The National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health, aims to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Many programs within NCATS enable research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing. One of the focuses of the Division of Preclinical Innovation (DPI), Therapeutic Development Branch (TDB), is to partner with researchers to generate preclinical data and clinical-grade material for use in Investigational New Drug (IND) applications to a regulatory authority. To accomplish these goals, a brand-new formulation laboratory dedicated to preclinical research will be opened in the fall of 2024. In this new laboratory, scientists will research formulation and manufacturing processes to optimize
products’ composition, dosage form, and delivery system to ensure that they are safe, stable, and effective. Specialized Instruments essential for formulation development include equipment for formulation preparation, analytical assay, and stability studies. Moreover, the newly established formulation laboratory will be responsible for producing small-scale engineering batches of the studied drugs. The expertise and insights gained from these manufacturing processes and analytical tests will be shared with our collaborators to ensure the successful production of high-quality, GMP-compliant formulations suitable for human consumption in clinical trials. NCATS is need of a capsule filling machine, as it is an essential instrument for a formulation lab. It allows forPrecise dosage control, ensuring accurate and consistent amounts of active ingredients in each capsule.Versatile and customizable way to deliver formulations.Protecting sensitive or reactive ingredients from external factors such as light, air, and moisture.Convenient dosage form for both researchers in the lab and end-users.Testing of different formulations and formulations of varying dosages.Cost-effective option for certain formulations compared to other dosage forms.Flexibility in choosing the form of ingredients, such as powders, granules, or liquids, offering more options for formulators to work with a diverse range of substances.