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The Inno Bio QC Department is primarily involved with analytical method development, method validation and routine testing. All testing is carried out with a high degree of stringency, to ultimately ensure that the quality, purity and stability of the end-product are assured.
We offer the following services:
Laboratory Analytical Testing Services
- Fully compliant with PIC/S and FDA cGMP guidelines.
Water testing
- Inorganic contaminants (Al, NO3, NH3, Si, Hardness, Chlorine)
- Heavy Metals Limit test (EP/BP)
- Physico-chemical parameters (Silt Density Index, turbidity, pH, USP <645> : conductivity)
- Total Organic Carbon (USP <643>)
- Heterotrophic Plate Count (APHA 9215B, 9215D)
- Bacterial Endotoxins – LAL Kinetic Chromogenic method (USP <85>)
Instrumental and Chemical analysis
HPLC-UV, Fluorescence, RI
- Purity tests
- Identification – peptide digestion
- Molecular weight determination
- Impurity, degradation analysis
Capillary electrophoresis
- cIEF, CZE
- Purity, impurities, molecular weight, identification
ESI-MS/MS
- Intact mass
- Peptide digests
- Peptide sequencing
- Glycosylation analysis
- Post-translational modifications
Others
- UV/Vis
- Flame AAS – raw material analysis
- Biochemical analysis of cell culture nutrients / metabolites (pH, glutamine, glucose, lactate, glutamate, potassium, sodium, NH4, osmalality)
- FT-IR– identification of organic compounds
- Chemical tests of raw materials – according to BP/EP/USP requirements
Biochemical Analysis
- SDS-PAGE and native PAGE
- Iso-electric focusing
- Western Blots
- ELISA and other microplate analyses
- Total Protein
Microbiological Analysis
- Bacterial identification (BBL Crystal™)
- Bacterial endotoxins
- Environmental monitoring
Cell Line Characterisation
- Mycoplasma detection (MycoAlert™)
- Bacteria, yeasts, moulds
- Isoenzyme analysis
Stability Testing
- Stability testing according to ICH guidelines (ICH Q5C, Q1A, Q1D, Q1E)
- Photostability testing (ICH Q1B)
- Real-time and stress/ accelerated stability
Bioassays
- Mammalian cell-based bioassays
- Cell proliferation assays
- Cytopathic assays
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