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The GMP Core at the Baylor Institute for Immunology Research (BIIR) is an FDA-regulated core that develops, manufactures, tests and ships investigational autologous dendritic cell vaccine products for therapeutic use in human phase I/II clinical trials to treat melanoma, HIV, pancreatic cancer, breast cancer and hematological malignancies such as lymphoma.
The development work that the GMP Core performs is critical to obtain the required information and data needed to submit an Investigational New Drug Application (IND) to the FDA to conduct clinical trials. Some of the activities that the core provides in the development phase include:
- Months of experiments to define the vaccine product for each clinical trial
- Manufacture and QC release testing of control batches for each vaccine product
- Compile lab data from control batches and other developmental work
- Create study-specific lab SOPs and lab forms for the trial
- Create study-specific clinical intake forms for blood and tissue sample biopsies
- Revise study SOPs and forms per revision requirements
- Gather reagent and material COA and peptide QC release data
- Compile Chemistry, Manufacturing and Control (CMC) information for IND submissions
- Respond to FDA review questions
Once the IND is obtained for a clinical study, the GMP Core manufactures and QC releases the product, stores the product, ships the product to the clinic for human use, and maintains the manufacturing facility, equipment, supplies and support facilities as required by FDA GMP guidelines and regulations. This includes preparing the manufacturing data and reports needed for annual FDA reviews.
The dendritic cell vaccine manufacturing facility is a dedicated cGMP facility on the first floor of the BIIR Lieberman building. The facility consists of a suite of two Class 10,000 clean rooms and support space (one-way flow clean room gowning entrance and exits, access corridor, primary gowning room and storage areas). The clean rooms are designed for a single pass of air through each clean room with no mixing of air between the clean rooms or support spaces. Both clean rooms are equipped with 6 individual incubators (one incubator is designated for only one patient vaccine batch at a time, thus allowing the simultaneous manufacture of 12 individual vaccine products), a biosafety cabinet (Class 100), centrifuge and elutriator. The environmental and equipment control and monitoring is performed by an automated Rees System that is calibrated and validated annually. A card reader at the entrance to the GMP vaccine manufacturing facility restricts access to authorized personnel.
To date, the GMP Core has been involved in the manufacture and QC release of dendritic cell vaccine products for 10 phase I/II clinical trials.