Crystal Formulation Services boasts a formulation development leadership team with extensive experience and deep expertise in new chemical entity (NCE) drug product development.

Instead of one-size-fit-all platforms or “super-placebo” or quick and rough “fit-for-purpose” formulation approaches in early development, we set right in the beginning the strategy for formulation development specifically for a molecule based on its intended therapeutic area, indication, treatment regimen, available pharmacokinetic and pharmacodynamic data, drug metabolism, molecular profile, API’s physiochemical, biopharmaceutical, stability and mechanical properties.

We then design the formulation composition and process train based on the understanding of material properties of API and excipients such as physical attributes, mechanical properties, functionalities and chemical compatibility. The composition is deliberately designed for the process train in terms of dose range, drug loading, excipient choices and concentrations of every ingredient.

Finally, during the drug product development process we strive to keep a line-of-sight (LOS) of the intended clinical goals, i.e., purpose of the molecule as a medicine, as the driver for all relevant decisions. We perform thorough risk assessment prior to key milestones to guide the design of experiment (DOE) study for the understanding of the impact of selected critical API and excipient properties and composition on product critical quality attribute (CQA), the interaction of composition and process, the impact of critical process parameter (CPP) on CQA. This broad knowledge space (KS) allows an appropriate determination of a reliable design space (DS) and an effective control strategy (CS) in drug product manufacturing.

In another word, abiding by the molecule-material-medicine, dubbed the M3 drug product development philosophy, we design and develop the formulation tailor-made for a molecule to meet its intended clinical needs, with good bioavailability, stability, manufacturability, patient compliance and regulatory acceptance while avoiding significant formulation change from early to late development. As importantly, leveraging the experience and expertise of our technical leadership team, we are able to do all these competitively in terms of cost and timeline.