At the root of this challenge is a vertically integrated structure with ‘make’ functions separated from ‘test’ functions.
Formulation development under the current industry structure typically comprises the identification of formulation prototypes, which are then screened in preclinical species to select candidates for clinical assessment. Manufacturing processes for these candidates must then be scaled-up to generate the product to support extensive stability studies that drive regulatory submissions, with the remaining material packed, labelled and shipped to a clinical site for evaluation. This process can take 12–18 months to complete and requires significant investment before the product is known to meet the drug delivery need.
Translational Pharmaceutics has enabled a reconfiguration of conventional formulation development and optimisation processes, addressing gaps in observed human performance, by proceeding directly to clinic without conducting poorly predictive preclinical pharmacokinetic investigations. This data-driven, streamlined formulation development approach — termed RapidFACT — allows drug products to be screened iteratively in human subjects, dramatically increasing the accuracy of formulation evaluation and selection.
Make versus test
It is widely reported that up to 70% of new chemical entities (NCEs) entering drug development programmes possess insufficient aqueous solubility to allow adequate and consistent gastrointestinal (GI) absorption to ensure efficacy. In addition, industry’s desire for once-daily oral delivery to ensure a competitive position for new drugs, or to reposition existing products, is becoming ever more important. These challenges place a significant focus on formulation development and CMC teams to deliver the best possible drug product.
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