mAbs Development Manufacturing

Unique products and services designed to accelerate your antibody therapeutic to trial—faster

When people count on your monoclonal antibody (mAb) drug development, you need to make every minute count. With Thermo Fisher, you’ll have access to a robust and dependable portfolio of trusted solutions backed by years of proven and successful service.


From biomanufacturing expertise, innovative technologies, cGMP raw materials, and supply chain resiliency, you’ll find what you need to help accelerate your novel antibody therapies to those who need it most.


Media and buffer preparation

We collaborate with you to build workflows that offer consistency, flexibility, and simplicity in the earliest stages of clinical development, to help bring successful drug candidates through seamless tech transfers and into large-scale production.

Single-use mixers provide single-use mixing technologies for upstream and downstream applications ranging from 30 L to 5,000 L.


Cell expansion

We provide pioneering end-to-end products, process development, and customization services that can help maximize productivity while reducing costs and time-to-market.

Efficient-Pro Medium Feed helps deliver exceptional product performance, improved product titer, better protein quality, and lot-to-lot consistency.

Bacto CD Supreme Fermentation Production Medium is a dehydrated powder medium (DPM) designed specifically for fermentation applications to support high-cell-density cultures of Escherichia coli.


Cell culture production (Bioreactors)

We supply products specifically designed for easy scalability from research to commercial-scale manufacturing, supporting your scale-up process in its entirety—with a focus on easy implementation.

Single-use bench scale solutions offer consistent scalable bioreactors, controllers, and software from process development to cGMP manufacturing.


Harvest

Our resDNASEQ kit is a quantitative PCR (qPCR)-based assay designed and developed specifically to enable sensitive and accurate quantitation of residual host cell DNA.

The resDNASEQ CHO PrepSEQ kit for residual host cell DNA sample preparation is a magnetic bead based nucleic extraction and purification workflow, with exceptional recovery efficiency for applications where consistent absolute quantitation and high sensitivity detection are required.

The resDNASEQ Quantitative CHO DNA Kit is a quantitative PCR (qPCR)-based system optimized for the detection of host cell DNA from Chinese Hamster Ovary (CHO) cell lines used in the development of monoclonal antibodies and other biotherapeutics.


Capture chromatography

We developed an innovative portfolio of affinity chromatography resins, to help you solve challenges in the downstream process of next-generation antibody therapeutics.

CaptureSelect Affinity Chromatography Resins are developed to bind antibody-subdomain regions and are a key solution for the purification of novel antibody therapeutics (bi-specific monoclonal antibodies, Fab fragments, and Fc-fusion proteins), and are based on CaptureSelect technology, enabling increased purity and yield in a single purification step.

The MabCaptureC™ Protein A Chromatography Resin is 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.


Viral inactivation

We offer two main mixing platforms that address the needs of proper preparation of media, buffers, and other process liquids, designed for the liquid/liquid and powder/liquid mixing of media, buffers, intermediates, final products, process liquids, and suspensions.

Single-use mixers provide single-use mixing technologies for upstream and downstream applications ranging from 30 L to 5,000 L.


Polish chromatography

Simplify your downstream process of next-generation antibody therapeutics, with the use of POROS chromatography resins.

Hydrophobic interaction chromatography (HIC) is a versatile method for the purification and separation of biomolecules by using the function of hydrophobicity. HIC steps are commonly used at all steps in the process including capture step, intermediate, and final polish purification.

POROS chromatography resins address the industry bottlenecks caused by increased titers and product demands for antibodies and recombinant proteins. Through its high-resolution, high-capacity, and flow rate-independent performance, POROS chromatography resins help improve process throughput and flexibility.


Viral filtration

Our mixing systems are based on two different mixing systems—a bottom-driven impulse, and a top-down driven mixing system based on traditional stainless steel mixing principles, that address the needs of proper preparation of media, buffers, and other process liquids.

Our mixing platforms provide three main film platforms—mixing from 30 L to 5,000 L or any size in between—choice of mixer that best meets your application needs, and more.


UF/DF

We offer a fully integrated qPCR-based solution for the extraction and quantitation of host cell DNA manufactured and QC tested specifically for use in biopharmaceutical development and manufacturing.

The resDNASEQ system is a fully integrated assay leveraging real-time PCR technology for the quantitation of residual host cell DNA with a qualified DNA reference standard, featuring a complete residual host cell DNA testing workflow from sample preparation to results in less than 5 hours.


Bulk fill

Standard Single-Use BioProcess Containers (BPC) are ready-to-use, single-use flexible container systems that are cost-effective alternatives to conventional stainless-steel systems, that employ a novel design approach to help increase productivity.

Some of the well-established and well-known advantages of single-use systems such as the Labtainer Pro containers are lowered costs, reduced contamination risks, decreased facility footprint, increased flexibility, and production throughput efficiency with less cleanup—all designed to allow for a quick turnaround and increased production capabilities.


Catalog cGMP chemicals and supply chain services

Help minimize risks and accelerate milestones by working with a quality supplier that can provide support when you are ready to make the switch from research use only (RUO) to cGMP chemicals early in the biologic development process.

From pre-clinical trials to commercialization, our services allow you access to a portfolio of market-leading chemical brands through our expansive network of cGMP chemical manufacturers.

Learn more about Production Chemicals and Sourcing Services


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. 

Connect with a Bioprocessing representative or request more info.


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.


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