A major challenge when taking drug candidates from clinical studies to market is finding robust product formulations that can be used from early stage studies through product commercialization. Early stage clinical studies frequently use Active Pharmaceutical Ingredient powders or oral suspensions that may have limitations in stability or bioavailability, necessitating potentially time-consuming, costly reformulations as doses are established during later development trials.
Frontida Biopharm was formed in 2016 with the acquisition of three Sun Pharma facilities in Philadelphia, Pennsylvania and Aurora, Illinois to provide co-development and commercialization services to pharmaceutical partners. These three cGMP sites cover 335,000 square feet, with an annual capacity of 3 billion capsules and tablets. Our services include determining optimal stable product formulations for drug candidates, as well as providing manufacturing, packaging and logistical support for commercialized products.
Cost-Saving Proprietary Product Formulations
We have two specialized product formulation platform offerings. The AdaptDoseTM flexible dose technology platform allows us to combine 2–3 populations of mini-tablets, beadlets, liquids or granules into a single capsule. Each type of mini-tablet or beadlet contains a single compound, allowing the quantities of each compound to be weight-adjusted independently in the capsule. One application of this technology is for formulations required for adaptive clinical studies and clinical dose escalations, where the formulation can be adjusted easily by changing mini-tablet/beadlet quantities in the capsules while the clinical study is in progress. Since the formulation is modular, there are no additional costs for formulation development efforts or stability studies, thereby reducing project time and costs by about 30%.
AdaptDoseTM is also useful for extended-release (ER) formulations. Mini-tablets and beadlets can be coated with various pH-sensitive polymeric or enteric coatings that allow different biological release rates. Coatings can be designed to dissolve portions of the formulation populations at specific pH values in the gastrointestinal tract and thus be released in a staggered fashion as the formulation particles travel from stomach to small intestine to colon.
Frontida’s DuraGran® process is a patented technology for producing controlled release or taste-masked beadlets or granules. The DuraGran® process utilizes high shear granulation, fluid bed drying and continuous milling and classification to create granules of a desired particle size distribution range that can be coated and compressed into tablets or filled into capsules. The process can handle hundreds to thousands of kilograms of DuraGran® material. Compared with spheronization and extrusion, this technology may enable reduced production costs, energy requirements and in-process monitoring with an efficient transition from lab to commercial scale.
Frontida’s Collaborative Approach
Frontida has a very strong R&D focus, with an R&D team of more than 40 scientists, 70% of whom have Ph.D.s or Master’s degrees in their area of expertise. The team has extensive industrial, pharmaceutical and academic experience. We also have a technology bridging group of engineers who work with the R&D team and production areas to ensure that formulations work on a commercial scale. These teams collaborate with scientific thought leaders at sponsor companies to set and accomplish scientific and business goals. This approach brings value to commercial projects by establishing strong science from the beginning and building that into processes. A significant advantage is that these collaborations can result in patentable outcomes that can strengthen and extend a client’s product positions in the market.
Frontida is interested in forming partnerships ranging from fee-for-service for quality work for larger pharmaceutical companies, to helping smaller companies find funding and partnering with them for win–win outcomes. The management team has extensive experience with a broad range of pharmaceutical and biotech companies, including many U.S. and Chinese firms who have brought products to these markets.
Integrated Development, Manufacturing and Packaging
Frontida currently manufactures 20–25 products for a range of clients, with the opportunity to grow to about 3 billion tablets and capsules per year. These are supplied as finished products and sent directly to client distribution centers, with full bottle packaging, serialization and labeling services. We can also provide packaging-only services, analytical services and method validation to support clients as required. The expertise developed over our team’s many years in the market provides a seamless, efficient process for product development and commercialization.