Comprehensive Quality and Validation System, CN/US/EU cGMP, QMS/SAP/LIMS
Beijing Mabridge Biopharmaceutical Co., Ltd. (the company) has rich experience in process research and development. The company has been applying the concept of “quality by design” (QbD) to every process development process. Our rich and stable technology platform has completed a number of domestic and international filing from DNA sequence to IND, and commercial license BLA projects.
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Analytical Science has a comprehensive platform for physical and chemical analysis, product characterization and biological activity analysis, covering the entire life cycle of biologics. Physical and chemical analysis is equipped with multi-brand analytical/Semi-preparative U/HPLC (with UV/PDA/FLD/ELSD detector and fraction collector), PA800 plus and ICE3 capillary electrophoresis apparatus. Product characterization has HPLC-MS/MS, Biacore, 2D-DIGE, HPLC-MALS, chemiluminescence imager, etc. Biological Analysis, with 30+ antigens and anti-drug Abs for popular drug targets and 40+ tumor cells, could carry out the primary and the Fc effector functions such as direct binding, competition binding, cell inhibition and direct killing activities and C1q, ADCC, CDC & FcRn.
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The company currently has three MFG Facilities in use or under construction, which can meet the full-process entrusted DS and DP MFG.
1st MFG Facility in Beijing is equipped with 2*200L Cytiva disposable reactors and 2*1000L Applikon stainless steel reactors; Bosch filling line, which is suitable for 2R, 6R, 10R vials, and the production rate can reach 15,000 vials per hour.
The 2nd MFG Facility in Beijing (under construction) is equipped with a 3*2000L Cytiva disposable reactor and a prefilled preparation filling line. And the 3rd MFG Facility in Hangzhou is under planning and construction.
With the help of SAP system and sound management system, the supply chain system could organize, execute, and control the business process more efficiently, which leads to the optimization of the entire supply chain and supply network and guarantees the realization of the planning throughout the entire supply chain. And this realization provides the company with an accurate, timely and stable supply for its production and operation requirements. Supply chain management involves all forms of business from order entry to product delivery to manufacturing business processes, including forecasting, supply chain planning, demanding, purchasing, warehousing and distribution management.
Systematic supply chain management can not only reduce costs and inventory, but also make decent use of resources to achieve the visualization, management informatization, overall benefit maximization and cost minimization of the supply chain.
Focused on CDMO business, the company has established a comprehensive quality system that complies with the requirements of FDA, EMA and NMPA. The system is based on ISO 9001, supplemented by ICH Q10, and detailed by GMP covering the entire life cycle of drug product, includes process development, technology transfer and commercial manufacturing.
For contract research and manufacturing, a system for client’s intellectual property protection has also been established.
The quality system is reviewed and maintained by the QA department on a regular or irregular basis to ensure continuing effectiveness.
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