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Cell Culture Based Bioassays

The methods focus on measuring the physiological response of the therapeutic protein in-vitro. Methods are setup and developed according to analytical quality by design (QbD). Method qualification and validation is performed in accordance with the applicable guidelines, e.g. ICH Q2R1 and USP1032 to 1034.

Potency / Biological Activity Assays:

  • Cytotoxicity Assays (e.g. ADCC, CDC)
  • Apoptosis Assays (e.g. Caspase 3/7)
  • Proliferation / Anti-Proliferation / Inhibition Assays
  • Cell signaling / Cellular response Assays (e.g. cAMP)
  • Binding Assays
  • Cell activation assays

 

Virus Titer Assays

  • Virus
  • Virus like particles

 

Customized Assays, specifically developed for the molecule of interest

  • Whole blood assays
  • PBMC isolation
  • Reporter Gene Assays
  • Storage in the vapor phase of liquid nitrogen in a patented double jacket N2 tank (“dry storage”)

 

Cell Characterization and Maintenance under BSL1 and BSL2

  • Cell banking
  • Cell characterization (e.g. growth characteristics, generation of standard cultivation procedure)
  • Receptor Expression

Cryopreservation

  • Temperature monitoring
  • 24/7 on-call duty team
  • Storage in individual N2 tank, if required

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