Introduction of Shengming Bio
Shengming Bio is wholly owned subsidiary of Hualan Group and can provide CRO and CMO services related to monoclonal antibody drugs that fully meet the requirements of CFDA/FDA.
The contents of services include screening mono antibody, evaluation, process R&D, drug analysis, preparation development, approval production, filling and packaging, labeling, etc.
CMO(Contract Manufacture Organization) Business: With the world-class pilot plant and manufacturing base in conformity with US and European standard, We could contract manufacture(CMO) products, filling and lyophilization for clinical application and large-scale production.
1. Laboratory Scale Platform
Hualan Bio owns dozens of different types of bioreactors and several AKTA from GE company. We can undertake screening antibody, development and optimization of 3-15L various culture and purification process.
2. Pilot Scale Platform
● 3 production lines of 200L cell culture, including 2 stainless steel production lines and 1 line of disposable reactor;
● 2 downstream purification lines. Chromatographic column and chromatographic system are both from American GE company;
● 1 automatic filling line for the production of lyophilized powder and liquid preparations.
3. Large-scale Manufacture Platform
• The centralized PIVA
• Cell culture and Purification
• Choose production scale of 500L-2500L as need. Minimize culture intervals;
• Carry out continuous perfusion culture in the scale of 500L for 60 days by using ATF; meet production needs in multiple aspects.
• Programmed self-control is adopted in the operations of all processes, and the whole process is monitored online.
4. Contract Inspection: We can provide biological activity determination, purity and content testing, discriminant analysis, physical and chemical properties detection, molecular biology, package material compatibility test, and many other quality tests.
Shengming Bio. invites all enterprises on biologics R&D、manufacturing and marketing at home and abroad for sincere cooperation and common development, For any detailed information, please consult
TAG:  Shengming Bio, Hualan Bio, monoclonal antibody drug, Subsidiary