Formulation Laboratory Equipment

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. For equipment/supply requirements, responses must include: (1) the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture), as well as (2) the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: 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 2023. In the 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. Purpose and Objectives: The purpose of this acquisition is to acquire the Brand Name or Equal formulation laboratory equipment that meet all salient characteristics.