Laboratory Automation: What's Hot in 2022
Automating recurring workflows can help solve the reproducibility crisis in the natural sciences
In 2013, the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS) published a series of guidelines to establish best practices for cellular parameters detected by fluorescence. Since this first-time effort consensus is even greater to adopt these proposals for de novo assays of this category, which can offer valuable data for decision making on experimental therapies but be harder to reconcile with regulatory stipulations. Last year the National Institute of Standards and Technology (NIST) formed a consortium to obtain stakeholder-based consensus on how to improve stringency in flow cytometry measurements . For the same reason the Clinical and Laboratory Standards Institute (CLSI) recently published validation propositions for flow cytometry-based assays .
Utilized throughout drug development this technology has been deemed quasi-quantitative, but still lacks standardization. Its versatility enables a fit-for-purpose approach when establishing pharmacodynamic and biomarker detection methods with iterative refining of their performance. More of these will need to be validated early on however for cell and gene therapies, which add challenges for chemistry, manufacturing, and controls (CMC). Controlling the associated processes that require repetition and upscaling of sample volumes will involve or fully depend on data obtained from flow cytometry and cell sorting. Reducing one of the largest areas of variability starts at sample preparation. Automation can turn immunostaining into a largely hands-off procedure, for example. Solutions like these will help the global laboratory automation market expanding by US$ 2 billion on average over the next five years. Ultimately, more streamlining will not only make flow cytometry workflows more robust but help an emerging class of living drugs to hold its promise.
--Christoph Eberle, PhD, Principal Scientist, In Vivo Pharmacology/Oncology, Charles River
Our What's Hot series are annual forecasts provided by Charles River's thought leaders. Check out here what our scientists are predicting for 2022 and what they called out in years past.