Developing and Establishing a Platform for the Automation of Monoclonal Antibody Drug Analysis

Automation;Analytics;Monoclonal Antibody;Liquid Handling Robot;Chemical & Biomolecular Engineering

Federico, Joseph VincentGerecht, Sharon ;

Johns Hopkins University

关键词: Automation;    Analytics;    Monoclonal Antibody;    Liquid Handling Robot;    Chemical & Biomolecular Engineering;   

Others  :  https://jscholarship.library.jhu.edu/bitstream/handle/1774.2/60162/FEDERICO-THESIS-2018.pdf?sequence=1&isAllowed=y

瑞士|英语

来源: JOHNS HOPKINS DSpace Repository

【 摘 要 】

The use of automation has been standardized for generations in many industries, ranging from car manufacturing to oil refinery, and continues to advance at a rapid pace. While the power of automation has been harnessed in many other industries, the biotechnology sector has lagged behind, largely due to the complexity of working with biological matter as well as the complexity and the ever-changing nature of the processes involved.1 In recent years, the automation trend has gained in popularity in the field of biotechnology and many companies are seeking to utilize the new instruments and technology available to increase efficiency as well as optimize many other characteristics of their processes. Automation has the potential to significantly increase the overall productivity of a biopharmaceutical company by strategically implementing it where workflow traditionally slows due to bottlenecks, such as in analytical departments. Yet, in addition to improving efficiency, automation offers the unique ability of improving reproducibility and decreasing variation by transferring repetitive tasks to a robot. The elimination of human error and the ability to track all robotic movements well suits the ultimate goal of producing a high-quality product, which is of utmost importance in a good manufacturing practices (GMP) compliant environment.Currently, the standard for analyzing developmental drug samples is either by manually performed assays or on instruments dedicated to a particular assay. Therefore, we developed a customizable and versatile automated platform to replace a range of existing manual assays that test varying aspects of a monoclonal antibody drug sample.In this study, we used the Hamilton Microlab STAR robot to automate two relative drug potency assays and one residual Chinese Hamster Ovarian (CHO) host cell protein (HCP) assay. For all assays, all liquid handling steps are automated and performed by the robot. In this essay, we demonstrate that our automated assays can achieve equal or superior accuracy and precision compared to their manual counterparts, have a greater maximum efficiency, and track and record all robotic movements performed during the assay. Furthermore, our work establishes a precedent upon which future assays can be more easily translated into an automated environment.