TY - JOUR
T1 - Physicochemical properties of Rituximab
AU - Flores-Ortiz, Luis F.
AU - Campos-García, Víctor R.
AU - Perdomo-Abúndez, Francisco C.
AU - Pérez, Néstor O.
AU - Medina-Rivero, Emilio
N1 - Funding Information:
This work was supported by CONACYT, Mexico grants INNOVATEC 134016. We thank Rodolfo Salazar, Alfonso Gómez, Alejandro Wiechers, Miriam Cedillo, and Anne de Mateos for their collaboration.
PY - 2014/6/15
Y1 - 2014/6/15
N2 - In order to demonstrate physicochemical comparability of a recombinant protein medicament as a drug substance (Active Pharmaceutical Ingredient or API), such as Rituximab, one must first choose suitable orthogonal analytical methods that selectively provide information regarding the identity and heterogeneity of the molecule. The application of these methods in the investigation of process-derived variability of the reference molecule can yield valuable information to establish comparability criteria. This could become the basis to determine the critical physicochemical attributes that should be verified by relevant in-process controls and batch release criteria. In this paper we show the determination and analysis of relevant attributes from two different proposed biosimilars. We show differences in Reditux proposed Rituximab biosimilar, mainly in charge heterogeneity patterns, whereas no major differences were found for Kikuzubam as related to the Mabthera reference batches. The detected differences are an indication of the capability of several analytical methods to show relevant physicochemical attributes during comparability exercises.
AB - In order to demonstrate physicochemical comparability of a recombinant protein medicament as a drug substance (Active Pharmaceutical Ingredient or API), such as Rituximab, one must first choose suitable orthogonal analytical methods that selectively provide information regarding the identity and heterogeneity of the molecule. The application of these methods in the investigation of process-derived variability of the reference molecule can yield valuable information to establish comparability criteria. This could become the basis to determine the critical physicochemical attributes that should be verified by relevant in-process controls and batch release criteria. In this paper we show the determination and analysis of relevant attributes from two different proposed biosimilars. We show differences in Reditux proposed Rituximab biosimilar, mainly in charge heterogeneity patterns, whereas no major differences were found for Kikuzubam as related to the Mabthera reference batches. The detected differences are an indication of the capability of several analytical methods to show relevant physicochemical attributes during comparability exercises.
KW - Biosimilar
KW - Charge variants
KW - Comparability
KW - Physicochemical properties
KW - Rituximab
KW - Stability
UR - http://www.scopus.com/inward/record.url?scp=84896134428&partnerID=8YFLogxK
U2 - 10.1080/10826076.2013.794738
DO - 10.1080/10826076.2013.794738
M3 - Artículo
SN - 1082-6076
VL - 37
SP - 1438
EP - 1452
JO - Journal of Liquid Chromatography and Related Technologies
JF - Journal of Liquid Chromatography and Related Technologies
IS - 10
ER -