ISO 13485: The Perfect Fit for Peptide-Based In Vitro Diagnostics

Webinar replay

Peptides or peptide mixtures are used in in vitro diagnostics (IVD) to measure the presence or concentration of a biomarker molecule that indicates disease. They have to meet laboratory expectations to ensure the sensitivity and specificity of the test. It is crucial to have a reliable and trusted source of quality peptides. To meet the requirements for IVD industries, robust manufacturing processes, traceability, and reporting of crucial change control for commercial supply have to be implemented.

Bachem’s Center of Excellence for Custom Synthesis in St. Helens, UK, is ISO 13485 certified to manufacture peptides as critical raw materials for medical devices.  Join our webinar “ISO 13485: The Perfect Fit for Peptide-Based In Vitro Diagnostics” to learn more about how we ensure that our peptides for IVD applications meet regulatory requirements.

Speakers

Julie Marley
In 1987, Julie received a B.Sc. in Chemistry from the University of Liverpool, UK. She worked as a peptide chemist at Peninsula Laboratories Europe Ltd (PLE) until 1988. After working for one year in the Peptide R&D group at Astra Zeneca in Alderley Park, UK, she returned to PLE and completed her M.Sc / Ph.D. part-time at the University of Manchester, UK. She has held various positions within PLE and subsequently Bachem (UK) Ltd. She became Site Manager in 2013.

Joanne Capener
Joanne Capener studied engineering and worked for 15 years as Quality Engineer and Quality Specialist for leading Life Sciences Companies in the manufacture of IVD Devices and Class II Medical Devices. She is a IRCA trained Lead Auditor for ISO13485:2016 and joined Bachem (UK) Ltd. in 2020 as QMS Manager.

Moderator

Stefanie Dobitz
Stefanie Dobitz studied chemistry at the Justus Liebig University Giessen (Germany), receiving her M.Sc. for her work on stereoselective oxidations using peptide-based organocatalysts. She earned her doctoral thesis from ETH Zurich (Switzerland) studying the synthesis and biological evaluation of oligoproline-based peptide ligands for tumor targeting.
Stefanie joined Bachem AG (Bubendorf, Switzerland) in 2017. After increasing responsibilities in the Sales Department at Bachem, she became Group Leader Customer Synthesis Sales in 2019. In her role, Stefanie supports Bachem`s Asian and European customers with high quality peptides for cosmetics, in vitro diagnostics, and R&D.