Manufacturing

State-of-the-Art Facility & Personnel

Manufacturing Process

Patient screening includes confirmation of the tumor mutation and human leukocyte antigen (HLA). The tumor mutation is identified through sequencing of a tissue biopsy (solid or liquid). HLA testing requires a simple blood draw. These two pieces of information are utilized to screen the patient for a “match” to the Alaunos TCR library.
Alaunos selects one of the pre-manufactured TCR DNA plasmids from its library which corresponds to the patient’s mutation and HLA.
A portion of the patient’s white blood cells are collected through a peripheral blood leukapheresis. The cells are then sent to the Alaunos manufacturing facility in Houston, Texas for manufacture of the TCR-T cell product.
The Alaunos proprietary nonviral gene transfer platform called Sleeping Beauty is utilized to genetically modify the patient’s T cells (both CD4+ and CD8+) using the TCR plasmid.
The genetically modified T cells expressing high levels of the TCR are expanded to produce the patient-specific TCR-T cell product.
The TCR-T cell product is formulated from the manufacturing process and cryopreserved. The cryopreserved product is stored in a liquid nitrogen until infusion day.
Once the patient is ready, the TCR-T cell product is thawed and infused at the clinical site.

Manufacturing Capabilities

Alaunos’ Phase 1 TCR-T cell products are manufactured in its state-of-the-art cGMP facility near the Texas Medical Center in Houston, Texas. The facility is staffed by Alaunos personnel and is fully operational for manufacturing and release of clinical product.

We are committed to improving our workflow through process and analytical development in parallel to our manufacturing team. The ability to rapidly move improvements from the lab into the cGMP suite enables our manufacturing processes to remain at the cutting-edge during the early phases of clinical development and position the program for commercial scale.