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 HTI, and rest easy knowing your product is getting professional attention in a full, FDA-inspected GMP facility.
Stability Testing Programs
HTI can implement and perform stability testing procedures for your large molecule 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 HTI can help. Rapid turnaround and efficient sample management is assured.
Safe and Secure Sample and Data Management
You can rest assured that your samples and data are in good hands for the duration of your study. Our safety program begins with stringent sample reconciliation against the documentation provided by you. After set down, our environmental monitoring system keeps an eye on all storage chambers housing your samples. In the unlikely event of a chamber or power failure back up storage devices and generators are on site. Your data is similarly secured on multiple on-site servers that are maintained in a controlled environment, and with weekly off-site, secure storage of tape back-ups. Data packets are then transferred to you via a dedicated, secure FTP site so there is never a question of integrity.