Trinity College’s School of Pharmacy has joined forces with Amebis Ltd to roll out a new service that helps drug companies accurately determine the shelf life of their products.
The venture entitled AmTrin ASAP Laboratories, is headed by AMBER principle investigator Prof Anne Marie Healy, and aims to provide Accelerated Stability Assessment Programme (ASAP) services to the pharmaceutical industry.
ASAP is an accelerated ageing process allowing faster and more accurate prediction of product shelf life – 15 of the 20 largest worldwide global pharmaceutical companies are using the ASAP technique.
“AmTrin’s services for the pharmaceutical industry can set the shelf life for products, including tablets, capsules, gels, creams and ointments,” Prof Healy explained.
“Companies can save both time and money by building an accurate stability prediction model for their products and AmTrin can support all ASAP requirements from protocol design to study conduct,” she added.
Accelerated development at Trinity College
AmTrin ASAP Laboratories is the first European service provider with dedicated ASAP laboratories for performing contract ASAP studies and researching new applications.
An ASAP study can be performed, and the shelf life of a product determined, in as little as three weeks, compared to the standard for ICH testing of two to six months.
AmTrin combines the expertise from researchers within both Amebis, AMBER and the School of Pharmacy and Pharmaceutical Sciences in Trinity College Dublin with state-of-the-art equipment to refine and research new applications for the ASAP technique.
The first stage involves exposing the test material to a range of environmental conditions. AmTrin employs the Amebis system to accurately measure the temperature and relative humidity test conditions. The aged test material is then analysed using a range of equipment and finally ASAP modelling software is used to build the prediction model.
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