As a new molecule progresses through drug development, the way it is formulated as the drug product or dosage form will change for it to successfully achieve key clinical milestones.
In early development, the first-in-human (FIH) clinical trial is often a single-center study and typically involves dosing a small number of healthy subjects over a short duration of days or weeks. In this study, the drug is administered in increasing doses and as such, a “fit-for-phase” drug product with high dose flexibility is often used, such as a simple solution, suspension, or powder-in-capsule.
This type of drug product can usually be prepared on-site, at a small scale, and with limited stability studies and analytical release testing. Simple pharmacy preparations may be sufficient for FIH clinical studies, but when moving beyond Phase I into later stages of clinical development, these products are unsuitable for both patient convenience and scalability to meet larger batch size requirements for Phase II trials.
Scaling drug product for Phase II-III clinical trials
Subsequent Phase II-III clinical trials involve a larger number of patients and often take place at multiple clinical sites, across states and countries, over a longer period. To support these trials, the development team will need to bridge to an optimized drug product, such as a solid oral dosage form like a tablet, to ensure patient compliance and suitability for shipping globally.
Product batch sizes manufactured to support Phase II and Phase III trials need to increase. Later, if the molecule is successful in late phase clinical studies, drug product batches can be scaled to commercial supply.
Requirements for different drug product formats at each stage of development can result in delays and budget overruns, if not managed well. CMC delays can be prevented by careful planning, earlier technology considerations in the formulation design process, and considering integrated CRDMO drug development activities to remove time and cost of managing multiple CRO and CDMO providers.
Bringing new molecules to market as quickly as possible
To improve R&D productivity and bring new molecules to market as quickly as possible, drug companies are actively seeking new ways of streamlining drug development using alternative outsourcing models. Using the Translational Pharmaceutics® platform, a novel approach for integrated drug development, Quotient Sciences coordinate drug product manufacturing requirements with a clinical development plan, making and testing formulations in a streamlined way to gain time and cost efficiencies.
Druggability Technologies (DRGT; now part of Tavanta Therapeutics) was a specialty pharmaceutical company dedicated to the development and commercialization of high-value proprietary drugs to deliver measurable improvement in clinical utility. Translational Pharmaceutics® was used to advance the development of DRGT-46, a fast-acting formulation of celecoxib.
Earlier access to clinical data helped DRGT drive formulation selection in real-time, allowing the company to efficiently bridge from a Phase I drug product, up to a dosage form suitable for patients as they were entering late-stage clinical trials.
Continue reading to learn more about how Translational Pharmaceutics® was applied to DRGT-46, or contact us today if you have any questions about how our integrated CRDMO solutions can help advance your next drug program.