Coagulation Factor VIIa

Recombinant human insulin (rInsulin) is produced via recombinant DNA expression systems and used to regulate blood glucose levels in diabetes mellitus. The USP reference standard supports identity, potency, and impurity profiling of insulin drug substances and biosimilars.

The USP biologics proteins category provides critical standards and reference materials necessary for the development and manufacturing of therapeutic proteins. These proteins, which can be naturally derived or genetically engineered, are essential in treating various diseases and conditions, ensuring that they meet quality, safety, and efficacy standards.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.