GMP Release Testing Services

Clinical and Commercial GMP Release Testing Services

Prolytix provides GMP release testing for 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 early-phase clinical development through commercial release.

Release Testing Analytical Methods

Our team will help you develop analytical methodology and acceptance criteria, as well as execute predefined GMP release testing. With an emphasis on customer success, go with Prolytix for fast, reliable turnaround and efficient sample management. 

  • Compendial Methods
  • Osmolality Measurement
  • Residual Moisture Determination
  • Excipients including pH Modifiers, Tonicity, Amino Acids, Preservatives, Chelators, Surfactants, Inhibitors
  • 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

GMP Testing & Method Validation

Prolytix performs validation studies on all tests and processes to demonstrate product compliance. Speak with one of our scientists to learn more about our commitment to GMP compliance and robust method validation services.

Safety and Security

Prolytix conducts strict sample reconciliation against the documentation provided to our team. 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.

What is GMP Release Testing So Important?

GMP release testing is a critical quality control process involving physical, chemical, and microbiological tests. These tests are conducted to ensure that manufactured therapeutics meet predetermined specifications before they are released to the market. Batch release testing must demonstrate that products released to the market are consistent with those assessed during the regulatory process.

The importance of batch release testing lies in its ability to verify that manufacturing processes are operating correctly and consistently, ensuring the quality and safety of the products. 

The amount of testing required for each batch depends on various factors, such as identified risks, variability in the manufacturing process, and the testing methods applied. A sampling procedure should be established to ensure that samples taken for analysis are representative of the manufactured batch. 

To minimize the need for extensive batch release testing, appropriate control measures should be built into the manufacturing processes in the early phases of product and process development. Regulators typically require companies to provide suitable batch records, including evidence of the batch testing that has been performed. These records should follow the ALCOA standard (Attributable, Legible, Contemporaneous, Original, and Accurate) and provide full traceability of the manufacturing process.

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