TY - JOUR
T1 - In vitro methods for comparing target binding and CDC induction between therapeutic antibodies
T2 - Applications in biosimilarity analysis
AU - Salinas-Jazmín, Nohemi
AU - González-González, Edith
AU - Vásquez-Bochm, Luz X.
AU - Pérez-Tapia, Sonia M.
AU - Velasco-Velázquez, Marco A.
N1 - Publisher Copyright:
© 2017 Journal of Visualized Experiments.
PY - 2017/5/4
Y1 - 2017/5/4
N2 - Therapeutic monoclonal antibodies (mAbs) are relevant to the treatment of different pathologies, including cancers. The development of biosimilar mAbs by pharmaceutical companies is a market opportunity, but it is also a strategy to increase drug accessibility and reduce therapyassociated costs. The protocols detailed here describe the evaluation of target binding and CDC induction by rituximab in Daudi cells. These two functions require different structural regions of the antibody and are relevant to the clinical effect induced by rituximab. The protocols allow the side-to-side comparison of a reference rituximab and a marketed rituximab biosimilar. The evaluated products showed differences both in target binding and CDC induction, suggesting that there are underlying physicochemical differences and highlighting the need to analyze the impact of those differences in the clinical setting. The methods reported here constitute simple and inexpensive in vitro models for the evaluation of the activity of rituximab biosimilars. Thus, they can be useful during biosimilar development, as well as for quality control in biosimilar production. Furthermore, the presented methods can be extrapolated to other therapeutic mAbs.
AB - Therapeutic monoclonal antibodies (mAbs) are relevant to the treatment of different pathologies, including cancers. The development of biosimilar mAbs by pharmaceutical companies is a market opportunity, but it is also a strategy to increase drug accessibility and reduce therapyassociated costs. The protocols detailed here describe the evaluation of target binding and CDC induction by rituximab in Daudi cells. These two functions require different structural regions of the antibody and are relevant to the clinical effect induced by rituximab. The protocols allow the side-to-side comparison of a reference rituximab and a marketed rituximab biosimilar. The evaluated products showed differences both in target binding and CDC induction, suggesting that there are underlying physicochemical differences and highlighting the need to analyze the impact of those differences in the clinical setting. The methods reported here constitute simple and inexpensive in vitro models for the evaluation of the activity of rituximab biosimilars. Thus, they can be useful during biosimilar development, as well as for quality control in biosimilar production. Furthermore, the presented methods can be extrapolated to other therapeutic mAbs.
KW - Anti-CD20
KW - Biosimilar
KW - CDC
KW - Daudi cells
KW - Flow cytometry
KW - Immunology
KW - Issue 123
KW - Rituximab
KW - Therapeutic mAb
UR - http://www.scopus.com/inward/record.url?scp=85018934168&partnerID=8YFLogxK
U2 - 10.3791/55542
DO - 10.3791/55542
M3 - Artículo
C2 - 28518088
AN - SCOPUS:85018934168
SN - 1940-087X
VL - 2017
JO - Journal of Visualized Experiments
JF - Journal of Visualized Experiments
IS - 123
M1 - e55542
ER -