Avoid delays, choose an experienced partner for your stability testing.
From development and manufacture of drug substance and drug product to stability studies, including cytotoxic, radiolabeled, and controlled substances, we are your partner of choice. We can fulfill all your needs, from protocol generation through to study end.
Our service is supported by state-of-the-art facilities, including walk-in, ICH-compliant stability chambers and several smaller, reach-in units. ICH-compliant photo-stability testing equipment is also available to study the effects of light stress on materials and packaging.
We work collaboratively with each customer to ensure the setdown of their stability samples goes as planned, to fine details such as labeling, pack orientation, and storage conditions. Through close consultation, we ensure that the required protocols are clear and concise to match client expectations.
Our colleagues and internal systems are well established to ensure effective sample management, providing a complete chain of custody. Designated stability personnel within Drug Product who control all sample management during stability studies, constantly monitor the stability chambers, and can act as a point of contact for clients. Dedicated processes are in place to ensure complete tracking of samples from receipt, throughout stability storage to the study termination.
For those clients wishing to avail themselves of our extensive testing capabilities, we offer a full range of analytical testing to meet the most challenging of needs. We have the capabilities to perform a wide range of pharmacopoeial testing, physical characterizations, and chemical testing for both drug substances, drug products, and radiolabelled compounds. In addition, we can provide method optimization/ qualification services to produce analytical methods tailored to the stability testing of a customer's material.