Immunotherapy Program

In This Section

Quality Control Division

In the preclinical phase of drug development, after a drug is identified for its potential therapeutic applications and benefits during the experimental discovery phase, the role of the Quality Control Division is to implement the preclinical development process of that drug toward clinical testing. This development process entails a well-designed and rapid plan to collect quality data, which is required by regulatory agencies, that adequately documents the safety and efficacy of the investigational drug before it can be administered to humans.

When an IND application is submitted to the FDA for review and authorization to proceed with a phase I clinical trial, all pre-clinical studies submitted to provide required information on the composition, stability, activity, efficacy, pharmacokinetics, and safety must have been conducted under Good Laboratory Practices (GLP) established by the Regulatory Affairs and Quality Assurance Division (RAQAD). These GLP provide a documented and traceable record of experimental protocols, analytical methods, data management and summary of all findings.

Once an IND application is filed and the product is reviewed and released from clinical hold by the FDA, all manufacturing of clinical drug lots must be conducted under Good Manufacturing Practices (GMP). GMP provide a documented and traceable record of all manufactured drug lots showing that all manufacturing and testing procedures and equipment have been validated and qualified, respectively, as suitable for producing drug lots that conform to established standards for ensuring patient safety. Therefore, the goals of the QC Division are as follows:

  1. To validate analytical methods and raw materials indicated for use by the RAQAD in the preclinical phase of the PIs' projects;
  2. To ensure that preclinical studies carried out by PIs are performed in accordance with validated GLP compliance;
  3. To develop, perform, and trouble-shoot scale-up manufacturing for generation of clinical batch products;
  4. To develop critical control parameters for the scale-up of clinical drug production, which is performed by the Manufacturing Division;
  5. To verify that each drug lot meets RAQAD-approved master drug specifications for clinical release using validated QC analytical methods.

To contact Quality Control or Regulatory Affairs, please call 401-456-5783.