Extensive bioanalytical and bioassay toolbox to ensure biosimilarity
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 of originator drugs to allow comparison.
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)
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
Outlicesing and partnerships available
“We are committed to positive outcomes and delivering projects on time to specification”
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.
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