The choice of administration route has a profound effect on CMC.

Hardly any drug can be delivered to the patient in all ways and sometimes significant formulation work needs to be done to identify a formulation that maintains stability and allows for the chosen administration route. Changes in administration route during development may require a lot of rework: often stability data needs to be collected again and it needs to be shown that the new formulation results in a similar molecule and safety and pharmacokinetic profile in the patient.

In light of this, it is important that there is close collaboration between the CMC, pre-clinical, clinical, and commercial colleagues so that potential changes can be anticipated. The better the view to long-term plans, the better a CMC strategy can be tailored to anticipate and derisk upcoming changes upfront. The 3D-PharmXchange experts have worked on most traditional administration routes (e.g. IV or oral) and the corresponding drug product presentation, as well as on a number of novel routes (e.g. nasal or intraocular).

Bert-Jan Haijema

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Bert-Jan Haijema

Managing Consultant CMC

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