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

为了实现高效生产蛋白质治疗剂的长期目标，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，以提供长期的细胞系稳定性，确保最严格地选择高生产者，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。该系统将乳腺癌细胞系的开发从1年缩短到4-5周。 为了使该系统易于使用，在第一阶段研究中，承包商将设计新的方法，进一步将细胞系开发时间缩短至2周;并通过与商业上可用的载体在制造模型蛋白质方面进行比较，证明其新系统的稳健性。承包商将提供合同CMO服务，用于生产稳定、高产的CHO细胞系，用于大规模生产重组抗体和疫苗。

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.