Formulation development
Managing the development of the drug substance route of synthesis and manufacturing process for an innovative molecule in the preclinical phase
Scope of work:
Chemistry Manufacturing Control Formulation development Project management Selection and supervision over a CDMOThe project involved developing a manufacturing method for a drug substance that is a candidate for an innovative drug product.
Scale-up and implementation into commercial production of a technologically complex drug product.
Scope of work:
Formulation developmentThe project concerned scaling up and implementing the production of an oral film-coated tablet. Technical difficulties resulted primarily from the specific properties of the active substance, which constituted approximately 90% of the tablet composition.
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