SUMMARY
The discussion centers on the pH change observed in a 10mM histidine (His) buffer during the lyophilization of a 50mg/ml monoclonal antibody (mAb) solution. Initially, the buffer had a pH of 6.2, but upon reconstitution, the pH increased to 6.5. Participants noted that histidine buffers are generally less susceptible to pH changes during lyophilization compared to phosphate buffers. However, the specific composition of the His buffer, including the starting materials and pH adjustment methods, is crucial for understanding the observed pH shift.
PREREQUISITES
- Understanding of histidine buffer preparation and its components.
- Knowledge of lyophilization processes and their effects on protein stability.
- Familiarity with pH measurement techniques and implications for protein formulations.
- Basic concepts of monoclonal antibody (mAb) stability and formulation.
NEXT STEPS
- Research the effects of different buffer systems on protein stability during lyophilization.
- Learn about the preparation and adjustment of histidine buffers for biopharmaceutical applications.
- Investigate the role of pH in protein solubility and stability during formulation processes.
- Explore literature on the lyophilization of monoclonal antibodies and associated pH changes.
USEFUL FOR
Researchers, biochemists, and pharmaceutical scientists involved in protein formulation, particularly those working with monoclonal antibodies and lyophilization techniques.