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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...

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...

勃林格殷格翰与Sutro Biopharma宣布利用Sutro的电芯无细胞表达科技成功大规模生产Luvelta,用于卵巢癌治疗;实现行业板块里程碑,生产4,500升符合临床研究的GMP批次...
Benzinga ·  01/07 22:01

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

勃林格殷格翰与Sutro Biopharma宣布成功大规模生产用于卵巢癌治疗的Luvelta,采用Sutro的电芯无细胞表达科技;在达到临床研究质量标准的4,500L GMP批次中实现了行业里程碑

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.

勃林格殷格翰BioXcellence和Sutro Biopharma Inc.今天宣布,他们成功地将Sutro自主的电芯无细胞表达科技应用于商业规模,制造了luveltamab tazevibulin (luvelta),这是Sutro的针对FRα的抗体药物结合物(ADC),旨在治疗广泛的卵巢癌患者及其他FRα表达的癌症。

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.

这是跨职能团队首次将Sutro的无细胞蛋白合成平台从小规模优良制造实践(GMP)生产扩展到大规模GMP生产,标志着行业里程碑。所有在奥地利维也纳勃林格的大规模制造设施中生产的4,500 L的luvelta批次均符合临床研究所需的产品质量标准。

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.

Sutro的无细胞平台利用了生成蛋白所需的细胞成分。无细胞提取物包含合成所需的一切,包括能源生产、转录和翻译。通过添加特定的DNA序列,可以合成所需的蛋白。这项科技已被证明对从小肽到复杂的哺乳动物蛋白(如单克隆抗体)等大范围分子规模都有效。

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