE consortium, we have the means and mechanisms to conduct such a benchmarking survey among a variety of types of companies in a blinded fashion.  Many have a good idea of general leachable practices, however, we don’t have a clear picture what are the current/common practices and where are the divergence of approaches from ELSIE members. The knowledge could help members to improve their internal E&L programs or assist the consortium in identifying topics that could benefit from collaborative discussion.

What are the main challenges in your day-to-day work relating to E&L?

There are several, such as navigating upcoming changes in regulatory expectations, improving efficiency of our E&L approaches, driving harmonization and simplification of E&L programs across the industry.

Where is the extractable and leachable field headed in coming years and what’s revolutionising extractable and leachable research?

Collaborative efforts such as ELSIE could prove a valuable resource to streamline E&L processes and provide a forum for sharing knowledge, benchmarking and facilitating consensus on harmonized approaches.

What are the major challenges that the extractable and leachable industry is facing?

Specifically for bioprocessing equipment, the requirements and requests vary among agencies to a point where the biopharma industry and suppliers need to collaborate, and also discuss regulatory expectations with agencies to better understand those perspectives and together seek ways to advance scientific and regulatory approaches to everyone’s benefit. This is where I believe an industry consortium can play a critical role in this current environment.

What are you most looking forward to hearing about at E&L Europe 2019?

Gaining insights into new E&L trends and regulatory expectations.

What is one thing you hope to learn or discuss with your peers at E&L Europe 2019?

Discussing common E&L challenges, sharing best practices and exploring ways to enhance collaborative activities such as ELSIE.

Why do you feel it’s important for companies to attend E&L Europe 2019?

It provides a different venue to network with different groups of E&L experts and to share regulatory experiences and discuss specific approaches/strategies of common challenges with others.


  • Ken Wong

    Deputy Director Sanofi Pasteur, USA

    Specialties: * Qualification of process stream contact materials including single-use technologies and packaging materials.

    * Extractables & Leachables compliance remediation strategy development, execution, implementation and realization.

    * Container closure intergrity test, Extractable and Leachable (E&L) test methods development and validation.

    * Strategy development for process contact and packaging material changes and specification changes.

    * Analytical laboratories (CRO) managements and technical assessments.

    * Risk ranking / assessment model design.

    * Shipping cold chain and container qualification.