Monoclonal antibody (mAb) therapeutics are manufactured using a templated approach that requires robust, scalable solutions for all steps from cell line development to final fill. Increased process understanding has led to advancements in mAb manufacturing that include efficiencies in both upstream and downstream processing. Upstream, these advancements have resulted in higher mAb titers, while downstream purification operations are evolving to process high-concentration intermediates more efficiently, from purification to formulation.
Because of their value for persistent or terminal conditions, mAb manufacturers are continually striving to meet increasing global demand while controlling costs and maintaining manufacturing flexibility for their expanding clinical pipelines.
Biopharmaceutical Application Guide
Viral Safety in Bioprocessing
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 filling of drug products must meet stringent requirements for sterility, integrity, cleanliness, operational safety, and efficiency
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
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
Protein aggregates are a concern throughout upstream and downstream mAb manufacturing, and control is key to maximizing process efficiency and robustness
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