Adaptimmune selects Biolife's freeze media for T-Cell therapy trials

Oxford, UK and Philadelphia, US-based biotech Adaptimmune is using its T-cell therapy platform to develop therapies for cancer and infectious diseases, and the firm has selected Biolife’s CryoStor freeze media for its myeloma therapy currently in phase I/II clinical trials.

The engineered T-cells are frozen following manufacture and prior to infusion into the patient, Dr. Gwendolyn Binder-Scholl, Executive Vice President at Adaptimmune, told Biopharma-Reporter.com, as an essential step to allow time for safety testing of the cell product.

“Freezing the engineered T-cells in a freezing medium that promotes retention of viability and potency (effectiveness) of the product is an essential aspect of the final cell product,”​ she said.

Whilst CryoStor fulfils this requirement, the medium is also “a complete formula, which improves safety and consistency of the cryopreservation process, and thus facilitates commercial application,”​ she added.

Some companies opt to produce their own freeze media for the step of freezing biopharmaceuticals - in a process Biolife CFO Daphne Taylor told this publication in February​ was called “home-brewed cocktail” - ​which are “created in a laboratory using a traditional approach which is not designed for today’s commercial clinical manufacturing requirements and regulatory scruitiny.”​

However, Adaptimmune’s Binder-Scholl said CryoStor was at least as comparable to these home-made recipes and offered a number of benefits including a reduction in clean room time and improved lot-to-lot manufacturing reproducibility.

Furthermore, “Cryostor is manufactured in a manner that is compliant with Good Manufacturing Practice (GMP), which is a requirement for components used for commercial manufacture,”​ she told us, and “Biolife has submitted the components of Cryostor to the FDA under a Master File submission, which allows the FDA to review and approve use of the medium in manufacture of our clinical cell product.”​

T-Cell Receptors​

According to Binder-Scholl :“Adaptimmune’s product is a patient’s own white blood cells (T-cells specifically) which have been genetically modified with a protein called a T-cell receptor (TCR) which allows the T-cells to recognize the patient’s tumor.”​

The company’s platform enhances the natural TCR affinity to either viral or cancer protein epitopes on the patient’s cells, overcoming the issue of non-recognition of the cancer target and the low affinity of binding from the T-Cell itself.

There are alternative engineered T-cell technologies, the firm’s website says, such as approaches that use Chimeric Antibody Receptors (CARs) to modify T-cells for therapeutic effect. However, the company claim these are limited by the low number of antibody targets available to re-direct the T cell.