Recombinant Proteins

Paired with advances in cell culture technologies, our exceptional experience in protein and nucleic acid characterization provides a comprehensive and integrated testing and control program.

• Raw Material Testing
• Cell Line Development
• Cell Banking Services
• Cell Storage Services
• Cell Line Characterization
• Release Testing (Unprocessed Bulk and Purified Product)
• Process Validation
• Protein Characterization
• Stability Studies

Charles Rivers’ Recombinant Protein Program will help you accelerate your efforts to assure product safety and to meet FDA, ICH, and CPMP guidelines.

US Sample Submission Forms

Reference: Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody for In Vivo Use, FDA Center for Biologics Evaluation and Research, August, 1996

Reference: Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologics Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability, FDA Center for Biologics Evaluation and research, April, 1992.

Guidance for Industry: Content and Format of Chemistry, March, 1999.

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