New End to End Automation Platform for Enhanced clinical specimen testing Efficiency and Precision in Clinical Biomarker Laboratory

Authors.
Juan Reyes1, Bhaskar Sarmah1, Suresh Chickanna2, Al Reynolds1, Aniketh Prakash1, Kaity Gonzales1, Jessica Mason1, Brooke Remsen1, Elijah Gaspard1, Liang Zhu1, and Paul C Trampont1, 
Affiliation.
1 Moderna Therapeutics, Clinical informatics, Clinical Biomarker, Norwood, MA, 02062
2 Moderna Therapeutics, Clinical Biomarker Laboratory, Norwood, MA, 02062
 Correspondence is sent to: paul.trampont@modernatx.com

Abstract. (Word count =142, character count= 953)
Hemagglutination Inhibition Assays (HAIs) play a crucial role in clinical biomarker analysis, providing valuable insights into immune responses and vaccine efficacy. However, manual execution of HAI assay can be time-consuming, labor-intensive, and prone to variability. This abstract presents a novel end to end HAI Automation Platform designed by and for the Clinical Biomarker Laboratory at Moderna. The platform aims to streamline and optimize the HAI workflow, enabling clinical scientific staff to achieve higher throughput, improved accuracy, and reproducibility in clinical phase studies.
The HAI Assay Automation Platform combines cutting-edge technologies, including robotic liquid handling systems, integrated plate readers, robotic incubator, centrifuges, plate sealer, peeler, and advanced data analysis software. These features facilitate seamless collaboration between scientists and the platform, resulting in an efficient and error-free interaction that maximizes productivity and minimizes variability across data obtained from clinical specimen during clinical phase studies.
Introduction.
The key features of the Hemagglutination Inhibition Assay Automation Platform include:
Integrated Robotic platform: The HAI Assay Automation was developed at the Clinical Biomarker Laboratory (CBL) with our partnership with Thermo Fisher and using the InSPIRE platform with its Momentum scheduling software. InSPIRE automation and robotics is a vertically oriented collaborative platform that provides control of devices in an automated system, allowing users to design a virtual version of a physical laboratory system and supports a wide variety of automated laboratory systems through Momentum Automation Management Software.
This has allowed Moderna to create a product that increases its throughput capabilities, creates an audit trail that can be validated in a GCLP compliant environment and more importantly it delivers quality data across clinical phase studies. InSPIRE allows the flexibility to bring on third party components and integrate it with Momentum software. The process was developed based on Moderna’s CBL lab standards but optimized to fully utilize each automated component to its full extend. The platform has been digitally qualified, validated experimentally under a GCLP environment to take upon Clinical phase studies. Currently the system is run by 2 technical staff to perform approximately 2000 clinical tests a week, compared to 9 individuals running 1200 tests a week.
Automated liquid handling: The platform utilizes two advanced robotic liquid handling systems to accurately dispense samples, reagents, and controls, reducing human error and enhancing assay reproducibility. Hamilton Starlet is used for reading tube barcodes, decap/cap tubes and dispensing sample into a deep well plate. Hamilton Star is used for the serial dilution of the samples.
FluHema plate reader: The platform incorporates the FluHema plate reader by SciRobotics, it has imaging and analysis capabilities with high sensitivity and rapid data acquisition, enabling real-time monitoring and analysis of assay results. The plate reader uses its powerful vision algorithm to identify positive and negative wells.
Robotic Incubators: The platform incorporates five Cytomat robotic incubators. This allows a larger number of samples simultaneously, allowing for higher throughput and increased productivity. Using the Momentum scheduling software we are able to guarantee each sample is maintained at the desired temperature and incubation time.
Data analysis and visualization: The platform provides intuitive software interfaces for data transfer, analysis, visualization, facilitating efficient interpretation and reporting of HAI results.
Quality control and traceability: The platform incorporates comprehensive quality control measures and data tracking functionalities, ensuring assay accuracy, and providing traceability for regulatory compliance.
The introduction of this new HAI Automation Platform holds immense potential to revolutionize Moderna’s Clinical Biomarker analysis. By automating the HAI workflow, the platform significantly reduces assay turnaround time, enhances accuracy, and improves reproducibility, enabling researchers to make more informed decisions in clinical research and vaccine development.
This abstract invites attendees of the SLAS conference to explore the capabilities and benefits of this new HAI Assay Automation Platform for clinical biomarker analysis. The presentation will include demonstrations and case studies showcasing the platform's effectiveness in improving workflow efficiency, data quality, and overall biomarker analysis outcomes.