mAb Bioprocessing Solutions

Support excellence throughout mAb development

Rising global demand for monoclonal antibodies (mAbs) places pressure on teams to achieve higher productivity, consistent quality, and scalable processes without increasing manufacturing costs. These challenges intensify as programs progress from the preclinical development and optimization phase through clinical scale-up and large-scale cGMP production. Thermo Fisher Scientific offers comprehensive solutions designed to optimize and intensify steps across therapeutic mAb production workflows. Our experienced specialists support informed decision-making to help strengthen performance and advance your program.

Explore our mAb manufacturing solutions

Intensified seed process solutions

High-density cell banking can help increase upstream efficiency by reducing seed train duration up to 50% and process area by up to 25% using the Thermo Scientific 50 L DynaDrive Single-Use Bioreactor* (S.U.B.). Help accelerate seed train readiness with Thermo Scientific TruBio Process Control Software.*

Enhance fed-batch performance

Integration of high IgG-producing CHO-K1 GS cell line with Gibco Efficient-Pro Medium and Feed System using a 500 L DynaDrive in a fed-batch process has demonstrated >160% increase in titer compared to the standard fed-batch and can lead to over 50% reduction in the cost per gram of mAb.*

Learn about the DynaSpin System

The Thermo Scientific DynaSpin Single-Use Centrifugation System can help reduce equipment footprint by up to 76% and depth filter usage by up to 37% in the clarification step, while reducing water consumption by up to 72%.*
 

Accelerate capture chromatography performance

Strengthen mAb purification with MabCaptureC Affinity Resin, designed to reduce resin cost per campaign by up to 34% together with the Thermo Scientific DynaChrom Single-Use Chromatography System.*

Simplify polish chromatography

Using POROS Benzyl Ultra Hydrophobic Interaction Chromatography (HIC) Resin in flow-through mode can streamline the polish step and help reduce the resin cost per batch by up to 37%.*
 

Optimize in-line dilution and buffer management

Utilizing the in-line dilution capabilities in the DynaChrom Single-Use Chromatography System using buffer concentrates can help reduce the footprint required for process liquid preparation by over 40%.*
 

*The data shown here represents illustrative examples derived from standard mAb and intensified mAb processes. Both sets of data show how Thermo Fisher Scientific’s BPG technologies, when modeled using BioSolve Process™ software, can help demonstrate the value of process intensification in both upstream and downstream workflows.
These examples highlight how combining high-performance media, optimized feed strategies, and intensified bioreactor processes can significantly increase productivity—potentially doubling typical mAb yields from ~4 g/L to ~8.4 g/L—while also helping to reduce time, labor, and consumable costs. Results are based on actual evidence generation from runs up to 500 L in scale and modeled case studies and are not guaranteed outcomes. Actual process performance will depend on site-specific factors such as configuration, scale, and process optimization.
Thermo Fisher Scientific provides this information to help illustrate the potential value of integrated intensification strategies and supports customers in achieving efficient, sustainable bioprocessing outcomes.

Advancing mAb preclinical process development to scale-up

Moving a mAb program from early development to commercial readiness requires coordinated improvements across upstream, downstream, optimization, and scale-up activities. Thermo Fisher supports various phases of development with solutions designed for the preclinical stage, benchtop downstream processing, process intensification up to 50 L, and scalable workflows suited for clinical (500 L) and commercial (500–5,000 L) manufacturing.

mAb upstream processing

Empower upstream processing by focusing on clone selection, media and feed screening, and early process optimization to build a robust and scalable foundation for monoclonal antibody manufacturing. This stage often requires high-titer cell culture systems, flexible bioreactors, and specialist support to help navigate clone variability and development timelines. Thermo Fisher offers solutions that can streamline preclinical upstream development and help prepare processes for scale, from media panels and cell line development tools to scalable bioreactor platforms.

mAb downstream processing


Support downstream development with solutions designed to rapidly screen resins, define bind-and-elute conditions, and evaluate polishing strategies at the benchtop scale. Early DSP work often requires high-throughput screening (HTS) formats, flexible buffer systems, and guidance for interpreting purification data to meet evolving impurity-reduction requirements. Chromatography resins, pre-packed formats, and process liquid solutions help streamline preclinical purification and prepare workflows for later optimization.

 

mAb process optimization and intensification

Promote process performance by refining upstream and downstream parameters once baseline productivity is established. Teams often evaluate specialized feed strategies to influence glycan profiles, compare fed-batch and intensified modes, such as perfusion, and assess DSP conditions to improve recovery and reduce impurities. Support preclinical optimization from benchtop through 50 L with media optimization services, bioprocess analytics, Field Application Scientist (FAS) guidance, and rapid prototyping tools that help strengthen process robustness and inform scale-up decisions.

mAb process scale-up


Prepare for clinical and commercial production by adapting upstream and downstream operations to larger volumes while maintaining process consistency, quality, and supply reliability. As programs scale to 500 L and beyond, teams often face increased facility footprint needs, higher buffer and media volumes, and heightened regulatory expectations. Thermo Fisher offers bioreactors, process liquid solutions, automation tools, and supply continuity that help streamline scale-up from 500 L clinical batches to 500–5,000 L commercial manufacturing.
 

Explore the 3D mAb workflow

Frequently asked questions

Monoclonal antibody bioprocessing refers to the production and purification of mAbs using biotechnological methods. It involves cultivating genetically modified cells that express recombinant antibodies, followed by downstream purification steps to isolate the final material. mAb bioprocessing is widely used to develop therapeutic antibodies to treat a range of medical conditions.

Developing and manufacturing mAbs presents challenges such as managing low or variable titers, maintaining product purity, and addressing footprint constraints as processes expand. Differences in cell culture conditions and purification efficiency can influence product efficacy and quality. Teams must also navigate the complexity of scaling to clinical or commercial volumes while meeting regulatory requirements, which can add operational and compliance pressures.

Solutions designed to improve mAb productivity and consistency during cell culture development include Gibco Freedom CHO cell line development kits, which can streamline the generation of high-producing clones. Optimized Gibco Efficient-Pro Media and Feed Systems support robust cell growth and antibody expression, while scalable DynaDrive bioreactors, ranging from 5 L to 5,000 L, facilitate consistent performance across development and manufacturing scales.

Process intensification can help reduce the cost per gram of mAbs by supporting higher production efficiency and improved resource use. Automation and high-density seed trains help increase upstream productivity, while intensified fed-batch or perfusion modes can strengthen yield. In downstream processing, high-capacity resins, flow-through strategies, and in-line dilution can reduce buffer volumes and labor, helping improve overall DSP economics.

Thermo Fisher offers comprehensive mAb workflow solutions that support each stage of development and manufacturing. These solutions can be strengthened by evidence-based economic modeling, showing how integrated technologies can improve productivity, minimize footprint and labor requirements, and help manage manufacturing costs while supporting sustainability goals. This combination of workflow breadth, technical guidance, and data-driven decision support helps teams advance programs more efficiently.

Supporting other therapeutic antibody development

Thermo Fisher also supports the development and manufacturing of additional therapeutic antibody modalities, including antibody–drug conjugates (ADCs) and bispecific antibodies (bsAbs). Explore these modalities within the broader bioprocessing applications framework.

Antibody-drug conjugates (ADCs)

Support ADC development with solutions built to streamline antibody production, conjugation-ready purification, and analytical workflows that help maintain product quality.

Bispecific antibodies (BsAbs)

Advance bsAb development with solutions that support complex molecule expression, purification strategies that manage chain pairing, and analytical tools that help evaluate product quality and consistency.

For research use or further manufacturing. Not for diagnostic use or direct administration into humans or animals.