Crystal Pharmatech, a technology-driven, solid-state CRO based in Suzhou, China, has partnered with Pennsylvania-based CRO Particle Sciences, which focuses on the formulation and support of advanced drug delivery solutions.
The partnership, one of many Crystal Pharmatech is forging with research driven organizations, combines a level of expertise previously not available to CROs that will increase the success rate for the development of insoluble pharmaceutical compounds.
Over the past five years, approximately 65% of pharmaceutical compounds under development have been sparingly soluble to practically insoluble in water. This has led to the need for more innovative formulation and solubilization techniques. As scientific complexity of drug development increases, finding the appropriate CRO to bring about the optimal development path for both drug substance (API) and drug product (formulation) is of utmost importance. Crystal Pharmatech has extensive experience selecting the appropriate solid phase of a wide range of compounds and a proven track record in providing fundamental material property evaluation, screening, evaluating and selecting the optimal form for pharmaceutical development.
Particle Sciences has more than two decades of experience in formulating active pharmaceutical ingredients (APIs) and multiple delivery/formulation formats. It is able to identify common obstacles in drug product development and provide a resource of delivery technologies to address these obstacles.
"Whether the best way to develop your product is a co-crystal or nano-suspension depends on the material properties of your drug and the delicate interplay between API and formulation development," said Alex Chen, CEO of Crystal Pharmatech.
Robert Lee, vice president, pharmaceutical development at Particle Sciences, said, "Often, a client will work with a CRO to find a path forward for API development only to realize that the chosen path is unacceptable for formulation development and, as a result, the project goes over the allocated time and budget."
Both Crystal Pharmatech and Particle Sciences vetted a number of potential partners prior to aligning with each other, and each company will utilize the other's core expertise to seamlessly offer clients the optimal program for their drug candidates.