Monoclonal Antibodies

Monoclonal Antibodies, used both as parenteral therapeutic agents and as reagents in a drug substance manufacturing process, represent a core product development emphasis in biotechnology.

Monoclonal Antibodies for either the therapeutic or reagent application may be expressed in bacteria, fungi (yeasts and molds), or mammalian cell lines.

Safety concerns may vary according to both the application for the antibody and the cell line selected for its expression system.

• 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

Our integrated Biopharmaceutical Services Monoclonal Antibody Program will help you accelerate your efforts to assure product safety and to meet FDA guidelines.

Reference: Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing, March, 2001

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