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Samples of the synthesized product are, among others, tested for enzyme residues. The device used for this analysis works like a sophisticated microwave with temperatures up to 165°C, pressure and acids.
Once the synthesis is complete, the product is tested for various aspects.
This modified and upgraded HPLC equipment is combined with a small reactor inside, which also allows toxicological characteristics of samples to be identified.
The building’s reactors are spread over multiple floors and operated mostly via software interfaces. The team works in shifts to make sure the medicine reaches clinical trial participants on time.
The Drug Product Analysis Team is located in the Physics Garden building.
Each product undergoes extensive testing with a variety of methods. Dissolution testing for drug products is a key method to assess the quality of a drug product.
As the health authorities, such as the FDA and the EMA, have established clear expectations for drug product quality, one being the dissolution of orally administered drugs, the TRD analytics lab evaluates, among others, the time needed until a drug is dissolved in a test liquid that imitates the conditions of a human stomach.