Eurofins BioPharma Product Testing Kyoto >> QC Services >> Biochemistry Services

Biochemistry Services

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Biopharmaceuticals have a complex structure compared to that of small molecular compounds. From the viewpoint of safety, it is important to use a combination a plurality of analytic methods and to perform detailed characteristic analysis and quality evaluation.

Test Item Analytical Method
Description Observation
Identity Peptide Map
Purity
  • Size exclusion chromatography
  • Reverse-phase chromatography
  • Ion-exchange chromatography
  • Affinity chromatography
  • Imaging capillary Isoelectric focusing
  • Capillary electrophoresis
  • SDS polyacrylamide gel electrophoresis
  • Western-blot
Impurities

[Residual Impurity Testing]

  • ELISA (host cell protein, Protein A)
  • Real-Time PCR (host cell DNA)
Potency ELISA, Cell based assay
Quantity UV
Others pH, Particulate Matter, Osmolality

 

Instrumentation Manufacturer and Model name

Chromatography

Agilent/Waters HPLC/UPLC

Detectors:
  • UV/VIS
  • Corona Charged Aerosol (CAD)

Capillary Electrophoresis

AB Sciex PA800 Plus

Protein Simple iCE3

Microplate Reader MOLECULAR DEVICES  SpectraMax M3, SpectraMax M4

q-PCR

ThermoFisher Scientific

QuantStudio 6 Flex Real-Time PCR System

UV-VIS Spectrophotometer SHIMADZU UV-2600