
For the first time, the cross-functional teams were able to scale up Sutro’s cell-free protein synthesis platform from a small-scale Good Manufacturing Practice (GMP) production to a large-scale GMP production marking an industry milestone. All batches of luvelta manufactured in 4,500 L at Boehringer’s large-scale manufacturing facility in Vienna, Austria, met the product quality criteria required for the use in clinical studies.
Sutro’s cell free platform utilizes cellular components necessary for protein generation. The cell-free extract contains everything that is needed for synthesis, including energy production, transcription, and translation. By adding a specific DNA sequence, the desired protein can be synthesized. This technology has proven effective for a large range of molecule sizes, from small peptides to complex mammalian proteins such as monoclonal antibodies.
“We’re thrilled that our long-standing partnership with Sutro built the foundation to choose our site to demonstrate its technology on a commercial scale, which proves our reputation as manufacturing experts," said Dr. Tilman Rock, site head Biopharma Austria at Boehringer Ingelheim. Ute Lehmann, Head of Business Development, Key Account Management & Marketing of Boehringer Ingelheim’s contract manufacturing arm, BioXcellence, added: "Our partnership with Sutro shows how we can achieve more together. It's through these synergies that we enhance our capabilities, complementing our partners' expertise. This is the essence of our partnership approach at Boehringer Ingelheim BioXcellence™.”
A unique advantage of the Sutro cell-free protein synthesis platform is its modular approach. It uses non-natural amino acids to achieve site-specific conjugation of proteins to chemicals in a way that isn’t possible with cell-bound approaches. This is a crucial aspect in creating, for instance, next-generation ADCs for oncology treatments that are designed to have certain benefits in the safety and efficacy profile compared to ADCs produced by traditional methods. Sutro's lead candidate was selected to demonstrate commercial viability. These insights can be applied to their robust pipeline of next-generation ADCs targeting a variety of cancers.
"In our partnership with Boehringer Ingelheim BioXcellence™, 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,” said Venkatesh Srinivasan, PhD, Sutro’s Chief Technical Operations Officer. “Today we are excited to share that we have achieved this goal together with our partner. We look forward to applying these learnings to our broader ADC pipeline. Sutro is actively seeking business development partners to continue to advance and accelerate our technology platform’s potential and our product pipeline.”
Bron: www.ir.sutrobio.com