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GMP Lot Release and Stability Testing

Lot release or finished product testing is a crucial part of ensuring biologics quality and safety through evaluation of purity, potency and identity.

Stability testing demonstrates short and long-term stability of a biologic after exposure to a variety of environmental factors.

Our testing services include:

  • Compendial pharmacopoeia methods including appearance, osmolality, pH,
  • Size Exclusion Chromatography (SEC)
  • Reversed-Phase Chromatography (RP-LC)
  • Ion-Exchange Chromatography
  • Peptide mapping
  • Glycan profiling
  • Capillary Gel Electrophoresis (CGE-R, CGE-NR)
  • Capillary Isoelectric Focussing (cIEF)
  • Amino acid analysis
  • Protein concentration determination
  • Host Cell Protein (HCPs) and Host Cell DNA (HCD) determination
  • Cell-based bioassays (through our cGMP-accredited partners)
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