Protein Formulation and Process Development along with GMP Fill Finish Services from a Single Experienced Source

GMP Testing

Integrity Bio partners with clients to help them bring safe, effective, and FDA-compliant products to the clinic. Testing is conducted according to strict scientific protocols, performed accurately, and completed on time. The laboratory is fully equipped with state-of-the-art instrumentation.

Integrity Bio's quality control laboratory provides:

  1. All environmental monitoring programs required of GMP clean rooms and process utilities
  2. Analytical testing in support of PD activities
  3. Finished product testing
  4. Stability program management and testing

Testing services include:

  • Product specific method development, transfer, qualification and validation
    • HPLC
    • CE
    • UV or protein concentration

  • USP methods on validated equipment
    • Sterility
    • Bioburden
    • Stability
    • Moisture Analysis
    • Endotoxin by Limulus
    • Amebocyte Lysate
    • Total Organic Carbon
    • pH & Conductivity
    • Surface Monitoring