Services :: cGMP Support
The U.S. Food and Drug Administration (FDA) maintains a set of guidelines for current Good Manufacturing Practices (cGMP). Vista Biologicals offers the following services to support compliance with these guidelines:

• Cell Line Characterization
• Cell Banking
• Cell Storage
• Preparation of Batch Records
• Pre-IND Support
• Reference / Stability lots
• Formulation / Stability studies

cGMP Topics
To learn more about various aspects of the cGMP guidelines and how Vista Biologicals can help you meet these requirements, select a topic below. Note: You will need the free Adobe Reader (available at adobe.com) installed on your computer to view these documents.

• Characterization of Cell Lines
• Characterization of a Monoclonal Antibody Bulk Reference Lot
• Characterization of a Recombinant Protein Bulk Reference Lot
• Lot-to-Lot Quality Control Monitoring of Monoclonal Antibodies (PTC)
• Lot-to-Lot Quality Control Monitoring of Recombinant Proteins (PTC)