… creating
innovative technology platforms that improve efficiencies in pharmaceutical development, structure-based drug design, and continuous flow manufacturing. Using surface science approaches to modify the ubiquitous containers used in laboratories and manufacturing, DeNovX can improve the formation of crystalline solids with slot-in products that fit existing workflows.

Approximately 90% of active pharmaceutical ingredients (APIs) are crystalline, making DeNovX’s tools broadly relevant in reducing the challenges of generating crystalline APIs. DeNovX’s technologies have reproducibly shown 50% reductions in crystallization onset times for various APIs, potentially saving 3-6 months in API solid form development in a market for which these R&D time reductions have significant tangible value.

Approximately 85% of protein crystallization trials fail to produce crystals for structure-based drug design, resulting in millions of failed experiments annually for each high throughput screening facility. Based on replicate, controlled studies with more than 12 proteins of different classes (e.g., benchmarks, challenges, soluble, membrane, SARS-CoV-2 related, etc.), DeNovX has demonstrated an average 3-fold increase in protein crystallization hits while producing 2.5-fold more crystals in 40% less time, with preservation of X-ray diffraction quality. These benefits can be anticipated to have a sustained and powerful impact on structural biology and structure-based drug design.

DeNovX is also developing a patented continuous flow manufacturing antisolvent crystallization approach for APIs, and the small footprint and process intensification efficiencies of continuous flow manufacturing could reduce pharmaceutical production costs by as much as 50%. Growing acceptance of continuous flow approaches is evidenced by the five FDA approved drugs that are manufactured by branded pharmaceutical companies using continuous flow methods.

DeNovX has a portfolio of 22 issued patents providing broad intellectual property rights in 87% of the world markets having the largest pharmaceutical exports and the highest quality patent laws. DeNovX’s growth engine includes specialty crystallization products, custom services, manufacturing technologies, and licensing opportunities that can enhance the competitive position of pharmaceutical companies, CROs/CMOs, and life science products/services companies.

Think Forward –  to rational crystal form screening and solid form controls.