mAbs Process Optimization and Intensification

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 buffers, process chemicals and dry powders and media manufactured with advanced granulation technology (AGT) helping you to reduce process steps and increase lot-to-lot consistency.

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.

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.

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.

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.

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.

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.

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.