Boehringer Ingelheim And Sutro Biopharma Announced Successful Large-Scale Production Of Luvelta Using Sutro's Cell-Free Expression Technology For Ovarian Cancer Treatment; Achieved Industry Milestone With 4,500L GMP Batches Meeting Clinical Study Quality Standards
Boehringer Ingelheim BioXcellence and Sutro Biopharma Inc.today announced that they successfully applied Sutro's proprietary cell-free expression technology on a commercial scale to manufacture luveltamab tazevibulin (luvelta), Sutro's Tubulin FRα-targeting antibody-drug conjugate (ADC) designed to treat a broad range of patients with ovarian cancer and other FRα expressing cancers.
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.
