跳转至内容
Merck
CN

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 Products
Loading

Related Categories

A scientists looks at a sample on a microscope.
Bioprocessing Cell Lines

A cell line that maintains favorable growth and productivity is vital for mab manufacturing.

Learn More
Bioprocessing Cell Culture Media
Bioprocessing Cell Culture Media

Our cell culture media makes your intensified or fed-batch processes more robust and efficient.

Learn More
Process scientist working with cell culture media
Bioprocessing Recombinant Supplements

Our recombinant, non-animal origin (NAO) supplements are formulated for cell culture applications.

Learn More
Mobius® Power MIX: the mixing solution of choice for hard-to-dissolve materials and buffer preparation
Single-Use Mixers

Mobius® single-use mixing solutions include a complete range of mixers from 10 L to 3,000 L.

Learn More
The Mobius® Single-Use Bioreactor family of products can be seen.
Bioprocessing Mobius® Single-Use Bioreactors

The Mobius® Bioreactor family accommodates batch, fed-batch, and perfusion upstream processes.

Learn More
A female scientist wearing protective goggles holds up a sterile drug product.
Sterile Filters

Our broad portfolio of membrane filters offers options for efficient processing of every pharma and biopharma stream.

Learn More

Related Resources

1/2




Explore Our Solutions

登录以继续。

如要继续阅读,请登录或创建帐户。

暂无帐户?