PMID- 35398612
OWN - NLM
STAT- MEDLINE
DCOM- 20220428
LR  - 20220512
IS  - 1090-2104 (Electronic)
IS  - 0006-291X (Linking)
VI  - 608
DP  - 2022 Jun 11
TI  - FcgammaRIIIa-158V/F polymorphism affects the performance of FcgammaRIIIa-related 
      bioassay.
PG  - 149-155
LID - S0006-291X(22)00514-9 [pii]
LID - 10.1016/j.bbrc.2022.04.001 [doi]
AB  - Bioassays are important for estimating biosimilarity between biological products. 
      Comparability studies including bioassays are needed to demonstrate that a 
      biosimilar product has no meaningful differences that affect safety and efficacy 
      compared with the reference product. Among the most important biological 
      characteristics of therapeutic mAbs are Fc-mediated functions, which induce 
      immune-cell activation which can affect both efficacy and safety. Thus, when 
      developing biosimilar products of therapeutic mAbs, it is necessary to compare 
      the Fc-mediated functions by using various bioassays. Though it is reported that 
      polymorphism of Fcgamma receptors (FcgammaRs) affects Fc-mediated cellular activations of 
      therapeutic mAbs, the impacts of the polymorphism of FcgammaRs on bioassay 
      performance are still unclear. In this study, we evaluated the impact of 
      FcgammaRIIIa-158V/F polymorphism on assay performance in distinguishing differences 
      in the biological activities of therapeutic mAbs. The results showed that 
      different bioassay methods produced different assessments of biological 
      activities of mAbs, and that the FcgammaRIIIa-158V/F polymorphism clearly affected 
      the performance of the FcgammaRIIIa-binding assay using recombinant proteins and 
      FcgammaRIIIa-expressing reporter assays. That is, the assays using the FcgammaRIIIa-158F 
      variant were superior to those using the FcgammaRIIIa-158V variant in distinguishing 
      the difference in FcgammaRIIIa-binding and -activation properties. These results 
      indicate that we should evaluate the comparability of biosimilars by considering 
      the impacts of FcgammaRIIIa-158V/F polymorphism on bioassay performance.
CI  - Copyright (c) 2022 Elsevier Inc. All rights reserved.
FAU - Aoyama, Michihiko
AU  - Aoyama M
AD  - Division of Biological Chemistry and Biologicals, National Institute of Health 
      Sciences, 3-25-26 Tonomachi Kawasaki-ku, Kawasaki, Kanagawa, 210-9501, Japan.
FAU - Tada, Minoru
AU  - Tada M
AD  - Division of Biological Chemistry and Biologicals, National Institute of Health 
      Sciences, 3-25-26 Tonomachi Kawasaki-ku, Kawasaki, Kanagawa, 210-9501, Japan. 
      Electronic address: m-tada@nihs.go.jp.
FAU - Ishii-Watabe, Akiko
AU  - Ishii-Watabe A
AD  - Division of Biological Chemistry and Biologicals, National Institute of Health 
      Sciences, 3-25-26 Tonomachi Kawasaki-ku, Kawasaki, Kanagawa, 210-9501, Japan.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220405
PL  - United States
TA  - Biochem Biophys Res Commun
JT  - Biochemical and biophysical research communications
JID - 0372516
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Receptors, IgG)
SB  - IM
MH  - Antibodies, Monoclonal/pharmacology
MH  - Biological Assay
MH  - *Biosimilar Pharmaceuticals/pharmacology
MH  - Genotype
MH  - Polymorphism, Genetic
MH  - *Receptors, IgG/genetics/metabolism
OTO - NOTNLM
OT  - Assay performance
OT  - Bioassay
OT  - FcgammaRIIIa-158V/F polymorphism
OT  - Monoclonal antibody
COIS- Declaration of competing interests The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2022/04/11 06:00
MHDA- 2022/04/29 06:00
CRDT- 2022/04/10 20:26
PHST- 2022/03/01 00:00 [received]
PHST- 2022/04/01 00:00 [accepted]
PHST- 2022/04/11 06:00 [pubmed]
PHST- 2022/04/29 06:00 [medline]
PHST- 2022/04/10 20:26 [entrez]
AID - S0006-291X(22)00514-9 [pii]
AID - 10.1016/j.bbrc.2022.04.001 [doi]
PST - ppublish
SO  - Biochem Biophys Res Commun. 2022 Jun 11;608:149-155. doi: 
      10.1016/j.bbrc.2022.04.001. Epub 2022 Apr 5.