Subvisible Particle Identification & Characterisation by Multi-Technique Methods

Presented by

Dr Jonas Hoeg Thygesen & Colin Merrifield

About this talk

Observable foreign and particulate matter has for a long time been recognized as a critical quality attribute for production of injectable protein formulations. Recently, a focus shift towards these particles and even smaller particles (particulate matter or subvisible particles) has been seen from the pharmaceutical industry, academia and the different regulatory bodies. Two of the central documents in this context are: 1. The FDA Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products1 and 2. United States Pharmacopia Chapter 2

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