Standard Protocol for Deriving and Assessment of Stability, Part 2: Aseptic Preparations (Biopharmaceuticals), Edition 4, August 2020 (Yellow Cover)

Biopharmaceuticals incorporate a wide range of products such as vaccines, immunoglobulins, monoclonal antibodies and cell and gene therapy products. This document intends to cover biopharmaceutical products which are aseptically manipulated, principally monoclonal antibodies although many of the principles will also apply to other proteins and polypeptides. This document does not include reference to cell based therapies (Advanced Therapy Medicinal Products), vaccines or blood components.