Clinical and Commercial GMP Stability Testing Services
To move your drug product from discovery to regulatory approval to commercial manufacturing, you must know how your product performs under both routine and stressed conditions. That’s where GMP stability testing from Prolytix comes in.
Prolytix performs all drug stability testing for our partners under strict GMP compliance in our full-service, FDA-inspected GMP facility. You’ll know exactly how your product performs under a wide range of conditions—all of which meet ICH guidelines and the compliance requirements of leading global regulators. We provide testing services for clinical trial materials and products to prepare for commercial release.
Prolytix uses client-defined, compendial, or in-house developed and validated methods to provide compliant stability testing data. We also offer ICH-compliant stability storage on-site.
GMP Stability Testing Programs
Prolytix implements and performs drug stability testing procedures for large-molecule biopharmaceuticals and proteinaceous IVD reagents. We offer real-time and accelerated stability programs and shelf-life determination.
GMP Storage Services
Do you need the resources to securely store your clinical and commercial materials? Prolytix can help your team control overhead costs and maintain product integrity with reliable stability storage services. Our GMP storage facility provides ICH-compliant storage under a wide range of temperature and humidity requirements. Safeguard your progress with backup storage and on-site generators in the unlikely event of a chamber or power failure.