mAbs 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.

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.

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.

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.

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

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.