mAbs Development & Manufacturing

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.

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Therapuetic Antibody Discovery

Large molecule drug discovery begins with identifying the functional therapeutic target and evaluating its role...

Target Discovery

Identify novel therapeutic targets using the most comprehensive set of genome-wide functional screening tools available...

Lead Discovery

Antibody lead discovery involves a multi-step process to generate and select lead molecules that bind to your target…

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Problem Statement

Uncover, select, and validate new targets with a strong link to disease...

Problem Statement

Discover the solution that is described here in a short teaser text.

Problem Statement

Uncover, select, and validate new targets with a strong link to disease...

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Related Categories

Bioprocessing Cell LInes

Bio4C ProcessPad™ software is a data collection, visualization, and analytics

Bioprocessing Single-Use Bioreactors

Bio4C ProcessPad™ software is a data collection, visualization, and analytics

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Recognized at the Outsourced Pharma and Life Science Leader 2023 CDMO Leadership Awards in 5 Categories

Related Resources

Comparison of Process-related Impurity Clearance for Membrane Adsorbers and Resin-based Chromatography Technologies
The performance of membrane adsorbers for antibody purification is compared to quaternary amine resins, membranes, and salt-tolerant primary amine membranes.
Improved Process Understanding and Product Quality through Continued Process Verification
Continued process verification is critical to maintain the strength, quality, and purity of the final drug product. It is a regulatory expectation as manufacturers are instructed to ensure their process remains in a continual state of control. Learn more in this technical article.
Accelerated mAb Development Program – From Transfection to GMP Drug Substance in 9 Months
The accelerated mAb development program delivers GMP drug substance nine months from transfection. We designed the mAbExpress™ program to be fast, cost effective, and appropriate for the early clinical phase of your program, with regulatory support throughout.
Comparison of Process-related Impurity Clearance for Membrane Adsorbers and Resin-based Chromatography Technologies
The performance of membrane adsorbers for antibody purification is compared to quaternary amine resins, membranes, and salt-tolerant primary amine membranes.
Viral Safety in Bioprocessing
Viral safety in bioprocessing relies on a framework of (1) preventing contamination, (2) detecting contamination, and (3) removing or inactivating viral contaminants.
Preparing CHO Cells for Higher Productivity by Optimizing a Perfused Seed Train
This application note describes the benefits and performance of Cellvento^® 4CHO-X Expansion Medium designed for multiple cell expansion steps from vial thaw to N-1 stages to generate higher biomass for inoculating fed-batch production bioreactors