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Monoclonal Antibody Manufacturing

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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 

Related Applications
Cell Line Development
Developing highly productive clonal cell lines for production of therapeutic drugs is time-consuming, labor-intensive, and costly. Selecting the right cell line, however, can accelerate development of quality, regulatory-compliant material for pre-clinical trials and beyond.
mAb Downstream Processing
Optimization of the downstream steps in mAb processing is critical to ensuring product quality, yield, and sterility. Learn how to leverage various products, services, and solutions to get the most out of every step.
Final Sterile Filtration
Sterile filtration of drug products is a critical step to ensure product sterility and safety. Selecting a single-use final sterile filtration and fill-finish system can improve efficiency and maximize flexibility, meeting key production demands in today’s pharmaceutical industry.
Preventing Adventitious Agent Contamination in Your mAb Process
Adventitious viruses can contaminate bioreactors and interrupt biotherapeutic manufacturing. High-profile contamination events have led manufacturers to re-examine viral safety risk assessments. As a result, many manufacturers are implementing additional measures upstream of the bioreactor to prevent contamination.
Bioburden and Aseptic Control Strategy
Bioburden control in pharma or biopharma processes is critical to assuring the microbial safety of the drug for patients. Bioburden reduction or sterilizing filters are integral to all bioburden control strategies. Environmental monitoring, sterility testing, and bioburden testing confirm process control.
Detecting and Removing Aggregates
Protein aggregates are a concern throughout both upstream and downstream mAb manufacturing. Learn how to minimize aggregate formation to maximize process efficiency and robustness.
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