Quality Control

The quality control (QC) team is responsible for internal monitoring and ensuring that a quality product is released to the client and that all regulatory requirements are met. QC provides facility environmental monitoring procedures and a full battery of analytical methods.

Our experienced QC staff will:

• Demonstrate product safety
• Characterize the product
  • Protein - SDS-PAGE, stains, HPLC, ELISA, MS, Spectrophotometry
  • Nucleic Acid - Hybridization, PCR, real-time PCR, Sequencing, RFLP, Spectrophotometry
  • Cell-based - Growth curve, doubling time, expression levels
• Demonstrate product lot consistency
• Demonstrate product stability
  • Historical
  • Concurrent with clinical trial
• Monitor the Environment
  • Viable and Non-Viable Air Particles, Settling Plates, Rodac Surface Monitoring
• Monitor Personnel
• Develop & Validate assays

Quality Control and Quality Assurance Services

Additional services are provided by our Quality Team that can help you develop a quality system or enable an FDA submission to go more smoothly. These services are available individually or as part of a project package and include:

• In-process and release assay development
• Specifications and COA development
• Standard Operating Procedure development
• Document Control Development
• Corrective and Preventive Action (CAPA) procedures and other Quality Systems
• Vendor Qualification
  • Raw Materials
  • External Testing Laboratories
• IND Preparation Support; Chemistry, Manufacturing and Control (CMC) section
• Regulatory Agency Audit support

All Quality Systems and processes are outlined in our detailed Quality Manual (please contact us if you would like to know more about our quality systems).