GMP Manufacturing facilities were constructed according to specifications set by Code of Federal Regulations Title 21, Sections 210 and 211. Validation of clean rooms and utilities were conducted in accordance with established standards and facilities have been qualified and utilized for therapeutic manufacturing.
There are two GMP manufacturing sites of 1300 and 4000 square feet respectively. Although each site is primarily dedicated to either biological or cellular products, both facilities have been designed to accommodate both production venues to allow flexibility and maximize product throughput. Non-clinical production, quality control, and other support activities are performed within 2000 square feet of non-GMP laboratory space.
Equipment allows production at scales that readily exceed the capabilities of most research laboratories, and as required provides the added benefit of clinical cGMP compliance that would not otherwise be available to investigators. For production of biologicals, bulk cell culture capacity can range up to the equivalent of 100 liters in various culture formats including fully automated fermentor/bioreactor vessels.
Equipment is available to harvest either bulk-conditioned media or cells depending upon project needs. In most cases bulk conditioned media is harvested followed by purification. Purification may consist of multiple steps including affinity, ion exchange, ultra filtration, and diafiltration.
The resource generally takes a conservative instrumentation approach to allow for maximum product yield in conjunction with moderate capital outlay, ease in instrument repair/maintenance, minimal staffing and simplicity to facilitate Food and Drug Administration (FDA) compliance.
Manufacturing suites supporting the production of cellular therapeutics are equipped with biological safety cabinets and numerous double stack incubators. Other major equipment includes floor and table top centrifuges, cell washers, sterile connecting devices and large scale cell enrichment devices from Baxter and Miltenyi Biotec.
In conjunction with these core equipment capabilities, the Therapeutic Manufacturing Unit maintains a separate well equipped quality control (QC) laboratory space to provide product characterization and safety testing capabilities, such as automated cell counts, flow cytometry, sterility, and endotoxin, as required by the FDA for clinical studies.
All manufacturing activities are conducted using approved written procedures performed by trained, qualified personnel in accordance with cGMP and current Good Tissue Practices (cGTP) guidelines. Quality assurance oversight and review is provided to assure regulatory compliance and safety of therapeutic products.
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