Biopharmaceuticals(CDMO business) Research and development

Contract services

  • Description
  • Culturing and purification
  • Analysis
  • Characteristic analysis

Description

We offer services to support early-stage research in the development of biopharmaceuticals, from cell development to filling of active pharmaceutical ingredients for use in non-clinical studies and a full range of analyses.

We conduct testing in accordance with Standard of Reliability of Application Data.
We can also conduct design space studies in QbD.

Culturing and purification

We have a 200 L bioreactor, and we can accommodate culturing and purification processes from micro-plate scale to pilot scale.

Principal equipment
Major equipment Description
Incubators (2 units) For Screening of cell lines and optimization of medium
CO² incubators (3 units)
Micro-bioreactor Working volume:15 mL, 24 channels
For study of cultivation parameters
Jar fermentor Working volume:3 L (3 units) and 12 L (2 units)
For study of cultivation parameters and scale-up factor
Single-use bioreactor Working volume:200 L
For study of scale-up
Perfusion bioreactor For high density cell cultivation and study of continuous manufacturing
Refrigerated continuous centrifuge For removal of cells from culture medium
Chromatography systems small-scale (3 units) and pilot-scale (1 unit)
For study and optimization of purification parameters
Continuous chromatography For study of continuous chromatography
Tangential flow filtration For buffer-changing, concentrated and removal of virus
Freeze-Drying system For study of Freeze-Drying conditions

Analysis

We can perform protein analysis (molecular interaction, thermal stability, etc.) and gene analysis.

Principal equipment
Major equipment Description
HPLC 2 units
For protein analysis by chromatography.
Microplate reader Absorbance, fluorescence, and luminescence measurement
For expression analysis by ELISA and cell-based assay.
Molecular interaction analyzer For analysis of protein-protein molecular interactions
Micro-calorimeter 2 units
For analysis of protein thermostability
Particle size analyzer For analysis of protein particle size
qPCR For quantification of DNA concentration
DNA sequencer For identification of DNA sequences

Characteristic analysis

Allows us to analyze protein characteristics such as physical and chemical properties, purity, and impurities.

Types of analyses we can perform (partial list)
Type of analysis Description
Peptide mapping Analysis of amino acid sequences and modification using peptide measurement
Disulfide mapping Analysis of disulfide bond locations
Intact protein Precise analysis of molecular weight
C-terminal amino acid analysis Identification of C-terminal peptides using stable oxygen isotopes
Sugar chain analysis
(oligosaccharide)
Fluorometric and mass spectrometric analysis of glycosylated proteins
Purity analysis Evaluation of protein purity using SDS gel electrophoresis
Isoelectric focusing Measurement of isoelectric point by means of chemical mobilization
Oligosaccharide analysis Analysis of oligosaccharides using fluorescence labeling
Monosaccharide analysis Analysis of the structure of monosaccharaides using fluorescence labeling