L-Histidine USP EP BP JP ChP

Benefits of L-Histidine in mAb Stabilization:

Monoclonal antibodies and other protein based biologic therapeutics are inherently susceptible to degradation, aggregation, and loss of activity during manufacturing and storage. L-Histidine emerges as a key player in addressing these challenges due to its unique chemical properties.

Buffering Capacity

L-Histidine exhibits an excellent buffering capacity, particularly at pH 7.4, making it an ideal amino acid for maintaining a stable environment during the production and storage of mAbs. The pH level is a critical factor influencing the stability and solubility of proteins. By utilizing L-Histidine at pH 7.4, manufacturers create an environment that closely mimics the physiological conditions within the human body, ensuring the stability of mAbs.

Metal Ion Chelation

L-Histidine possesses metal-chelating properties, which can be advantageous in preventing metal-catalyzed oxidation and degradation of mAbs. Metal ions such as copper and iron can accelerate oxidative reactions, leading to the formation of reactive oxygen species. By chelating these ions, L-Histidine acts as a protective agent, mitigating the risk of oxidative damage to mAbs.

Protein Solubility

he solubility of proteins is a critical parameter during manufacturing and formulation processes. L-Histidine, especially at pH 7.4, aids in maintaining the solubility of mAbs, preventing aggregation and precipitation that could compromise the efficacy of the final product.