Opexa Therapeutics' Woodlands, Texas office/research facility

Opexa Therapeutics' 10,200 sq. ft. office/research facility is located at 2635 N Crescent Ridge Drive in The Woodlands, TX. This location provides space for pipeline development through Research & Development; a specialized Flow Cytometry and Microscopy lab; support of clinical trials with GMP manufacturing Suites; Quality Systems management with Quality Control Laboratory, Regulatory Affairs, Quality Assurance; as well as administrative support space. The facility is leased for a term of ten years (through September 30, 2022) with two options for an additional five years each at the prevailing market rate.

The 800 sq. ft. GMP (Good Manufacturing Practice) manufacturing area has capacity to manufacture cellular therapy material for Phase I, II, and III clinical trials and renders services under the FDA (Food and Drug Administration) guidelines for GMP thus assuring 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 Therapeutics with an integrated GMP-compliant operation. The Quality Control lab and the Quality Assurance provide support to the GMP manufacturing process.

The Quality System Management team consists of Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs(RA) staff. Their centralized office area provides space for QSM staff and their related activities as well as centralized storage of all valuable documents. There is also a small conference area for quality reviews. QA is responsible for overall quality of all aspects of the operation from both the manufacturing and clinical facets of operation. This group is responsible for review and approval of all manufacturing and processing records from the laboratories and assuring compliance with the applicable regulations and our own SOPs (Standard Operating Procedures). In addition, QA oversees the receipt and release of all supplies to the GMP laboratory. QC group carries out release testing for clinical material to ensure they fall within the specifications set for their characterization and quality release as established in FDA guidelines. QC also conducts the environmental monitoring of the GMP laboratory and oversees the radioisotope assay lab. Starting clinical material as well as reagents and supplies enter the controlled GMP lab through the pass through after being wiped down to minimize particulate matter. Utilizing a pass through provides a means of accessing the space without having to gown and un-gown numerous times.

RA is an integral part of the team, ensuring compliance with FDA and other regulatory requirements in all stages of clinical development. The regulatory affairs staff prepares, manages, and maintains regulatory submissions including clinical trial related documents, facilitating submissions to the FDA, IRA, and other regulatory entities. They also provide insight into protocol design which results in studies that meet regulatory and scientific requirements, but are achievable within the desired timelines. The RA staff support to clinical investigators through all stages of the clinical trial process; review and track site regulatory and clinical trial documentation; work closely with our CRO(Contract Research Organization) to assure the collection, evaluation, and reporting of safety information, including serious adverse events and other significant safety events. They are the company's means of overseeing clinical trial progress to ensure compliance with GCP and regulatory guidelines, and maintain the clinical and scientific integrity of each clinical trial.

The 1275 sq. ft. Research & Development (R&D;) area provides space for evaluation of potential new technology, on-going process development of existing technologies, and includes an area for scale-up of processes prior to introduction into the GMP facility. The space and equipment supports the tissue culture and molecular biology activity necessary to fully develop and implement new techniques or processes that expand our core technologies. Scientist and technical staff in the R&D; lab formulate and analyze pre-clinical models, and optimize the conditions and techniques for making the clinical protocol a reality. They address the issues involved in scaling up techniques to meet the volumes associated with clinical trials, developing a closed system for the techniques, and translate this knowledge to the manufacturing staff. The R&D; staff also develops and executes techniques to monitor the efficacy of clinical trials.

The Cellular Analysis Lab supports both the research and manufacturing activities. The lab consists of a full-scale histopathology core facility as well as immunohistochemical/fluorescent staining and flow cytometry. In addition, the lab has a Leica DMIRE2 inverted fluorescent microscope equipped with filters suitable for both Alexa dyes and Q-dots. We also have full digital photography capacity and image analysis software. Phenotypic analysis is performed using a Becton-Dickinson FACSCalibur cytometer that can detect up to four colors and two size parameters.

We also have an access controlled area for the centralized Cell Banking of both research and clinical material and the Gamma Cell 300 Irradiator. This area also provides us with a central vacuum system distributed to all laboratory areas, and centralized CO2 storage and distribution. All critical equipment in the facility is wired to a centralized panel which allows for quick connect to an emergency generator.