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Intensify Your Monoclonal Antibody Process for Higher Yields and Faster Time-to-Market

Optimize and intensify process to help achieve higher yields and accelerate time-to-market for monoclonal antibody and antibody variant molecules. This involves refining cell culture performance and facilitating an easy process scale-up for production. Evaluate and optimize parameters such as cell culture media formulation, feed strategy, bioreactor operations, and process control. We can help you to implement process intensification techniques like perfusion to increase productivity and find scalable solutions in the downstream to reduce costs while maintaining high purification efficiency.

Upstream Process Development and Scale-up for CHO K1 Cells


Process liquids

Buffers for purification and viral inactivation, along with cell culture media, feeds, and supplements, are key contributors in achieving consistent process performance. Enabling the scalability and reproducibility of the process liquid preparation process is essential to maintaining consistent mAb production across different production scales.

Buffer, media, and feed preparation

Leverage our diverse portfolio of mixing and storage solutions for your mAb production process needs. We offer a broad range of bioprocess containers  (BPCs), including powdertainers and fluid transfer assemblies , to simplify your production processes. We also offer a wide range of ready-made buffersprocess chemicals and dry powders and media manufactured with advanced granulation technology (AGT) helping you to reduce process steps and increase lot-to-lot consistency.

Single-Use Mixers

Our two mixing platforms are designed for liquid/liquid and powder/liquid mixing of various process liquids using single-use technology and efficient bottom-driven impulse mixing or top-down driven mixing principles based on traditional stainless-steel mixing.                                      

Process Liquid Preparation Services

Let us help simplify your weigh-dispense-hydration (formulation) workflow for process liquid and buffer manufacturing by leveraging ready-to-hydrate (trusted-weight dry powders) and ready-to-use (pre-made liquids) chemicals.

Advanced Granulation Technology (AGT)

Leave the classical dry media concerns of complicated preparation, filtration difficulties, multistep processes, and lot inconsistency behind and start achieving more with the Gibco AGT media format.
 


Upstream process

Upstream process development and intensification strategies aim to streamline and enhance the upstream process, resulting in higher yields and improved cost-effectiveness of mAb production. The strategies include using high performing media and feed strategies and supplements, and implementing intensified and continuous bioreactor processes to maximize productivity.

Cell propagation: Media, feed, and supplements

Enhance your cell culture performance using our high-performing Gibco CHO Media. Our portfolio features Gibco Efficient-Pro Medium and Feeds, High-Intensity Perfusion (HIP) CHO Medium, and Gibco ExpiCHO Stable Production Medium (SPM), offering a variety of options for superior CHO cell culture. Additionally, we provide animal origin-free functional additives like FoamAway, FunctionMAX Titer Enhancer, and high-quality recombinant insulin to improve process performance and specific productivity.

Gibco CHO Media

Available in multiple formats designed to optimize your mAb production workflow, our extended portfolio includes our latest media and feed formulations designed to support 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.                                                                                                                                                    
 

High Intensity CHO Perfusion Medium

Gibco High-Intensity Perfusion (HIP) CHO Medium is a chemically defined, animal-origin free (AOF) medium that helps provides high titers in numerous CHO cells from beginning to the end of the process regardless of the type of perfusion platform, all while using less medium. Available in AGT format.

Bioreactor operations

Bioreactor operation optimization at the 50 L scale involves monitoring and controlling critical process parameters, as well as optimizing nutrient supplementation and feed strategies, while facilitating sterility and scalability. Implementing intensified fed-batch and perfusion processes can intensify the upstream process aimed at maximizing productivity, yield, and quality of the biopharmaceutical product.

Thermo Scientific DynaDrive Single-Use Bioreactors (S.U.B.)

The complete line of DynaDrive S.U.B.s include 50, 500, 3,000, and 5,000 L sizes that help ensure consistent scalability from pilot-scale studies to pre-clinical to commercial production.                                            

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 Controllers

Thermo Scientific HyPerforma G3 Bioprocess Controllers provide ease of data transferability and scalability throughout your process.                                                                                       

Harvest

The upstream harvest process is typically done through centrifugation or filtration. The clarified supernatant or filtrate is then further processed and purified in the downstream steps to obtain the final purified mAb product. Our single-use products have been developed to minimize the contamination risks while maximizing the separation efficiency.

Thermo Scientific fluid transfer solutions

Our fluid transfer assemblies are available as preconfigured standard designs and feature the BioTitan Retention Device, which offers minimized risk of leaks through a 360º seal.                                                                                                                                           

Thermo Scientific CentriPAK BioProcess Container

CentriPAK BioProcess Container (BPC) chambers, manifold, labtainer (sterilized) with connection. Designed for use in Thermo Scientific Sorvall BIOS 16 Bioprocessing Centrifuge and 6 x 2,000 mL or 8 x 2,000 mL Swing Bucket Rotor. Closed system for small scale harvesting process.                                                                      

Thermo Scientific DynaSpin Single-Use Centrifuge

With a growing need for process efficiencies and optimization, the DynaSpin Single-Use Centrifuge offers a robust single-use harvest solution that is designed to deliver superior separation and next-generation automation, adding significant value to drug manufacturing.                                                                                          


Downstream process

The monoclonal antibody downstream process—which includes affinity chromatography, virus inactivation, and polish steps—plays a crucial role in ensuring the purity, safety, and quality of the final product. These steps are designed to selectively purify the antibody, eliminate potential viral contaminants, and remove any remaining impurities or aggregates, ultimately yielding a highly pure and safe monoclonal antibody therapeutics.

Capture chromatography

Affinity chromatography is a widely used purification technique, where a specific ligand is immobilized on a chromatography resin to selectively bind and purify the monoclonal antibody from the complex mixture. This step allows for efficient separation and removal of impurities, resulting in a highly purified antibody. We developed an innovative portfolio of affinity chromatography resins, to help you solve challenges in the downstream process of antibody therapeutics.

 

Use our Bioprocess Resin Selection Tool to determine the right chromatography resin for your purification process.

MabCaptureC Protein A Chromatography Resin

Designed to help improve the productivity and efficiency of your antibody purification process, featuring high capacity and a highly cross-linked agarose backbone, making it the Protein A resin of choice for efficient process-scale purification of monoclonal antibodies.
 

CaptureSelect Affinity Chromatography Resins

CaptureSelect Affinity Chromatography Resins are developed to bind antibody-subdomain regions and are a key solution for the purification of mAb variant molecules such as bi-specific monoclonal antibodies, Fab fragments, and Fc-fusion proteins.                                                                   

DynaChrom Single-Use Chromatography System

Our Thermo Scientific DynaChrom Single-Use Chromatography System offers a wide range of flow rates and process volumes, making it a great choice for customers working from pilot to scale-up operations.


 

Viral inactivation

The viral inactivation process utilizes holding tanks and low pH conditions to enable viral inactivation as part of the product safety. This critical step in downstream processing is supported by a combination of single-use containers, fluid transfer assemblies, sample assemblies, and mixers regardless of volume. Our Production Chemicals and Sourcing Services include a portfolio of high-grade chemical brands for use in cGMP manufacturing, including acid and base solutions required for the pH dependent viral inactivation.

Polish chromatography

The polish steps in the mAb downstream process typically include an AEX resin followed with CEX and/or HIC resins to remove host cell proteins and residual DNA, aggregates, viral contamination, and other impurities. The polish step helps to ensure the final product's purity and quality. Simplify your downstream process of producing antibody therapeutics with the POROS chromatography resins and the DynaChrom Single-Use Chromatography System. Our Bioprocess Resin Selection Tool guides you through the suitable resin options for the downstream polish steps with some examples below.

POROS Hydrophobic interaction chromatography resin

The POROS HIC resin utilizes a novel coating procedure for functionalization with unique hydrophobic ligands, making it suitable for bind/elute and flow-through applications at lower salt concentrations and with higher binding capacity and resolution than classical HIC resins.

POROS Ion exchange resins

POROS resins provide an easy solution for ion exchange chromatography in bind/elute or flow-through modes of operation.                                                                                                                                                                                                                                                                                                                                                      

POROS Caprylate Mixed-Mode Cation Exchange Chromatography Resin

POROS Caprylate Mixed-Mode Cation Exchange Chromatography Resin is designed to reduce moderate to high levels of aggregates during downstream processing of therapeutic antibodies in flow-through mode.                          


Spend media 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 media and protein analytics to investigative projects, to help you make informed decisions to help improve performance.

Impurity testing

Impurity testing focuses on the identification and quantification of impurities present in the mAb production process. Impurities can include residual host cell DNA or proteins, and contaminations such as adventitious viruses, mycoplasma, or other microbes can occur across the production process.
 

The Applied Biosystems SEQ analytical testing solutions are part of an integrated real-time PCR workflow for impurity testing during biopharmaceutical manufacturing. Optional use of the Pharma KingFisher Apex 96 Deep-Well Magnetic Particle Processor with the PrepSEQ Sample Preparation Kits help to ensure high recovery of DNA with less labor and error than manual processing.

MycoSEQ Mycoplasma Detection System

Accepted by regulatory agencies for mycoplasma detection in a cGMP environment and does not require live mycoplasma for testing or process validation. Compatible with the Prep SEQ 1-2-3 Nucleic Acid Extraction Kit, optimized for highly efficient DNA recovery.

ViralSEQ Detection System

Detects all known MMV and Vesivirus strains. Compatible with the Prep SEQ 1-2-3 Nucleic Acid Extraction Kit, optimized for highly efficient DNA recovery.                                                                    


 

resDNASEQ dPCR CHO DNA Kit

Offers exceptional sensitivity and specificity, enabling reliable results for various sample types, including in-process samples and final product formulations. Compatible with the PrepSEQ residual DNA Sample Preparation Kit.                                                                                                               


Additional services to support process optimization

We offer wide range of additional services to help you to customize and find the best solutions for your mAb process beyond the of the shelf products. Find more information about the Media by Design services to optimize your cell culture process, and Custom Chromatography development services to resolve downstream process challenges.

Media and Feed Development Service

Our media development options include traditional, multi-omics and key driver identification workflows, allowing you the flexibility to characterize your process to help improve productivity.

Gibco Rapid Prototyping Service

Test the manufacturability and scalability of your formulation or optimize your existing formulations for cGMP scale-up.                                                            
 

Custom Chromatography Service

Our custom ligand and chromatography resin services enable the development of innovative purification resins, providing a solution for challenging downstream processes.                                                                 


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.

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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.