(1278-C) Enhancing Molecular Lab Efficiency Through Comprehensive Automation of Bioanalytical Workflows
Tuesday, February 6, 2024
12:00 PM – 1:00 PM EST
Location: Exhibit Halls AB
Abstract: Regulated laboratories require careful attention in the development of molecular methodologies. The need arises from the inherent complexities within molecular techniques that demand stringent adherence to regulatory guidelines. These regulations encompass accuracy and precision validation, safety protocols, and compliance measures, which are fundamental for ensuring the reliability of the assay in either pre-clinical or clinical applications. Therefore, a comprehensive understanding and implementation of regulatory requisites in these laboratory settings stand as a critical cornerstone for the successful development and validation of molecular assays, impacting their efficacy and acceptance in GxP regulated practice.
This study evaluates the impact of integrating automation into a GLP regulated laboratory, with a focus on enhancing the bioanalytical workflows crucial for biodistribution, shedding, and persistence monitoring of cell and gene therapies – a routine focus of our molecular laboratory. These workflows involve nucleic acid isolation, quantification, and sample plating preceding quantitative polymerase chain reaction (qPCR). Historically, our laboratory has processed samples either manually or through semi-automated methods, where bottlenecks and potential errors can emerge during transitions from automated to manual processing, hindering efficiency.
To address these challenges comprehensively, our objective was to fully automate each stage of the workflow, aiming to standardize tasks and eliminate inefficiencies arising from partial automation. The implementation of automated systems successfully addressed bottleneck shifts between manual and automated steps and reduced our overall error (and repeat) rate. This holistic automation strategy prevented delays, optimizing the overall efficiency of molecular assays critical for the robust analysis of cell and gene therapies.
Comparative analyses between manual and automated workflows demonstrated that automated procedures yielded comparable results. Once optimized, the automated system consistently demonstrated precision and accuracy when pipetting, affirming its suitability for tasks traditionally handled manually by our analysts albeit at a larger scale. Notably, the adoption of automated magnetic bead-based DNA isolation significantly improved sample throughput, increasing efficiency eightfold compared to column-based procedures. Similarly, automated nucleic acid quantitation enhanced efficiency over threefold with minimal hands-on time by analysts. Furthermore, automated sample plating prior to qPCR provided a reliable and standardized approach, reducing common manual errors (e.g., dilution accuracy, pipetting errors) and minimizing assay-to-assay variability.
In summary, the integration of commercially available automation workstations into our molecular laboratory mitigated potential bottlenecks and maintained the quality and accuracy of results that are critical in regulated environments, offering a robust and efficient toolset for nucleic acid isolation, quantification, and qPCR plating. Beyond efficiency gains, the automation brought benefits such as walk-away time for parallel experiments, reduced risk of inadvertent cross-contamination, and improved lab safety through the automated handling of hazardous materials. This study underscores the significance of a fully automated workflow in advancing laboratory processes, promising heightened productivity, reproducibility, and safety within our production environment.