TY - JOUR
T1 - Validation of a cell-based colorimetric reporter gene assay for the evaluation of Type I Interferons
AU - Mejía-Calvo, Ignacio
AU - Muñoz-García, Leslie
AU - Jiménez-Uribe, Alexis
AU - Camacho-Sandoval, Rosa
AU - González-González, Edith
AU - Mellado-Sánchez, Gabriela
AU - Tenorio-Calvo, Alejandra V.
AU - López-Morales, Carlos A.
AU - Velasco-Velázquez, Marco A.
AU - Pavón, Lenin
AU - Pérez-Tapia, Sonia Mayra
AU - Medina-Rivero, Emilio
N1 - Publisher Copyright:
© 2019 The Authors
PY - 2019/6
Y1 - 2019/6
N2 - The biotherapeutic type I interferons (IFN-I) are indicated to treat several diseases. These products are regulated to guarantee safety and efficacy through critical quality attributes. For this purpose, the development of robust assays is required, followed by its validation to demonstrate their suitability for its intended purpose. Despite there are some commercial kits to evaluate IFN-I signaling, these are focused on measuring in vitro biological response instead of their validation, which is a pharmaceutical industry requirement. The aim of this work was to validate the HEK-Blue IFN-α/β system evaluating the biological activity of IFN-α/β under good laboratory practices, according to international standards. Our results demonstrated that HEK-Blue IFN-α/β system comply with accuracy (r2>0.95) precision (CV < 20%) and specificity for both IFN-α/β; confirming that this assay is robust for this biotherapeutics’ evaluation. Thereby, this bioassay could be implemented as a complementary method to the classical anti-proliferative and anti-viral assays under quality control environments.
AB - The biotherapeutic type I interferons (IFN-I) are indicated to treat several diseases. These products are regulated to guarantee safety and efficacy through critical quality attributes. For this purpose, the development of robust assays is required, followed by its validation to demonstrate their suitability for its intended purpose. Despite there are some commercial kits to evaluate IFN-I signaling, these are focused on measuring in vitro biological response instead of their validation, which is a pharmaceutical industry requirement. The aim of this work was to validate the HEK-Blue IFN-α/β system evaluating the biological activity of IFN-α/β under good laboratory practices, according to international standards. Our results demonstrated that HEK-Blue IFN-α/β system comply with accuracy (r2>0.95) precision (CV < 20%) and specificity for both IFN-α/β; confirming that this assay is robust for this biotherapeutics’ evaluation. Thereby, this bioassay could be implemented as a complementary method to the classical anti-proliferative and anti-viral assays under quality control environments.
KW - Bioassay
KW - Biotherapeutic products
KW - Interferons α/β
KW - Receptor binding
UR - http://www.scopus.com/inward/record.url?scp=85064710779&partnerID=8YFLogxK
U2 - 10.1016/j.btre.2019.e00331
DO - 10.1016/j.btre.2019.e00331
M3 - Artículo
C2 - 31061815
AN - SCOPUS:85064710779
SN - 2215-017X
VL - 22
JO - Biotechnology Reports
JF - Biotechnology Reports
M1 - e00331
ER -