Beginning in the preclinical phase of drug development, the Manufacturing Division works with each PI and provides technical expertise for developing GMP-compliant drug manufacturing strategies for his or her investigational products. Working with each PI, the Manufacturing Division develops initial drafts for manufacturing SOPs, for which procedures are later validated by the QC Division and approved by the RAQAD. The Manufacturing Division prepares the initial small scale lots of clinical-grade (GMP) investigational products required for toxicology studies, which will be included in the initial IND application. For production of drugs for clinical use, it is the responsibility of the Manufacturing Division to perform manufacturing scale-up for batch production and develop solutions to process problems during this phase. This division will generate, review, and provide revisions of clinical manufacturing SOPs, master batch records, change controls, and manufacturing deviations. It will optimize manufacturing processes and identify process limits. Therefore, the goals of the Manufacturing Division are as follows:

1) To generate GMP compliant drug products for toxicology testing during the preclinical drug development phase;

2) To generate drafts of manufacturing standard operating procedures (SOPs) for small-scale drug production;

3) To develop, perform, and trouble-shoot scale-up manufacturing for generation of clinical batch products;

4) To provide a documented and traceable record of all clinical manufacturing procedures to establish batch evidence of GMP compliance.

5) To optimize manufacturing conditions to ensure consistency in batch products.

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