Sutro Biopharma, Boehringer Ingelheim achieve large-scale cell-free biomanufacturing

Sutro Biopharma and Boehringer Ingelheim BioXcellence have successfully scaled Sutro’s proprietary cell-free expression technology to a commercial level, producing luveltamab tazevibulin (luvelta), an antibody-drug conjugate (ADC) targeting ovarian and other cancers.

Manufactured in 4,500-liter batches at Boehringer Ingelheim’s facility in Vienna, Austria, the production met GMP standards required for clinical use.

This marks the first large-scale application of Sutro’s cell-free protein synthesis platform, which enables precise protein generation without live cells, according to the South San Francisco clinical-stage company. The platform uses non-natural amino acids for site-specific conjugation, supporting the development of advanced ADCs with potential safety and efficacy benefits.

“We have been working toward demonstrating that ADCs built with our cell-free platform can be manufactured by a third party at commercial scale under GMP conditions,” Venkatesh Srinivasan, chief technical operations officer at Sutro, said in a statement. “Today we are excited to share that we have achieved this goal together with our partner.”

Srinivasan said that the company will apply the lessons learned in working with Boehringer Ingelheim to Sutro’s broader ADC pipeline. Sutro is actively seeking business development partners to continue to advance and accelerate our technology platform’s potential,” he added.

Sutro’s luvelta, a folate receptor-α-targeting ADC, is in Phase 3 development for ovarian cancer and earlier stages for other tumors. The company is also working on next-generation ADCs designed to mitigate toxicity risk and improve efficacy. Its early-stage pipeline includes dual-payload and immunostimulatory ADCs.