Stability & Release Testing
Stability testing data is a critical component of any drug development program. Not only do you need to know how long your product lasts under routine conditions, but determining how robust your product is under stressed conditions is equally important. When it’s time to bring product to market release testing becomes paramount. Meeting specific testing criteria will make or break your lot run. Trust your testing to HBS, and rest easy knowing your product is getting professional attention.
Stability Testing Programs
Haemtech can implement and perform stability testing procedures for your biopharmaceutical or proteinaceous IVD reagent. Real time and accelerated stability programs are offered as is shelf life determination. Using client-defined, compendial or custom developed and validated methods, we provide stability storage and testing under a variety of conditions that meet ICH guidelines.
Release Testing Programs
A variety of analytical methods
is available to assist in your biopharmaceutical batch release. Whether you have a pre-defined release testing protocol or need assistance in developing methodology and acceptance criteria HBS can help. Rapid turnaround and efficient sample management is assured.