We can establish and qualify physico-chemical and bioanalytical methods to fully characterize relevant target protein quality attributes, including in-depth analysis of post-translational modifications to match them to the originator.
- Quantity & strength
- Protein content (A280)
- Titer (Octet, APAC)
- Primary structure
- Amino acid sequencing
- Peptide map (RP-LC-MS)
- Variants & glycans
- Charge variants (HPC-CEX)
- Site specific deaminication by peptide mapping (RP-LC-MS)
- Site specific oxidication by peptide mapping (RP-LC-MS)
- N-linked Glycans (HILIC-FLR/MS)
- Aggregation & integrity
- Dimers/aggregates (HPLC-SEC/MALS)
- Fragments (CE-SDS)
- Purity & stability
- HCP (Elisa)
- hcDNA (qPCR)
- Residual protein A (ELISA)
- Thermo stability (nano-DSF)
- Safety
- Bioburden
- Endotoxin
- Sterility
- Mycoplasma