mAbs Upstream
Products for Development and Manufacturing.
The upstream workflow encompasses all steps leading to cell harvest including optimization of culture conditions, cell line and product characterization, media development, upstream process chemicals; and scale-up of the batch, fed-batch or perfusion process to larger bioreactors. The goal of upstream biomanufacturing is to increase cell density and product titer.
Cell Line Development
Cell line development is the process used to identify a highly productive, robust, and stable clonal cell line capable of expressing the molecule of interest at high titer and high quality. This step can be time consuming and resource intensive, and particularly challenging for complex antibodies such as bispecifics, but is essential to establish a suitable foundation for a successful bioproduction process.
Our integrated offering for this first cell line development step in the process of developing and manufacturing a therapeutic mAb is comprised of:
- SAFC® Ready-to-Use Cell Line Systems, Cell Line Engineering and Custom Development
- SAFC® Custom and Off the Shelf Cell Culture Media, Recombinant Supplements, Liquid Cell Culture Media and Buffers
- Millipore® CTDMO and BioReliance® Services (cell line development, cell bank manufacturing, cell line characterization)
- Millipore® Automation and Analytics Software
- Millipore® PAT Monitoring and Control
Related Categories
A cell line that maintains favorable growth and productivity is vital for mab manufacturing.
Our cell culture media makes your intensified or fed-batch processes more robust and efficient.
Our recombinant, non-animal origin (NAO) supplements are formulated for cell culture applications.
Mobius® single-use mixing solutions include a complete range of mixers from 10 L to 3,000 L.
The Mobius® Bioreactor family accommodates batch, fed-batch, and perfusion upstream processes.
Our broad portfolio of membrane filters offers options for efficient processing of every pharma and biopharma stream.
Related Resources
- White Paper: Use of a Chemically Defined Cloning Medium for Quality and Regulatory Risk Mitigation in Cell Line Development
Embark on a journey of discovery with chemically defined cloning medium, unveiling its tremendous potential in boosting cloning efficiency and streamlining molecular biology workflows to deliver unparalleled results.
- White Paper: Accelerating Cell Line and Process Development
This whitepaper describes the integration of technologies to more rapidly identify high-producing cell lines, strategies to optimize media feeds and a robust bioreactor scale-up approach to create a consistent and reliable solution for upstream bioprocess development.
- Datasheet: Cellvento® 4CHO-C Cloning Medium
This data sheet outlines the key benefits of Cellvento® 4CHO-C Cloning Medium.
- Datasheet: Bio4C ProcessPad™ Software
Bio4C ProcessPad™ software is a data collection, visualization, and analytics platform that enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV).
- Improved Process Understanding and Product Quality Through Continued Process Verification
Continued process verification is critical to maintain the strength, quality, and purity of the final drug product. It is a regulatory expectation as manufacturers are instructed to ensure their process remains in a continual state of control. Learn more in this technical article.
- Datasheet: Bio4C Orchestrator™ Software
This data sheet outlines the key benefits of the Bio4C Orchestrator™ Software as well as an overview of the dashboard, modules and requirements.
- White Paper: Automated Aseptic Sampling for Accelerated Access to process and Quality Data in Upstream Bioprocessing
This white paper focuses on PAT and the use of automated sampling technology to accelerate analytical and quality control methods and provide an approach for access to in-line data to monitor processes in real time.
- In-Line Real-Time Monitoring of CHO Cell Culture Process Parameters using Raman Spectroscopy
In this study, ProCellics™ Raman Analyzer with Bio4C® PAT Raman Software (the Raman PAT Platform) was used to monitor CHO cell culture parameters. Results were compared to more traditional off-line measurements to assess suitability of the technology for cell culture application.
- Seamless Integration of Glucose Control in CHO Culture Using Raman Spectroscopy
In this study, a ProCellics™ Raman Analyzer with Bio4C® PAT Raman Software (Raman PAT Platform) was used to implement a feedback control loop in a CHO cell culture process to monitor glucose concentration and enable maintenance of stable glucose levels without the need for manual intervention.
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