Opexa cGMP Manufacturing

Opexa has developed significant expertise in cellular therapy manufacturing since its formation and has successfully manufactured over 850 personalized doses of Tcelna. All manufacturing is conducted at Opexa's cGMP facility using its proprietary T-cell technology in The Woodlands, Texas.

Opexa has demonstrated its ability to successfully procure, process and distribute Tcelna safely and securely to geographically dispersed patients without difficulty or infringement of any regulation. The Company is currently in the planning and preparation stage for the next clinical study as it pursues its goal of safely bringing one of the most promising MS treatments to market.

Opexa's 10,200 sq. ft. operation and cGMP facility located in The Woodlands, Texas provides space for all research and development and manufacturing capacity for clinical trials; a specialized Flow Cytometry and Microscopy laboratory; support of clinical trials with three ISO7 cGMP (current Good Manufacturing Practice) manufacturing suites.


Tcelna is manufactured using Opexa Therapeutics' proprietary method for the production of a subject-specific T-cell immunotherapy, ImmPath™, which encompasses the collection of blood from the MS subject, isolation of peripheral blood mononuclear cells (PBMC), generation of an autologous pool of myelin-reactive T-cells (MRTC) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP) , and the return of these expanded, irradiated T-cells back to the subject. These attenuated T-cells are reintroduced into the subject via subcutaneous injection to trigger a therapeutic immune response consisting of anti-idiotypic cytotoxic and regulatory T-cells, to limit the frequency and function of T-cell dependent autoimmunity directed against myelin.

The commercial process will be built on the existing streamlined backbone, which has been established based on several of the well developed worldwide logistics and distribution channels that have become standardized and regulated over the past 10-15 years by the FDA and practiced on a large scale across the industry by agencies such as the American Association of Blood Banks and the American Red Cross.

Tcelna is being developed to serve the MS population as follows:

  • Patients will meet with primary physician for initial screening. A blood sample will be taken and sent to Opexa's laboratories (or contract clinical laboratory) for myelin-reactive T-cell screening.

  • Key patient information is entered into ImmForm™, an online management system which will help all parties monitor product shipping and treatment scheduling. The patient's physician and Opexa have access to the system.

  • Screening results will be communicated to physicians and a prescription will be written for a directed blood draw for patients with positive myelin reactivity.

  • Patient will take prescription to a licensed blood center (part of Opexa's contracted network) where the blood is drawn and shipped overnight to Opexa's facility.

  • Upon receipt of the blood sample, Opexa will enter the patient into an online management system which will set the treatment schedule. The online management system will feed information to the facilities' manufacturing resource planning (MRP) system for accessioning and manufacturing planning purposes.

  • Prepared product will be shipped first priority overnight to the physician office, home health care or specialty pharmacy for injection into patient.

  • Each patient's epitope profile will be monitored annually allowing for optimization and personalization of subsequent Tcelna preparations.