Brazilian patients will soon have better CAR-T treatments after U. S. nonprofit Caring Cross partnered with government-backed biomedical studies establishment Fundação Oswaldo Cruz (Fiocruz) to identify production capacity.
Maryland-based Caring Cross announced the collaboration in March, explaining that the purpose is to expand the ability to produce chimeric antigen receptor (CAR)-T and mobile gene therapies in Brazil.
As part of the agreement, Caring Cross will provide Fiocruz with the technology, devices and education to manufacture mobile CAR-T therapies, adding the know-how to produce its proprietary lentiviral vectors.
As Executive Director Boro Dropulic, PhD, told GEN, “Caring Cross will provide the strategies to produce CAR-T cells and the vectors to reprogram T cells. “
“Bioreactors are bought from the companies that make them. For example, Scale Ready manufactures GRex to grow CAR-T cells. Cytiva manufactures the Sepax C-Pro, which is used for T-cell isolation. “
Dropulic added that reducing prices is a primary goal, explaining that the organization has developed a procedure that makes CAR-T production cheaper.
“Our cellular procedure is more agile and physically powerful than other methods. This aims to reduce the production load of CAR-T cells.
“We used Sepax C Pro to isolate T cells, an antibody cocktail we developed called TPure. The purified T cells are then cultured in GRex bioreactors for seven days, after which Sepax C Pro is used to wash and formulate the cells for infusion.
Caring Cross has also kept things going from a bioprocess generation perspective, according to Dropulic.
“Our procedure doesn’t use automation right now because a lot of those automated devices use bioreactors and reagents that are very expensive and increase COGS. Therefore, our approach is to simplify the use of readily available devices and materials. We intend to introduce AI into our procedures, although we are only at an early stage.
Caring Cross and Fiocruz will continue to create mobile treatments for leukemia and lymphoma. However, the goal is to eventually produce a mobile treatment for HIV that is recently being tested in clinical trials in the United States.
The new production operation will be in Rio de Janeiro, in a facility operated through Fiocruz’s immunobiological unit, Bio-Manguinhos. The site will also manufacture the lentiviral vectors needed for the production of CAR-T therapies.
Caring Cross added that in addition to the construction capacity in Brazil, the partnership will supply the critical apparatus and education needed to manufacture CAR-T cells for other organizations in Latin America.