Analytics & bioassays

We have an extensive analytical and bioassay toolbox that ensures biosimilarity, including in-depth analysis of post-translational modifications to match them to the originator. We also have access to a wide range originator drugs to allow comparison.

Analytics

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

Bioassays

We have also developed a toolbox of bioassays especially designed for comparing biosimilar activity to originators. These include:

Binding (ELISA)
Cell based assays
Membrane bound antigen binding (FACS) on living cells
Classical ADCC assay using our proprietary affector cell line
CDC assay
FcgR Binding (CD16V, CD16F, CD32, CD64 and FcRn) on living cells

Our analytical and bioassay services are designed to support our partners development projects to ensure the quality and purity of their therapeutics. However we will support any standalone project so we can accelerate your product to patients.