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.