Pegfilgrastim for Bioassay

Pegfilgrastim is a pegylated form of filgrastim, designed to extend serum half-life by reducing renal clearance. It stimulates neutrophil proliferation and differentiation. The USP bioassay standard supports potency testing, bioactivity validation, and pharmacodynamic assessment of pegfilgrastim preparations.

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.