The overall objective is for the preparation of bulk chemicals/drugs that are needed by the NExT and other programs. The required materials are not readily available in the quality or quantities needed from the original supplier or on the open market. Major aspects of the contract work scope will include: (1) GMP process development to transform a laboratory scale to larger scale production;(2) synthesis of bulk chemicals/drugs on multi-grams to multi-kilograms scale as needed;(3) analysis for ensuring the purity, identity and quality of the prepared compounds including QA/QC for the GMP batches;and (4) additional studies such as solubility/stability when required. Technical reports submitted by the Contractors may be used to support IND applications to the FDA.
