A Multidimensional Analytical Comparison of Remicade and the Biosimilar Remsima
Analytical Chemistry | May 2, 2017 | Read Now
Pisupati K, Tian Y, Okbazghi S, Benet A, Ackermann R, Ford M, Saveliev S, Hosfield C, Urh M, Carlson E, Becker C, Tolbert T, Schwendeman S, Ruotolo B, and Schwendeman A.
A rapid and rigorous analytical comparison of biosimilar mAbs using Protein Metrics’ Byologic® revealed clinically relevant differences in heterogeneity, and the potential to shrink the scope of clinical studies.
The mAbs were examined by native mass spectrometry, ion mobility, and quantitative peptide mapping, which provided robust analytical information about critical quality attributes (CQAs), e.g., oxidation, glycosylation profiles, glycation and the amount of aggregation.
The authors identified new, clinically relevant differences such as afucosylated glycans levels (RC, 19.7%; RS, 13.2%) and FcγRIIIa binding (RC, 162 nM; RS, 351 nM). Understanding these differences, which are a function of the cell line, can help biosimilar developers overcome the large challenges of optimizing cell line development and cell culture process optimization, to match the glycan distributions of the reference product. They are also critical to ensure a similar level of safety and efficacy of two products.
This study represents an example of a rapid and thorough examination of two products by an independent laboratory that can serve as a template workflow to reduce the complexity of data comparison and lab-to-lab variability in analytical methods and equipment.