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)