Virtual European Workshops on Extractables & Leachables for Pharma & Biopharma

The identification of extractables, leachables and chemical migration is a challenge for manufacturers and suppliers of packaging materials, medical devices and food contact materials. E&L analytics is already complex, but it is compounded by legislative and regulatory efforts to recycle plastics. Analytical methods need to screen for not only the known components but also identify degradants and other unexpected compounds. Manufacturers, producers and retailers face the challenge of keeping up with evolving requirements and developing and adapting strategies to reduce plastic waste.

Thus, ways are being explored to incorporate more recycled plastics into products and packaging while maintaining excellent safety, quality and performance characteristics. As they innovate and combine new materials, companies must demonstrate safety and confirm compliance before bringing their products to market. This again increases the demand and importance of highly effective analytics.

Participation is free of charge. Presentations delivered in English.

Register now for this virtual event and share knowledge and challenges with peers and E&L experts.

Who Should Attend?

The webinars are focused on the needs of scientists working in the area of Extractables & Leachables and Food Contact Materials. During these webinars, attendees will learn:

• Upcoming and new regulations in the field of food, pharma, biopharma and medical devices
• Targeted and non-targeted screening workflows by using Waters_Connect
• Characterization and structural elucidation of unknowns
• Choice of chromatographic techniques, extraction methods and analytical standards & reagents

EPISODE 1 - Virtual European Workshop on Extractables & Leachables for Pharma & Biopharma

Presentation: A risk-based assessment approach to extractable/leachable studies of plastic components and systems used in (bio)pharmaceutical manufacturing

Presentation: The Pattern Targeting Application

Register now & join the discussion!

Presenter: Lijun Song (Bioprocess Validations Specialist, 3M)

Lijun Song is a Senior Validation Engineer at the 3M filtration validation laboratory located in Belgium. After her PhD in Medicinal Chemistry at Ghent University, she joined the 3M validation team in 2019. She focuses on filter compatibility validation and extractable/leachable studies.

Presenter: Mike Ludlow (Science Lead working in the CMCAnalytical and Materials Science Team, Drug Development Solutions (part of Alliance Pharma Inc))

Mike Ludlow is the Science Lead working in the CMCAnalytical and Materials Science Team within Drug Development solutions based in Cambridgeshire, UK (Formerly known as LGC). The team supports an extensive external client base providing a variety of chromatographic and spectroscopic techniques covering both organic and inorganic characterisation. He has over 20 year’s experience in pharmaceutical analysis primarily in the areas of extractables and leachables testing and the identification of impurities such as Nitrosamines in a GxP environment. Before working for DDS, he worked in the Corporate Analytical Function of ICI’s Chemicals and Polymers Division providing support to R&D scientists developing speciality polymer products.

Presenter: Jeff Goshawk (Applied Informatics, Research & Development, Waters Corporation)

Jeff holds a BSc degree in Mathematics from the University of Portsmouth and a PhD in Applied Mathematics from the University of Liverpool. He joined Micromass as a software developer in July 2000 and worked on the development of MassLynx and the application managers ChromaLynx, MarkerLynx and MetaboLynx. In 2013 Jeff changed role joining the Waters Scientific Operations organisation as a member of the toxicology group and was exposed to the disciplines of sample preparation and sample acquisition in addition to developing data processing workflows using UNIFI. In 2017 Jeff transitioned into the Applied Informatics group in Scientific Operations to help to solve problems not addressed by mainstream software solutions. It was in this role that development on the Pattern Targeting Application began.