In her presentation, Irene del Molino del Barrio provided an insightful overview of her department’s work within GSK, focusing on the development, validation, and delivery of high-parameter flow cytometry panels. She explained that the department operates as a GCP laboratory, functioning almost as a mini CRO within GSK, supporting a wide range of clinical trials, with the exception of vaccines. The primary aim has been to explore immune signatures and mechanisms of action for drugs, with an ambition to transition towards secondary or companion diagnostics in the future.
Del Molino del Barrio highlighted the exponential growth in the complexity of flow cytometry, noting that panels now routinely exceed 30 colours, with some reaching as many as 50. This expansion enables the extraction of vast amounts of information from small samples, but it also introduces significant challenges in validation and reporting. The increased number of markers and plots complicates data comparison across trials, as differences in marker selection and gating strategies can hinder direct comparisons. She emphasised the necessity of rigorous validation and the difficulties posed by repetitive validation tasks.
To address these challenges, the team has implemented harmonisation and standardisation strategies. They have developed standardised panels with a common background and flexible “swapping slots” for specialised markers, which are shared with both internal and external partners. Instrumentation has also been harmonised across sites, facilitating cross-validation and ongoing comparability. The adoption of CDISC data standards, and the transition from the laboratory to the cellular biomarker domain, has improved data quality, regulatory compliance, and the potential for data mining.
Automation is a central theme in the department’s current and future work. Del Molino del Barrio described the integration of AI and machine learning, particularly in automating gating and quality control processes. Collaborations with the AI/ML team and software providers such as OMIQ are enabling more robust, multidimensional analysis, reducing manual workload, and enhancing consistency. The department continues to pursue full end-to-end automation, aiming for continual improvement and refinement in their workflows.
