TAS::75 0893::TAS RAPID LARGE SCALE PRODUCTION OF PROTEIN THERAPEUTICS

a：为了有效地制造蛋白质治疗药物，承包商开发了一种哺乳动物表达载体pATG，该载体结合了人类DNA调控元件，以提供长期细胞系稳定性，确保最严格的高生产者选择，并使用最强的信号序列进行高水平分泌表达，而无需基因扩增。该系统将哺乳动物细胞系的发育从1年缩短到4-5周。

AWith a long-term objective to efficiently manufacture protein therapeutics, the Contractor developed a mammalian expression vector pATG that incorporates human DNA regulatory elements to render long-term cell line stability, ensures the most stringent selection of high producers, and uses the strongest signal sequence for high level secretory expression without gene amplification. This system shortens mamallina cell line development from 1 year to 4-5 weeks. To make this system user-friendly, in this Phase I study, the Contractor will devise novel ways to further reduce cell line development time to 2 weeks; and demonstrate the robustness of its new system by comparing with commercially available vectors in manufacturing model proteins. The Contractor will provide contract CMO services for generating stable, high-producing CHO cells lines for large-scale production of recombinant antibodies and vaccines.