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)