Process Development Research Laboratory
BIA Separations Process Development Research Laboratory provides purification process development to biopharmaceutical industry at highly competitive rates.
Our services include:
- Customized downstream process development according to customer’s needs and requirements
- Development of robust and efficient GMP-compliant processes covering all regulatory requirements
- Supporting analytical methods
Core Competencies
By applications:
- DNA purification
- Virus purification: human, plant and bacteriophages
- PEGylated protein purification
- Protein purification
- Ab purification (IgG, IgM, IgY, ...)
- Serum – plasma protein purification
By analytical methods:
- ELISA, PCR, real time PCR
- Cell-based assays for viral titer determination (TCID50, plaque assay, etc.)
- Western blot, Southern blot, SDS PAGE, agarose and 2D protein electrophoresis, densitometry
- Large particle size determination and distribution (Nanosight system)
- Protein, DNA and endotoxin determination and quantification assays (BCA, PicoGreen, LAL test…)
- Fast on-line virus titer quantification using chromatography
By process part:
- Upstream: eukaryotic and bacterial cells culture and harvesting,
- Downstream: TFF, Chromatography, Filtration, Sample preparation
- Final product formulation: Buffer exchange, Sterilization
By chromatography support:
- Classical particle columns: filling, testing, validation of all sizes (from sub-ml to tens of liters)
- CIM® monolithic columns: all available chemistries (ion exchange, hydrophobic, IMAC, affinities, special affinities …)
- Hydroxyapatite
Eq: 10 HPLC, peristaltic pump
By scale:
- Lab scale: couple ml of material, sub- mL column
- Industrial scale: thousands of liters of raw material, large columns
- Both scales fully cGMP compatible
