Patients in Brazil will soon have increased access to CAR-T therapies after U.S. non-profit Caring Cross partners with government-backed biomedical research institution Fundação Oswaldo Cruz (Fiocruz) to establish manufacturing capacity.
Maryland-based Caring Cross announced the collaboration in March, explaining the aim is to help develop production capacity for chimeric antigen receptor (CAR)-T cell and stem cell gene therapies in Brazil.
Under the deal, Caring Cross will provide Fiocruz with the technology, materials, and training needed to manufacture CAR-T cell therapies, including the know-how to produce its proprietary lentiviral vectors.
As executive director Boro Dropulic, PhD, told GEN: “Caring Cross will provide the methods to manufacture CAR-T cells and the vectors needed for T cell reprogramming.”
“The bioreactors are purchased from companies that manufacture them. For example, Scale Ready manufactures the GRex needed to culture the CAR-T cells. Cytiva manufactures the Sepax C-Pro that is used for isolation of T cells.”
Dropulic added that cost reduction is a major aim, explaining the organization has developed a process that makes it cheaper to produce CAR-T products.
“Our cell process is more simplified and robust than other methods. This is important to reduce the cost to manufacture CAR-T cells.
“We utilize the Sepax C Pro to isolate the T cells using an antibody cocktail we have developed called TPure. The purified T cells are then cultured in GRex Bioreactors for seven days, after which the Sepax C Pro is used to wash and formulate the cells for infusion.”
Kept things simple
Caring Cross has also kept things simple from a bioprocessing technology perspective, according to Dropulic.
“Our process does not use automation at the present time since many of those automated devices use bioreactors and reagents that are very expensive and drive up the COGS. So our approach is to simplify using devices and materials that are readily available. We intend to implement AI into our processes, but that is currently at an early stage.”
Caring Cross and Fiocruz will focus on making cell therapies for leukemia and lymphoma. However, in time the plan is to produce an HIV cell therapy that is currently being tested in clinical trials in the United States.
The new manufacturing operation will be in Rio de Janeiro at a facility operated by Fiocruz’s immunobiologics unit, Bio-Manguinhos. The site will also make the lentiviral vectors needed to produce the CAR-T therapies.
Caring Cross added that, in addition to boosting capacity in Brazil, the partnership will provide access to critical materials and training needed to manufacture CAR-T cells for other organizations across Latin America.
