Insulin glargine is a long-acting recombinant human insulin analog produced in *E. coli*. It differs from native insulin by a glycine substitution and additional arginine residues, leading to altered solubility and extended activity. The USP standard supports identity testing, potency assays, and impurity profiling in insulin glargine formulations.

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.

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