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 Culture Media Development
Cell culture media are complex mixtures of chemically defined nutrients to support healthy cell growth and maximize production of monoclonal antibodies and therapeutic proteins. Optimizing upstream production requires careful screening and selection of media, identification of an optimal feeding strategy for the given cell line, and selection of the production mode (batch, fed batch, or perfusion). The chosen media must also support the expansion of cells for GMP manufacturing.
Given the importance of cell culture media in bioprocessing, performance consistency, safety, as well as stringently qualified and documented raw materials are essential. Reliable sourcing of buffers is also critical to ensure reproducibility throughout the manufacturing process. Equally important is the need to prevent viral contamination from animal-derived ingredients and minimize the risk of mycoplasma contamination, both of which have the potential to affect drug supply and patient safety.
Our integrated offering for this cell culture media development encompasses the following categories:
- SAFC® Cell Culture Media (custom & off the shelf, fed batch and perfusion medium, bulk powder transfer bags)
- SAFC® Custom GMP and Pre-GMP Cell Culture Products (media, feeds, supplements, buffers)
- SAFC® Cell Culture Ingredients and Supplements (non-animal origin and animal-derived supplements, process chemicals, chemically defined feed, buffers)
- Millipore® Filters (media filtration: mycoplasma removal filters, sterilizing filters)
- Millipore® Single-Use Solutions (mixing, cryopreservation assembly, perfusion filter & controller, single-use assemblies)
- Millipore® / SAFC® Seed Train Expansion (medium, cryopreservation assembly, perfusion filter & controller)
- Millipore® Sampling Solutions (automated online system, offline systems, case)
- Millipore® / BioReliance® Services (raw material testing, equipment installation, system qualification, system training, system services, single-use and filter validation)
- Millipore® Automation and Analytics Software
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
- Optimizing Upstream Media and Feeds in Bioprocessing
Developing a robust upstream cell culture process that maximizes productivity without increasing complexity relies on the right combination of bioprocess medium and feed and the ability to maintain tight control of culture conditions.
- Improving Fed-Batch Yields in Upstream Bioprocessing
In this article, we’ll walk through media and feed screening strategies suitable for many cell lines and manufacturing scenarios using our EX-CELL® Advanced and Cellvento® Fed-batch platforms.
- Upstream Bioprocessing Feed Strategies and Scalability
Prior to scaling your upstream bioprocess to bioreactors, it’s best to set up small-scale cultures to determine the media and feed combinations. In this case study, we demonstrate this process using our Cellvento® ModiFeed Prime COMP feed.
- One-step Feed Optimization for Upstream Cell Culture Processes
Optimizing media and feed formulations is essential for efficient and cost-effective upstream workflows. Here we’ll discuss a one-step feed optimization using EX-CELL® Advanced CHO Feed 1 and Cellvento® 4Feed to improve monoclonal antibody (mAb) producing clones.
- Chemically Defined Media Supplements Improve Quality and Lower Risk in Upstream Bioprocessing
As a case study, we’ll take a look at how we created the chemically defined supplement EX-CELL® CD Hydrolysate Fusion and its performance in mAb-producing CHO cell lines.
- Cell Retention Technology and Specialized Cell Culture Media for Intensified Upstream Processing
This study demonstrates the use of a Cellicon® filter and controller in an N-1 perfusion process with Cellvento® 4CHO-X expansion medium as compared to a control seed train using shake flasks.
- Preparing CHO Cells for Higher Productivity by Optimizing a Perfused Seed Train
This application note describes the benefits and performance of Cellvento® 4CHO-X Expansion Medium designed for multiple cell expansion steps from vial thaw to N-1 stages to generate higher biomass for inoculating fed-batch production bioreactors.
- 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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