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

Introduction

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.

Due to the intricate nature of biopharmaceuticals the assessment of stability is highly complex and requires specialist input in order to interpret data from a multiple of orthogonal techniques, and to design robust stability trials.

Attachments

Change history

  1. Stability Part 2 Biopharmaceuticals V5 updated
  1. Updated following comments from MHRA on version 4. Review and update of references. Improved wording and clarity
  1. Published