Facility

Opexa Therapeutics, Inc. (Opexa) operates in a stand-alone facility located on two acres of forested land in the Woodlands, Texas. The company is comprised of over 10,000 sq. ft. of state of the art manufacturing, research and corporate office space allowing for a seamless flow of material, reagents, people and ideas. This location provides ample space for pipeline development through Research & Development; a specialized Flow Cytometry and Microscopy laboratory; support of clinical trials with current Good Manufacturing Practice (cGMP) manufacturing Suites; Quality Systems Management (QSM) with Quality Control Laboratory, Regulatory Affairs (RA), Quality Assurance (QA); as well as administrative support space.

The 800 sq. ft. cGMP manufacturing area has capacity to manufacture cellular therapy material for Phase 1, 2, and 3 clinical trials and follows the FDA (Food and Drug Administration) guidelines for cGMP and Good Tissue Practices (GTP) to assure the quality of the materials and components produced within the facility. The Class 10,000 (ISO Class 7) space is currently configured with a three phase changing area, common corridor for shared large equipment and centralized supply storage, and three tissue culture suites. Each culture suite contains biological safety cabinets which provide Class 100 (ISO Class 2) for direct manipulation of clinical material. The design allows for easy adaptation to a wide variety of manufacturing processes. Room pressurizations and flows of personnel, equipment and material provide Opexa with an integrated cGMP-compliant operation. The Quality Control (QC) laboratory and the Quality Assurance (QA) provide support to the cGMP manufacturing process.