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.

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Quality Control

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

Product specific method development, transfer, qualification and validation:
  • HPLC/UPLC
  • 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

More Fill/Finish Services