CMO(Contract Manufacture Organization)
Three-in-one CMO customization service
According to the characteristics of new drug R&D and production steps, the company carries out strategic cooperation with customers to provide high-quality and efficient exclusive CMO services.
The plant has two state-of-art aseptic production lines for injection-form drugs, namely the lyophilized powder injection line and cartridge / pre-filled syringe line.
Production Lines for biologic drugs are equipped with facilities strictly complying with the updated cGMP requirements. The plant has a construction area of approximately 1,400 sqm. Of which, 600 sqm is aseptic area for production, equipped with 4 sets of HAVC systems, purified water system, water for injections, and steam and compressed air systems.
The production line for injection form lyophilized powder is comprised of lyophilized powder production machines from Truking Technology Limited and Tofflon Sci &Tech, which are equipped with washing, drying and filling capabilities, as well as a real-time remote particles and floating germs monitoring system from TSI USA. The production line is able to produce 20 million units annually.
Consisted of the nested lid and liner removal of DVE9070 and the nested multi-function filling and closing machine of SFM5110, the pre-filled sterile injection production line is manufactured by the German brand “Bausch+Ströbel”. The cartridge production line is able to produce 3000-8000 units /h. The pre-filled syringe production line is able to produce 11000 units /h.
The production line is highly-automated and stable. Production and transfer of biologics are completed under the Layer-A in a restricted-access barrier (RABS) system, which strictly inhibits manual intervention. Hence the biologics produced are aseptic and with reliable quality.
The dosing system provides precise measurement of up to three thousandths, the most precise of its kind in the world, thus ensuring the excellent quality of pharmaceutical product.
Mold replacement is simple and convenient, and the dosing amount may be adjusted according to various molds, which can meet various production requirements of nested cartridge or nested pre-filled syringe.
With the transfer of the pharmaceutical manufacturing industry chain and China's support for innovative drugs, the CMO industry will continue to grow rapidly.