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
• Folding/misfolding
• Disulfide bridging and pairing
• N-terminal glutamine cyclization
• Clipping
• 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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