Process Development

The 19,000SF Genmab Product Development Lab is located 10 miles from the Brooklyn Park facility. This is a leased facility with a 2-year term that may be renewed. The primary focus was on late-stage development (tech transfer, scale up, process robustness, process validation) and manufacturing support.

Key Equipment in the facility includes:

Cell Culture – Upstream

  • Three 100L pilot-scale bioreactor systems and fourteen 2L benchtop bioreactors
  • Several incubators, biosafety hood, spinners, 20L wave systems
  • Nova Bioanalyzer, ABL-5, Cedex, ViCell, Osmometer, YSI

Downstream Recovery & Purification

  • Pilot-scale filtration skid and centrifuge for cell removal
  • Seven AKTA bench-scale chromatographic systems (0.01-10L)
  • Two AKTA pilot chromatographic skids (10-200L)Various ultrafiltration skids (500 mg to 250 g protein)Four filtration stations with automated data collection systems

Process Analytical Sciences

  • Lab group fully integrated with process groups to provide in-process analytical capabilities such as titer, aggregate, isoform, glycoform, residual DNA and Protein A analysis
  • Equipment capabilities in HPLC, SDS-PAGE, IEF, CE, quantitative PCR, ELISA plate reader, and UV/Vis spectrophotometry

Plymouth Facility Floor Plan