Mejía-Calvo Ignacio, Muñoz-García Leslie, Jiménez-Uribe Alexis, Camacho-Sandoval Rosa, González-González Edith, Mellado-Sánchez Gabriela, Tenorio-Calvo Alejandra V, López-Morales Carlos A, Velasco-Velázquez Marco A, Pavón Lenin, Pérez-Tapia Sonia Mayra, Medina-Rivero Emilio
Unidad de Desarrollo e Investigación en Bioprocesos, Instituto Politécnico Nacional (IPN), Unidad Profesional Lázaro Cárdenas, Ciudad de México, México.
Departamento de Farmacología y Unidad Periférica de Investigación en Biomedicina Traslacional (CMN 20 de noviembre, ISSSTE), Facultad de Medicina, Universidad Nacional Autónoma de México, Ciudad de México, México.
Biotechnol Rep (Amst). 2019 Apr 18;22:e00331. doi: 10.1016/j.btre.2019.e00331. eCollection 2019 Jun.
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 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 (r>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.
生物治疗性I型干扰素（IFN-I）被用于治疗多种疾病。这些产品通过关键质量属性进行监管，以确保安全性和有效性。为此，需要开发可靠的检测方法，并进行验证以证明其适用于预期用途。尽管有一些用于评估IFN-I信号传导的商业试剂盒，但这些试剂盒侧重于测量生物学反应，而非进行验证，而验证是制药行业的要求。这项工作的目的是根据国际标准，在良好实验室规范下验证HEK-Blue IFN-α/β系统，评估IFN-α/β的生物活性。我们的结果表明，HEK-Blue IFN-α/β系统对IFN-α/β均符合准确性（r>0.95）、精密度（CV < 20%）和特异性要求；证实该检测方法对于这种生物治疗药物的评估是可靠的。因此，这种生物检测方法可作为质量控制环境下经典抗增殖和抗病毒检测方法的补充方法来实施。
