GMP Stability Testing and Storage

GMP Clinical and Commercial Drug Stability Testing

To move your 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 stability testing from Prolytix comes in.

All Prolytix drug stability testing follows strict GMP compliance and takes place 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. We provide testing services for both clinical trial materials and products readying for commercial release.

Prolytix uses client-defined, compendial, or in-house developed and validated methods to provide compliant stability testing data. We also provide ICH-compliant stability storage on-site. Contact us for details.

Stability Testing Programs

Prolytix implements and performs stability testing procedures for large molecule biopharmaceutical and proteinaceous IVD reagents. We offer real-time and accelerated stability programs as well as shelf-life determination.

GMP Stability Storage 

Do you lack the resources to securely store your clinical and commercial biologic materials? Control overhead costs and maintain product integrity with GMP stability storage from Prolytix. Our GMP facility provides ICH-compliant storage under a wide range of temperature and humidity requirements. Backup storage and generators are on-site in the unlikely event of a chamber or power failure.

Don’t let storage constraints compromise the safety and efficacy of your large molecule drugs and drug products. Contact Prolytix to discuss your stability storage needs.