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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. 

Bioreactors

Bioreactors are available in a range of sizes and formats (stainless steel, single-use, or hybrid) to support both adherent and suspension cell cultures. Adherent cell lines can be grown in batch or fed-batch modes, or with media exchange, while suspension cells can be grown in batch, fed-batch, and perfusion modes. Regardless of the cell type or operating mode, the bioreactor must enable consistent cell growth, high cell viability, and robust protein production. During process development, scaled-down, small working volume microbioreactors are used to predict the performance of larger scale vessels, facilitating the process of scale-up for clinical and commercial production or tech transfer. 

Our comprehensive offering around the bioreactor includes:

  • Millipore® Single-Use Bioreactors With or Without Cell Retention System for Perfusion Operations
  • Millipore® Sterilizing Filters & Prefilters
  • Millipore® Sampling Solutions (automated online system, offline sampling)
  • Millipore® Process Analytical Technology (Raman Analyzer, automated aseptic sampling)
  • Millipore® CTDMO, BioReliance® / Millipore® Services (cell and viral bank testing, raw material testing, bulk harvest release testing / single-use and filter validation, equipment installation, system qualification, system training, system services)
  • Millipore® Automation and Analytics Software
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