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Maximize the Potential of Your Monoclonal Antibody Production

Stable cell line and process development play vital roles in monoclonal antibody (mAb) production. It starts by selecting the appropriate cell line based on productivity, stability, and desired post-translational modifications. Once the cell line and clones are chosen, the process development phase begins. Screening various media and feed formulations followed with spend media analytics help ensure that the selected clones meet their specific nutritional requirements, facilitating optimal cell growth and efficient mAb production conditions. In downstream process development, different resins and buffer conditions can be screened to identify the most suitable conditions for capturing and purifying the desired mAb product.


Upstream process development

Upstream process development includes stable cell line development and identifying suitable nutritional conditions through media and feed screening. Benchtop process studies refine parameters like temperature and pH, ensuring the robustness of the selected clone for bioreactor processes. These activities collectively enable efficient and scalable production of high-quality mAb therapeutics.

 

Cell line development

Stable CHO cell line development is one of the key steps in developing a successful mAb production process. All Gibco Freedom cell line development products are cGMP compliant, with no need to source components or develop vectors, allowing you to focus on quickly moving your workflow from cell line to process development. The Freedom cell line development kits include components for transfection, expression, clone creation, and stable cell line selection—all in a conveniently packaged kit. The kits also offer high titers and simplified commercial licensing options.

Gibco Freedom ExpiCHO-S Kit

Easy transition from transient to stable clones—all in one CHO-S cell line. Dual vector system that provides ability to control heavy- to light-chain ratios. Can achieve titers of 3–5 g/L in fed batch cultures.                                                       

Gibco Freedom CHO-S Kit

Easy-to-use, beginning-to-end kit for cloning and recombinant protein expression in CHO-S cells. Can achieve IgG titers over 3 g/L. Complete workflow that can take your gene of interest from transfection to lead clone in as little as in 5 months.

Gibco Freedom DG44 Kit

Stable cell line development kit including Dihydrofolate reductase deficient (DHFR-) CHO cells. Complete workflow that can take your gene of interest from transfection to lead clone typically as little as six months.                                                                           

Media, feed, and supplement screening

It is critical to find the right media, feed, and supplement solution for CHO cell cultures. Our optimized off-the-shelf Gibco screening solutions help facilitate the identification of the optimal growing conditions for your cell line.

 

Gibco CHO Media     

Available in multiple formats designed to optimize your mAb production workflow, our extended portfolio includes our latest media and feed formulations to deliver superior product performance, improved product titer, better product quality and lot-to-lot consistency.                                                                        

Gibco Feeds and Supplements 

Select from a variety of feeds, peptones and supplements that are designed to enhance mAb expression in CHO cultures and improve protein quality to target a specific glycan profile. Gibco Starter Paks provide samples of our most widely used peptones tailored for specific applications including mAb production.

Gibco CHO Media and Feed Panels

Developed with diversity in mind, providing a panel of products that each have distinct formulation and nutrient levels, allowing you to quickly identify the components driving increased productivity and quality.                                                                                                                                               

Benchtop process development

We offer a comprehensive solution for scaling up from research to commercial-scale manufacturing, including modular hardware, sensors, and state-of-the-art bioreactors that enable strategic and streamlined bioprocess control. Our products are designed to support the entire scale-up process, providing an innovative control platform and flexible operating system.

Thermo Scientific HyPerforma Glass Bioreactors

Offering easy operation and rapid assembly with the highest standards of materials and surface finish available in 1, 3, 7, and 15 L.                                                                                               

Thermo Scientific TruBio Bioprocess Automation and Control Software

Simplify your data management and transfer by utilizing Thermo Scientific TruBio automation software from research to commercial manufacturing.

Thermo Scientific HyPerforma G3 Bioprocess Controller

Providing easy process scale-up or scale-down and the configurability to modify control strategies along with your process.                                                   


Downstream process development

Resin screening helps select the most suitable resin for capturing and separating the mAb from impurities. Buffer screening identifies optimal conditions for each purification step, maximizing mAb recovery and purity. These processes help enhance yields, reduce impurities, and improve process robustness

 

Capture chromatography

Our innovative portfolio of affinity chromatography resins help you solve downstream process challenges for next-generation antibody therapeutics. These resins are specifically designed for the purification of engineered monoclonal antibody (mAbs) modalities.

 

Pre-filled 96-well screening plates are designed for easy high-throughput screening, enabling multiple conditions to be evaluated in a single plate experiment. Pre-packed chromatography columns help simplify the resin selection for the downstream process.

GoPure MabCaptureC Screening Plate, 96-well

The MabCaptureC ligand is an engineered Protein A ligand resulting in high dynamic binding capacity and excellent alkaline stability. The in-house manufactured Protein A ligand is produced in yeast to ensure a non-animal derived production process.

CaptureSelect GoPure FcXP Screening Plate, 96-well

Specifically developed to bind antibody-subdomain regions for the purification of novel antibody therapeutics, such as bi-specific monoclonal antibodies, Fab fragments, and Fc-fusion proteins.                                                                

Pre-Packed Chromatography Columns

The GoPure and MiniChrom 1 mL and 5 mL columns are designed for bench-scale resin screening, process development, and sample preparation, and can be used for quick screenings of application feasibility and lab-scale purification.

Polish chromatography

After the mAb affinity chromatography, an AEX polish step is typically required, which can be followed by a CEX or HIC polish step depending on impurity profile and process challenges. The polish step in mAb downstream processing removes aggregates, charge variants, HCP, host cell DNA, and aids in viral clearance. Our Resin Selection Tool guides you through the suitable resin options for the downstream polish steps with some examples below

 

POROS GoPure XQ Pre-packed Column

Intended for screening of ion exchange resins such as POROS XQ, and for small scale mAb purification. Features a strong anion exchange functional group and is a high capacity and high-resolution resin with excellent salt tolerance.                                                                                                                           

POROS Benzyl Ultra Hydrophobic Interaction Chromatography (HIC) Resin

The aromatic hydrophobic ligand provides high selectivity, enabling the purification of diverse biomolecules such as antibody therapeutics, antibody fragments and antibody drug conjugates. High capacity allows for significant reduction in process volume for subsequent purification steps.      

POROS Caprylate RoboColumn

Operates in flow-through mode, which helps reduce costs, especially when working with more engineered monoclonal antibody derivatives. The unique selective capture of aggregates and high molecular weight impurities contributes to a high yield of the targeted monomer while using established cation exchange resin buffer systems.


Analytics and quality testing

Gibco Bioprocessing Analytical Services

Gain actionable insights powered by trusted technology and experience.  We offer a comprehensive suite of analytical services, ranging from spent media and protein analytics to metabolite and lipid analysis, to help you make informed decisions to improve performance. 

Mycoplasma detection

Mycoplasmas—the smallest known free-living organisms—are difficult-to-detect bacterial contaminants in mammalian cell cultures. In therapeutic applications, undetected mycoplasma contamination can negatively impact product quality and patient safety. 

 

The Applied Biosystems MycoSEQ Mycoplasma Detection System is an integrated, real-time PCR (qPCR) solution for rapid mycoplasma testing. Comprised of functionally confirmed sample-to-answer protocols, commercially available kits for sample preparation and qPCR, and instruments with analytical software to help enable regulatory compliance, the MycoSEQ Mycoplasma Detection System workflow provides a flexible approach to meet a variety of mycoplasma testing applications.

 

MycoSEQ Mycoplasma Detection Kit

MycoSEQ kits are an alternative to costly, time-consuming culture-based tests, delivering accurate and actionable results in about five hours. Backed by technical and regulatory experts and a successful track-record of regulatory acceptance, MycoSEQ Detection Kits can help simplify mycoplasma detection for both in-process and lot-release testing.


Additional resources

Enhance your bioprocessing knowledge with educational content to help you understand issues, solve problems, and make solid decisions.

Deep dive into a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing.

Learn, evaluate, connect.

 

 

 

 

 

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Thermo Fisher Bioprocessing Portfolio

Upstream bioprocessing

Develop and scale biomanufacturing processes efficiently with trusted technologies and full-service support.

 

Downstream bioprocessing

Streamline downstream biomanufacturing and improve product quality with innovative technologies and outsourcing services to drive efficiency.

Assurance of supply

We strive to support industry growth by investing in capacity and quality systems for a reliable supply of critical materials.