Cellares and Cabaletta Bio, Inc. announced Cabaletta will evaluate Cellares? automated manufacturing platform, the Cell Shuttle?, through Cellares? Technology Adoption Partnership (TAP) program.

As part of the collaboration, the companies have agreed on a proof-of-concept technology transfer process for the manufacture of CABA-201, Cabaletta?s clinical-stage fully human CD19-CAR T cell product candidate, using the Cell Shuttle. Chimeric antigen receptor (CAR) T cell therapy is a personalized immunotherapy that involves collecting and genetically engineering a patient?s own T cells to bind and eliminate disease-causing cells. CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell investigational therapy with the potential to transiently, but completely, eliminate B cells throughout the body, potentially enabling an immune system reset in patients with autoimmune disease.

CABA-201 is currently under evaluation in Phase 1/2 clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis, and generalized myasthenia gravis. Cellares? TAP program offers cell therapy developers a swift and low-risk path to embrace the company?s automated manufacturing technology for their pipeline products.

Cabaletta is utilizing this program to assess the automated manufacturing process and generate data that validates the Cell Shuttle?s viability as a manufacturing option for CABA-201. Cellares partners with leading developers through its TAP program to integrate the Cell Shuttle as a GMP manufacturing solution for pre-clinical, clinical and commercial-stage cell therapies at their IDMO Smart Factories. Cellares?

innovative manufacturing technology transforms autologous and allogeneic cell therapy processes, covering nearly 90% of cell therapy modalities. Through its TAP program, Cellares can facilitate the automation and tech transfer of manual processes onto the Cell Shuttle manufacturing platform in just six months. This program allows cell therapy developers to seamlessly integrate their processes onto a Cell Shuttle at any stage of development ?

from pre-clinical to post-regulatory approval. With automation, standardization, and software-defined manufacturing (SDM), subsequent tech transfers become instant to any other Cell Shuttle in any IDMO Smart Factory worldwide.