Boehringer Ingelheim BioXcellence and Sutro Biopharma Inc. have announced the successful application of Sutro’s proprietary cell-free expression technology on a commercial scale to manufacture luveltamab tazevibulin (luvelta). This marks the first time Sutro’s cell-free protein synthesis platform has scaled from small-scale Good Manufacturing Practice (GMP) production to large-scale GMP production. 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 use in clinical studies.
Product Profile and Technology
Luvelta is 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. The partial synthesis process of STRO-002’s FR alpha-targeted antibody is realized by the industry-leading cell-free protein synthesis technology (XpressCF), which can embed non-natural amino acids (XpressCF+) at specific protein sites. The non-natural amino acid side chains of the obtained antibody can be introduced into the cleavable linker small molecule load through a click chemistry reaction site, achieving ADC site-specific coupling.
Advantages and Applications
The DAR value (drug antibody ratio) of STRO-002 is 4, indicating high product uniformity, which is expected to solve the problems of pharmaceutical quality and pharmacology caused by traditional ADC non-site coupling. Additionally, the small molecule load of STRO-002 is a derivative of the marine extract Hamitrin, a novel microtubule inhibitor and weak substrate for P-glycoprotein pumps, with the potential to address drug resistance.
Significance of the Achievement
This milestone underscores the effectiveness of Sutro’s cell-free protein synthesis technology in scaling up production while maintaining high product quality. The collaboration with Boehringer Ingelheim highlights the potential of this technology to revolutionize the manufacturing process for complex biologics, ensuring more efficient and consistent production for clinical and commercial needs.-Fineline Info & Tech
