mAbs Development and Manufacturing

Explore our interactive mAb platform solution and discover the innovative bioprocessing solutions designed to support your mAb development from discovery to commercialization.

Explore interactive workflow

Media and buffer preparation

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

Easy transition across scales, flow rates, sterile boundary requirements, and aliquot quantities with Thermo Scientific HyPerforma Single-Use Mixers (S.U.M.) and fluid transfer assemblies with a BioTitan Retention Device.

Save kitting time with ready-to-use Standard Single-Use Bottle Assemblies that reduce the burden of managing individual components or validating complex systems.

Cell expansion

We provide pioneering end-to-end solutions as well as 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.

Future-proof your process with single-use bench-scale products. Thermo Scientific HyPerforma Glass and Rocker Bioreactors offer open architecture process flexibility with Bioprocess Controllers and TruBio Software.

Cell culture production

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

Optimize yields with right-sized Thermo Scientific DynaDrive Single-Use Bioreactor (S.U.B.) and BioProcess Containers (BPCs). The DynaDrive S.U.B. streamlines the seed-train process and offers an exceptional turndown ratio for improved volumetric flexibility regardless of scale.

Optimize process development and streamline tech transfer with consistency in bioprocess control and automation software platforms, created with simplified solutions for PD and with cGMP compliance in mind.

Harvest

During the harvest step, efficient, process-specific products will aid in recovering cells, meeting desired high titer levels and helping enable 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.

The Thermo Scientific DynaSpin Single-Use Centrifuge provides a robust, sustainable single-use harvest solution that delivers superior separation and next-generation automation.

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

Viral inactivation, a critical step in downstream processing, is supported by a combination of standard manifolds, transfer assemblies, sample assemblies, BPCs, and hardware regardless of volume.

Improve the containment of your viral clearance steps in a modular format that is robust and easy to implement with our BioProcess Containers (BPCs) and fluid transfer assemblies with a BioTitan Retention Device.

Collaborate with our team of technical professionals to ensure you are getting the most value out of your single-use mixer operations during your viral inactivation process.

Polish chromatography

Simplify your downstream process of producing next-generation antibody therapeutics with the use of POROS chromatography resins and the DynaChrom Single-Use Chromatography System.

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.

The Thermo Scientific DynaChrom Single-Use Chromatography System is a complete solution for protein purification that provides flexibility and speed from process development to manufacturing.

Viral filtration

Depending on the process, a variety of unit operations and intermediate adjustments may occur in the pre-viral areas, including titrations, dilutions, depth or absolute filtration, and viral filtration prep. We offer single-use solutions that can accommodate all these applications.

Minimize the chances of carrying over a portion of the untreated pool into the next unit operations with our BPCs and fluid transfer assemblies secured with a BioTitan Retention Device for leak-proof operations.

Store and transport your BPCs in a durable and easily configurable outer support container like the Thermo Scientific Smartainer Storage Systems.

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

We offer both flexible and rigid containment as final drug substance storage solutions along with a series of plug-and-play single-use transfer assemblies to allow for a combination of sizes, flow paths, and variations.

Improve your bulk fill liquid handling for better ergonomics and to help eliminate the risk of leaks and failures with the Thermo Scientific Labtainer Pro Bioprocess Container (BPC) secured with a BioTitan Retention Device.

Choose the level of cleanness required for your application to enable quality and regulatory compliance with Nalgene Platinum Certified Clean Bottles and Carboys.

Catalog cGMP chemicals and supply chain services

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 can help minimize risks and accelerate milestones.

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

Scale to mAb production with speed, consistency, and flexibility

Creating a comprehensive and scalable mAb program is a difficult challenge, with many molecules failing to meet the rigorous safety and efficacy benchmarks necessary to reach the commercialization stage. Given this context, building workflows that offer consistency, scalability, flexibility, and high performance can help prepare for success and limit the time it takes to bring a successful drug candidate to market.

Whether you are in a development or production cycle, our team of scientific specialists has a proven track record of process support acting as a dedicated partner to meet your needs.

Scale up with Single-Use Products and Services