Merck
CN

单克隆抗体生产

单克隆抗体生产需要强大的可扩展解决方案加速上市并帮助控制成本

单克隆抗体(mAb)治疗药物生产采用模板方法,从细胞系开发到制成品灌装的所有步骤都需要强大的可扩展解决方案。增进工艺理解推动了单抗生产进步,实现了上游和下游工艺效率提升上游的这些进展带来更高的单抗滴度,随着下游的纯化操作日益发展,可更高效地处理从纯化到制剂的高浓度中间产物。

单抗生产商秉承持之以恒或永续的价值观,始终如一地奋进满足日益提高的全球要求,同时控制成本并为扩大的临床管线维持灵活生产。



单克隆抗体生产流程

Cell Line Development

上游

The upstream process begins with cell line development and includes all steps up to cell harvest, with the goal of increasing cell densities and product titers to maximize mAb production.

Downstream

From cell harvest through final filling into vials, the comprehensive focus of downstream bioprocessing is on purification while controlling bioburden and assuring viral safety, in order to provide confidence in drug safety for patients.

Final Filtration and Filling

Final filling of drug products must meet stringent requirements for sterility, integrity, cleanliness, operational safety, and efficiency 

Viral Safety Assurance

Based on the principles of “prevent, detect, and remove,” viral safety combines risk analysis with careful selection of raw materials, extensive testing of raw materials and process intermediates, and implementation of virus reduction steps in downstream processing

Bioburden control

All mAb production processes are at risk for microbial contamination, requiring a process design with control strategies to mitigate the risk, as well as bioburden monitoring to assure process control

Aggregate Removal

Protein aggregates are a concern throughout upstream and downstream mAb manufacturing, and control is key to maximizing process efficiency and robustness