Stability of the protein structure is an important feature in preserving the safety and efficacy of biopharmaceuticals.

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.

Edition 5
Issued June 2021 –
1. Updated following comments from MHRA on version 4
2. Review and update of references
3. Improved wording and clarity