With the upcoming patent expiration of therapeutic antibodies, the development of generic drug substances is a growing field.
Recombinant production processes may impact various parameters of biopharmaceuticals:
- Glycosylation pattern
- Amino acid substitutions
- Disulfide bridging and pairing
- N-terminal glutamine cyclization
- Deamidation (Asn -> Asp; Gln -> Glu; loss of epsilon-NH2 on Lys)
- Oxidation (Met, His, Trp)
Proteome Factory offers many services for this challenging field:
- Sequence verification by mass spectrometry (peptide mapping, intact mass determination) and Edman degradation (N-terminus or internal peptides)
- Glycosylation profiling
- PTM analysis
- Terminus characterization
- Mapping of deamidation sites, relative quantification
- Disulfide bridge analysis
Popular requests are:
Erythropoeitin (EPO), Darbepoetin (dEPO), Cetuximab (Erbitux™), Trastuzumab (Herceptin™), Infliximab (Remicade™), Natalizumab (Tysabri™) among others: Adalimumab, Aflibercept, Alemtuzumab, Basiliximab, Bevacizumab, Brentuximab, Canakinumab, Denosumab, Etanercept, Factor VIII, G-CSF, Golimumab, Ipilimumab, Mogamulizumab, Omalizumab, Pertuzumab, Ranibizumab, Rilonacept, Tocilizumab, Ustekinumab.
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