GMP Release Testing

GMP Clinical and Commercial Release Testing

Prolytix performs GMP release testing for both commercial and clinical trial drug substances and drug products. We test bulk, final product, and in-process materials in our fully compliant, FDA-inspected facility. Combined with our other chemistry, manufacturing, and control (CMC) and drug development services, you’re assured the highest quality from discovery through commercial release.

Release Testing Analytical Methods

With an eye toward rapid turnaround and efficient sample management, we’ll help you develop methodology and acceptance criteria as well as execute a pre-defined release testing protocol. Contact us for:

  • Compendial Methods
  • Osmolality Measurement
  • Residual Moisture Determination
  • HIAC Liquid Particle Analysis
  • Thrombin Generating Assays
  • HPLC/UPLC Methods (Reverse Phase, Size Exclusion, Ion Exchange)
  • SDS-PAGE
  • Clotting Assays (Factor Assays, PT, aPTT, NAPTT)
  • Anti-Drug Antibody Assays
  • Relative Potency
  • Protein Concentration

Method Validation

Prolytix performs validation studies on all tests and processes used to demonstrate product compliance. Speak with one of our scientists to learn more about how we help you demonstrate GMP compliance.

Safety and Security

Prolytix performs strict sample reconciliation against the documentation you provide. After set-down, our environmental monitoring system oversees all storage chambers that house your samples. Backup storage and generators are on-site in the unlikely event of a chamber or power failure.