Quality Control
Statens Serum Institut's (SSI) Quality Control (QC) is cGMP compliant, and all analytical methods comply with Ph.Eur and upon request USP.
Our wide-range expertise in analytical methods is supported by valuable expertise in:
- Evaluation of SSI generic assays with costumer products
- Technology transfer of product specific assays
- Qualification and validation
- Stability studies on drug substances and drug products according to ICH guidelines
Standard analytical methods include (but are by no means limited to):
Active Ingredient analyses
-
Dotblot
-
ELISA
- HPLC-SEC
- HPLC-RP
- Immunogenicity and toxicity
- SDS PAGE (reduced/nonreduced)
- Various protein concentration methodologies
Physical/chemical analyses
- Appearance
- Conductivity
- Extractable volume
- Karl Fischer titrations
- Opacity
- Osmolality
- Particulate matter
- pH
- TOC (total organic carbon)
Microbiological analyses
- Bioburden
- Endotoxin determinations (LAL)
- Growth promotion/inhibition
- Sterility
Excipients and impurities
- Aluminium
- DNA Threshold
- Formaldehyde
- Glucose
- HPLC
- Western Blot
- Hydrogenperoxide
- Maltose
- Phenol
- Polysorbate 20
- Polysorbate 80
- SDS-PAGE
- Sucrose
- Urea
Last revised 13 October 2011