Investigational New Drug Services
The processes of translational medicine, whereby new therapeutic drugs are taken through development, FDA regulatory review and clinical trials, are not inherently a do-it-yourself prospect for most Principle Investigators (PIs). Accordingly, the Cancer Immunotherapy Program provides services and support to basic researchers and clinicians who are not familiar with the regulatory processes governing the development and manufacturing of new drugs.
The program's cGMP facility provides a centralized service for the production, manufacture, and quality control validation of cellular-based therapeutics, which complies with FDA regulations requiring that all manufactured drug and biological products used in clinical trials meet the standards of current Good Manufacturing Practice (cGMP) and are safe and free of contaminants.
The personnel of the Quality Control and Manufacturing Divisions will work with investigators from the pre-clinical research phase through early drug development phase and are committed to providing their knowledge and expertise in the areas of biotechnological engineering, pre-clinical validation, large-scale manufacturing, product characterization, and evaluation of safety, toxicity, activity and clinical impact of cell-based biotherapies.
Additionally, the Regulatory Affairs & Quality Assurance Division (RAQAD) provides an independent Quality Assurance Service for all investigational new drug products manufactured under FDA Investigational New Drug (IND) applications to ensure that each PI's translational research complies with FDA regulations for safety by meeting the standards of current Good Manufacturing Practice (cGMP). To this end, RAQAD provides consultative services to PIs for: 1) FDA IND submission support and documentation; 2) adapting general compliance strategies (cGMP); 3) generating standard operating procedures for product manufacturing and testing; 4) devising product tracking and labeling methods; 5) resolving regulatory compliance issues; and 6) validating product packaging and shelf-life.
For more information on the goals and services of each cGMP division: