Merck

Monoclonal Antibody Manufacturing

Three individuals in lab coats are in a well-equipped laboratory setting. The person in the center is engaged in a conversation with the individual on the left. The person on the right is observing.

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. Closed single-use technologies have helped reduce manufacturing footprints, increase flexibility, decrease costs, and enhance quality.  

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.  


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Monoclonal Antibody Manufacturing Workflow

Purple circular diagram illustrating cell division and growth. The interconnected oval and irregular cell shapes within the circular structure suggest dynamic biological processes.

Upstream

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.

Illustration depiction of equipment used in mAb (monoclonal antibody) downstream processing.

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.

Illustration depicting final filtration and filling system.

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

Illustration of a viral safety filter used in biopharmaceutical processes. The filter has an elongated rectangular shape with rounded corners, two connectors on the top, and grid lines indicating the filtering membrane or material inside it.

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

Illustration of a rectangular filter with rounded corners and edges. The filter is enclosed within an outer structure that has circular elements at each corner.

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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