Live Q&A – E&L Assessment of Cell and Gene Therapy. On Demand.

extractables and leachables assessment of Cell and Gene Therapies

In case you missed it here is a recording of our live Q&A session focused on extractables and leachables assessment of cell and gene therapies (C&GTs).

To get the conversation started, we also recently released a series of 3 blogs. First we described how and why E&L in cell and gene therapies are important, followed by another comparing C&GT with mAb and a 3rd blog looking at simulation studies. So make sure to catch up on those.

Downloads

You can also download a presentation on Extractable & Leachable Assessment of Cell & Gene Therapy Products by Nick Morley.

Cell-and-Gene-Therapy-Products-thb

Speakers

Jason Creasey, Managing Director, Maven E&L Ltd

Jason Creasey is a graduate Analytical Chemist. He set up in 2019 as Maven E&L Ltd providing advice on the topic of extractables and leachables, after working for GSK in this area since the mid-1990s. Before setting up Maven E&L Ltd he was the director of a team of analytical chemists who were responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities.  He has had the pleasure of commenting on OINDP PQRI guidelines on E&L for GSK and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

Sara Ullsten, R&D Section Manager, Cytiva

Sara Ullsten is R&D Section Manager at Cytiva. She manages the extractables and leachables lab, focused on testing polymeric materials and components used in the manufacturing of biopharmaceutical drug substances and products. She has 15 years of experience in the Life Sciences’ field and has held several positions in R&D as a senior scientist, project manager, and section manager. Sara has a Doctors’ degree in chemistry from Uppsala University.

Adeyma Arroyo, Network Technology Leader Single Use Science and Engineering at Roche/Genentech.

Adeyma’s focus is on strategies that support the implementation of single-use systems in clinical and commercial manufacturing in the areas of material science and qualification, extractable and leachables standards and new manufacturing modalities.

Nick Morley, Principal Scientist, Hall Analytical

Nick has over 12 years of experience in the field of extractables and leachables, both in large pharma and at a CRO. He is responsible for providing technical/consultative support to new and existing customers in the field of E&L. Experience working on a range of products including pharmaceutical/biopharmaceutical (inhalation, topical and parenteral), medical device and nicotine delivery systems.

Nick has a BSc in Chemistry, is a BSI Committee member and British representative on the CEN (European standards Committee) working group for extractables and leachables of Electronic Cigarettes & E-liquids.

Moderator

Andrew Feilden, European E&L Strategic Director, Hall Analytical

Dr Andrew Feilden is the European E&L Strategic Director at
Hall Analytical. He joined Hall in November 2019 where he is a technical expert in the field of E&L testing undertaking commercial, operational and technical thought leadership activities. He has presented on the field of extractables and leachables in over 16 countries world wide. Andrew has written a number of papers and publications and is the inventor of 2 patents. He has a degree and D Phil from the University of York, is a Fellow of the Royal Society of Chemistry and was a Scientific advisor to IPAC-RS and ex-cochair of ELSIE.