Biotech products＿Contract development
Application
(1) Protein expression
Stable cell line development
API develops and establishes stable cell lines in mammalian and insect cell systems.
Available expression system : CHO-DG44 and CHO-S (mammalians), and S2 (insect)
Transient expression by mammalian cells or insect cells (bacurovirus)
API provides transient protein expression systems using mammalian cells and insect cells (baculovirus system), which produce recombinant proteins and antibodies on a scale of microgram to gram in a short period of time.
Transient expression by S2 cells
API provides a transient protein expression service using D. melanogaster S2 cells. Expression profiles of GFP, Activin A, IL-4 and GM-CSF are shown above as examples.
(2) Upstream Process Development
Development of cell culture processes.
- Optimization of culture media and feeds
- Optimization of culture parameters (e.g., stirring speed, pH and dissolved oxygen conc.）
- Scale-up from flask to 200 L reactor scale
(3) Downstream Process Development
Development and optimization of purification processes.
- Optimization of chromatography conditions (e.g., AFC, IEX, HIC and SEC)
- Resin lifecycle study
- Column packing
- Selection and sizing of membrane filters
- Scale-up of purification processes
(4) Analysis
Analytical development
- Protein analysis, biochemical assays, cell-based assays
- Validation of analytical methods
- Technology transfer of analytical methods
- Consulting of SOP improvement and optimization of analytical methods, and support for IND application
- Setting of quality test procedures and acceptance criteria for new drug products
