Development and application of an automated ELISA platform in QC laboratory
10.19778/j.chp.2026.01.014
- VernacularTitle:QC实验室自动化ELISA平台的开发与应用
- Author:
CHEN Jing
;
LI Boyang
- Publication Type:Journal Article
- Keywords:
ELISA;
relative potency;
automation;
quality control;
biologics
- From:
Drug Standards of China
2026;27(1):0109-0106
- CountryChina
- Language:Chinese
-
Abstract:
Objective: Biological potency assay, as a core component of biopharmaceutical quality control, directly influences drug efficacy assessments through the reliability of the methods. While ELISA-based potency assays accurately characterize drug-target interactions, traditional manual operations are often limited by cumulative operational errors, high variability, human errors, and low throughput.
Methods: A fully automated ELISA platform using the Microlab STARplus system was introduced by integrating high-precision pipetting modules with external devices.
Results: This platform not only meet accuracy and precision requirements but also significantly reduces variability compared to manual operations.
Conclusion: The platform enables a seamless, end-to-end workflow-from sample processing to detection, and standardized protocols and data traceability functions to effectively ensure data integrity.
- Full text:202606291126530941620260214.pdf
