Cytokine Testing – USP <92>

As the focus on regenerative medicine grows, there has been an increase in the number of cell and gene therapies progressing from the lab to the patient’s bedside. The need for high-quality GMP material and accompanying components such as cytokines and growth factors has risen as well. Ensuring the quality and safety of these components is crucial.

PBL Services for Cytokines

Cytokines regulate cell growth, differentiation and other functions and when cytokines are used in manufacturing of cell therapy products they must be qualified to ensure the quality of the product. When qualifying cytokines, PBL follows USP <92> describes procedures and acceptance criteria for cytokines. Purity is tested by gel electrophoresis i.e. SDS-PAGE and identity is determined by western blot. Protein content can be measured by UV Spectrophotometry (A280). We also offer sterility testing per USP <71> and Bacterial endotoxin testing per USP <85>.

Available Services at PBL

• SDS-PAGE
• Western Blot
• UV Spectrophotometry (A280)
• Sterility per USP <71>
• Endotoxin per USP <85>

Read More About Cytokine Testing

• PBL’s Learning Center – Gene Therapy and Cell Therapy CMC requirements for IND Applications
• FDA Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy