Nguyen Bach-Ngan, Tieves Florian, Rohr Thomas, Wobst Hilke, Schöpf Felix S, Solano Jóse D Montoya, Schneider Julia, Stock Janpeter, Uhde Andreas, Kalthoff Thomas, Jaeger Karl Erich, Schmitt Lutz, Schwarz Christian
NUMAFERM GmbH, Merowingerplatz 1a, 40225, Düsseldorf, Germany.
Institute of Biochemistry, Heinrich-Heine University, 40225, Düsseldorf, Germany.
AMB Express. 2021 Mar 25;11(1):48. doi: 10.1186/s13568-021-01204-w.
The production of peptides as active pharmaceutical ingredients (APIs) by recombinant technologies is of emerging interest. A reliable production platform, however, is still missing due the inherent characteristics of peptides such as proteolytic sensitivity, aggregation and cytotoxicity. We have developed a new technology named Numaswitch solving present limitations. Numaswitch was successfully employed for the production of diverse peptides and small proteins varying in length, physicochemical and functional characteristics, including Teriparatide, Linaclotide, human β-amyloid and Serum amyloid A3. Additionally, the potential of Numaswitch for a cost-efficient commercial production is demonstrated yielding > 2 g Teriparatide per liter fermentation broth in a quality meeting API standard.
通过重组技术生产作为活性药物成分（API）的肽正引起越来越多的关注。然而，由于肽的固有特性，如蛋白水解敏感性、聚集性和细胞毒性，可靠的生产平台仍然缺失。我们开发了一种名为Numaswitch的新技术来解决当前的局限性。Numaswitch已成功用于生产各种长度、物理化学和功能特性各异的肽和小蛋白，包括特立帕肽、利那洛肽、人β-淀粉样蛋白和血清淀粉样蛋白A3。此外，还证明了Numaswitch具有成本效益高的商业生产潜力，在达到API标准质量的情况下，每升发酵液可产生超过2克特立帕肽。
