Cell Line Development


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.


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