mAb Upstream Processing

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Advance upstream performance for reliable mAb production

Upstream (USP) work often slows when titers, clone stability, or early optimization steps fall short of expectations. Build a stronger start by combining stable cell line development, informed media and feed selection, and early benchtop bioreactor evaluation. Together, these activities help reduce variability, improve consistency, and create a more scalable foundation for monoclonal antibody (mAb) bioprocessing.

Workflow-based mAb upstream development strategies


Gain practical guidance on improving processes by exploring strategies for cell line selection, media and feed screening, and early bioreactor optimization in this webinar summary.
 

Streamline mAb upstream process development

Upstream development can slow when teams must balance cell line selection, nutrient optimization, and early bioreactor studies under tight timelines. Help unify these steps with connected upstream tools from Gibco Freedom cell line development kits and Chinese hamster ovary (CHO) screening panels to the Gibco Efficient-Pro Media and Feed System and scale-ready bioreactors. This integrated approach helps improve productivity, reduce variability, and support smooth transitions from screening to process optimization.

Strengthen cell line development, media, and feed screening

Facilitate early upstream progress by combining Freedom cell line development kits with media and feed screenings. Efficient-Pro and CHO panels are designed for rapid identification of nutrient drivers and support clone stability, allowing teams to make data-driven selections at greater speed.

Enhance culture performance with the Efficient-Pro system

Use the Efficient-Pro System to support reliable CHO culture performance. Its paired formulations help improve titer, maintain viability, and reduce variability during early upstream development.



 

Evaluate nutrient drivers with CHO media and feed panels

Enable focused, rapid testing to help pinpoint nutrient influences on culture performance with CHO media and feed panels. Support from Field Application Scientists (FAS) helps teams refine conditions and guide more confident optimization decisions.

 

Improve benchtop process development

Early benchtop studies often determine whether upstream gains can translate to larger volumes, yet teams may face gaps in control, monitoring, and scalability. Facilitate this bridge between optimization and scale-up by using benchtop bioreactors equipped with modular hardware, integrated sensors, and flexible control platforms. These systems support precise adjustment of parameters, such as pH, temperature, agitation, and gas transfer, enabling selected clones to perform reliably as processes advance toward pilot and manufacturing stages.

Support upstream process development with bioreactors

5 L Thermo Scientific DynaDrive Single-Use Bioreactors (S.U.B.s) and glass bioreactors allow scalable mixing, gas transfer, and control for consistent seed train development and smoother process transfer with compatible bioprocess containers (BPCs) and unified engineering.

Enhance upstream control with flexible bioprocess controllers

Enable precise parameter control and adaptable strategies for benchtop and pilot vessels with Thermo Scientific HyPerforma G3 Bioprocess Controllers, helping maintain consistency and scalability across upstream studies.

 

Connect process development with flexible automation platforms

Thermo Scientific TruBio Process Control Software supports control strategies across development systems, enabling consistent recipe execution, streamlined data capture, and real-time process visibility. This can enable faster scale-up, improved compliance, and reduced risk.

Maintain quality and process insights across USP workflows

Upstream variability can introduce impurities or contamination risks that affect mAb downstream (DSP) efficiency and overall batch success. Apply analytical and impurity testing solutions to monitor culture health, verify purity, and support regulatory-aligned process verification. Mycoplasma detection solutions, including Applied Biosystems MycoSEQ platforms, offer rapid, sensitive screening to help teams identify issues early and maintain consistent product quality throughout development.

Strengthen contamination control and mycoplasma detection

Accelerate contamination control using MycoSEQ and SEQ PCR-based assays for rapid mycoplasma detection. These sensitive methods allow same-day results, enabling early action to help reduce batch risk.

Support upstream decision-making with analytical tools

Use analytical HPLC columns for accurate and reproducible mAb titer measurement during development, enabling teams to reliably compare clone performance, efficiently track productivity, and confidently select high-producing candidates.

Explore media development services to enhance USP


Advance upstream performance by tailoring media formulations to your specific clone and process, resulting in maximized yields, reduced variability, and greater reproducibility. Gibco Media by Design Services allows teams to refine nutrient balance, increase titers, and strengthen culture consistency through collaborative development.

Explore the 3D mAb workflow

Frequently asked questions

Select a productive clone using CHO Freedom cell line development kits designed to produce stable mAb-producing clones. Work with FAS for clone selection and effective cell culture media and feed screening. This combined approach was developed to identify top clones, address variability, and accelerate early upstream development.

Maximizing titers begins with balancing nutrient supply throughout the culture process. The Efficient-Pro System offers matched formulations that support consistent performance across CHO cell lines. Media and feed panel screenings further help identify optimal combinations through data-driven comparisons. Using these insights, teams can refine culture conditions to improve productivity and reduce run-to-run variability in mAb production.

Offline analytics help reduce upstream risk by enabling early detection and consistent monitoring. PCR-based contamination assays, such as mycoplasma testing, offer rapid identification of contamination that could compromise clone stability. Pairing these methods with routine titer measurements supports selection and banking of high-producing, mycoplasma-free clones. Together, these strategies offer timely insights that can strengthen decision-making during upstream development.

Designing an effective seed train is important for translating early gains to larger volumes. Evaluate clone behavior across small-scale bioreactors and consider N-1 strategies to support consistent growth. Solutions, such as the DynaDrive System, flexible bioprocessing controllers, and automation platforms, help teams standardize mixing, gas transfer, and control parameters, allowing for more predictable scale-up and smoother transition to pilot and manufacturing stages.

Upstream decisions directly influence downstream capacity and efficiency. Higher titers and cell densities can increase impurity loads, influencing downstream strategies that can adapt to increasing mAb quantities and impurities. Screening high-capacity affinity chromatography resins, evaluating buffer strategies, and incorporating flow-through polishing help maintain productivity and robustness as processes scale.

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.