Choosing a good contract manufacturer for production of clinical trial material is key for small start-up companies developing innovative drugs. Torkel Gren, Recipharm Pharmaceutical Development, explains what to look for.
Development and manufacture of drug products for clinical trials has never been the most fashionable part of pharmaceutical r&d, and consequently the processes involved are often viewed as simply a formality. Nevertheless, the clinical trial product is extremely important for the success of a project. Delivering the right amount of trial product in the right timescale is a prerequisite for completing a study on time. Moreover, if the dosage form does not release the right amount of active ingredient to the right place at the right time this will have a negative impact on the trial results.
A further concern is that if the dosage form and the package are perceived as inconvenient by the subjects it may lead to drop-outs from the trial, further delaying its completion. And last but not least – even though there may be opportunities to improve a clinical trial product before it reaches market – the commercial potential of a product will be affected by characteristics of the dosage form, such as convenience, shelf life and manufacturing cost.
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