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Of action. This is often an iterative process in which analytical similarity is tested and then further explored in preclinical biofunctional tests to determine whether minor differences, should they exist, result in differences in the biological activity of the molecule (Fig. 1). Confidence in the similarity of the molecule at this foundational step allows for a reduction in residual uncertainty
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Of action. This is often an iterative process in which analytical similarity is tested and then further explored in preclinical biofunctional tests to determine whether minor differences, should they exist, result in differences in the biological activity of the molecule (Fig. 1). Confidence in the similarity of the molecule at this foundational step allows for a reduction in residual uncertainty
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Oma H, Harashima S, Tsukamoto H, Shimoda T. Transmembrane TNF-a: structure, function and interaction with anti-TNF agents. Rheumatology. 2010;49(7):1215?8. Rosales C, Uribe-Querol E. Fc receptors: cell activators of antibody functions. Adv Biosci Biotechnol. 2013;4:21?3. van der Poel CE, Spaapen RM, van de Winkel JGJ, Leusen JHW. Functional characteristics of the high affinity IgG receptor, FcgRI.
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An DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177?3. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22): 3191?. Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8(5):431?. Liu J, et al. Assessing analytical si
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An DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177?3. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22): 3191?. Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8(5):431?. Liu J, et al. Assessing analytical si
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An DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177?3. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22): 3191?. Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8(5):431?. Liu J, et al. Assessing analytical si
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An DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177?3. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22): 3191?. Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8(5):431?. Liu J, et al. Assessing analytical si
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Ation of noncovalent complexes of recombinant human monoclonal antibody and antigen using cation exchange, size exclusion chromatography, and BIAcore. Analyt Biochem. 2001;299(2):119?9. Nesbitt A, Fossati G, Bergin M, Stephens P, Stephens S, Foulkes R, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Di