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 : conductivity)
  • Total Organic Carbon (USP )
  • Heterotrophic Plate Count (APHA 9215B, 9215D)
  • Bacterial Endotoxins – LAL Kinetic Chromogenic method (USP )

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