Sirona Biochem Corp. Contracts WuXi AppTec for Large-Scale Manufacturing of TFC-1067
September 09, 2020 at 03:00 am
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Sirona Biochem Corp. ('Sirona') announced that it has signed an agreement with Contract Manufacturing Organization (CMO) WuXi AppTec ('WuXi'), Shanghai, to launch large-scale production of TFC-1067, a novel skin dark spot remover, for global commercialization. WuXi has spent four months developing their manufacturing process for commercial grade TFC-1067. This process was recently completed, resulting in a highly pure production of TFC-1067 with the ability to scale to any quantity needed by Sirona. Sirona anticipates the need for multi-kilogram production of TFC-1067 through the remainder of 2020 with sustained large-scale quantities for commercialization required in 2021. To prevent gaps in manufacturing, and minimize risk, the compound will be produced in multiple locations. Roowin, the current CMO in France, will remain a producer in addition WuXi. Given the high potency of TFC-1067, each kilogram of Sirona's active ingredient will produce up to ten thousand consumer size (fifty milliliters) containers of finished product.
WuXi AppTec Co., Ltd. specializes in providing a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical and biotech industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. Net sales break down by activity as follows:
- laboratory services (60.9%): small molecules discovery services, bioanalytical services, medical devices safety testing services, comprehensive manufacturing and testing services for cell and gene therapies, etc.;
- CMO and CDMO services (31.9%): development of manufacturing processes, production of advanced intermediates and active pharmaceutical ingredients, formulation development and dosage drug product manufacturing, for preclinical and clinical trials, new drug application, and commercial supply of chemical drugs, etc.;
- clinical research services (7.1%): project planning, clinical operation and monitoring and managements of phase I-IV clinical trials, medical device trials, etc.;
- other (0.1%).
Net sales are distributed geographically as follows: China (25.1%), Asia (4.1%), the United States (53.6%), Europe (16%) and other (1.2%) .