FDA Researchers Seek Ways to Avoid Shelf-Life Chemical Reactions in Complex Proteins

FDA researchers are developing methods to examine and control chemical reactions that can impact the shelf-life, quality, safety and efficacy of protein-based biopharmaceuticals.

The reactions — involving the unwanted binding of individual oxygen atoms to complex proteins — can occur over time during a product’s shelf-life, and can later trigger unwanted immune responses in patients.

Researchers in CDER’s Office of Biotechnology Products refined an antibody-binding assay and found that different proteins undergo the process at different levels and at specific sites, depending on temperature, time and the presence of metals or additives that can accelerate the reactions.