The 3rd Annual Extractables and Leachables (E&L) Conference

The 3^rd Annual Extractables and Leachables (E&L) Conference

The 3^rd Annual Extractables and Leachables (E&L) Conference took place in Berlin on the 1^st and 2^nd of December with the aim to educate attendees about the scientific area of E&L and allow members of the E&L community to present case studies and share innovations in the subject.

The Broughton E&L team was in attendance and Paul Hardman, our Managing Consultant CMC, presented on the suitability of current regulations and the lack of regulations in certain new and emerging product areas. He also stimulated a thought-provoking discussion about the need for better regulations relating to the longer-term leaching of polymers and their effect on the environment.

The event was well attended by many of our peers in the E&L industry, so it was great to listen to the other presenters and learn about their research areas. Overall, the conference had a nice mix of something for those new to the topic, some great case studies outlining certain hurdles and how these were overcome, plus presentations on innovations around reference standards and thermal desorption testing.

Below are some of the conference highlights chosen by our Broughton attendees.

Education

Tino Otte from Intertek chaired the conference and presented on how to design and perform E&L studies helping to educate new members of the Extractable and Leachables community about the merits of the thermal desorption technique as an additional tool in the characterization of materials.

Building on the area of educating attendees were three more informative presentations; Andreas Nixdorf of SGS, who focused on the regulatory expectations of ISO 10993-18, Mike Ludlow of Drug Development Solutions who outlined the study design considerations for E&L studies, and Carsten Worsoe of Novo Nordisk who presented on how to assess the E&L of prefilled syringes and the design consideration involved.

Case studies

An interesting case study was shared by Ted Heise of the Med Institute around the extraction conditions for ISO 10993-12 which focused on a round-robin study highlighting the inconsistent nature of extraction studies when performed by different laboratories and putting forward considerations on how to overcome this problem.

Nick Morley of Element presented another interesting case study on a Cell and Gene therapy product covering the many issues involved when performing studies on the single-use systems used in manufacturing these products.

Innovations

Steve Zdravkovic of Baxter showcased a study on the levels of E&L in the rubber stoppers used in liquid and lyophilized vial products. The study observed that lyophilized products showed higher levels of leachables than liquid products in vials which challenged the common perception that less leachables would be observed with these dry formulations.

To complement Steve’s presentation, Ana Kushel of West presented the available extractables information on the West stable of rubber stoppers that can be used for lyophilized drug products and also commented on leachables levels in these drug formulations.

Markus Obkircher shared the E&L reference standards offered by Merck and the proficiency testing efforts that go into producing these standards and ensuring the system suitability of the instruments used to perform them.