ICH Q5C Stability testing of biotechnological/biological products - Scientific guideline
Table of contents
This document covers the generation and submission of stability data for well-characterised proteins and polypeptides, their derivatives and products of which they are components, and which are isolated from tissues, body fluids, cell cultures, or produced using rDNA technology. It may also apply to other types of products, such as conventional vaccines, after consultation with the appropriate regulatory authorities.
Keywords: Stability, cytokines, erythropoietins, plasminogen activators, blood plasma factors, growth hormones and growth factors, insulins, monoclonal antibodies, vaccines