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Automatic for the People

Eastern cultures tell us that 2023 is the year of the rabbit – and that those born this year will be vigilant, quick-minded, and ingenious. Those same characteristics should apply to all of us working in the life sciences industry, and I see an increased emphasis on them in the year ahead.

Following the challenges of the past few years, teams across the world are working hard to improve efficiency in different lab environments. It’s this determination that sets the tone for exciting research moving forward.

As we move through 2023, I am already seeing a renewed push for automation and a deep interest in how we can help create labs of the future through advanced analytics and workflow improvements.There is a global resounding message that scientists are under pressure to do more with less; they are being squeezed to process more samples and often with fewer resources. This extra demand comes as many labs are already under-staffed, putting significant strain and stress on current staff. With this increasing demand, there is an urgent need for workflow optimization and the elimination of waste – measures that must be implemented to keep staff physically and mentally safe in the lab.

Some lab disciplines are also facing a growing challenge of staff retiring without the next generation in place to take over. We must work to make lab work rewarding, exciting, and safe at every step so that it is an even more attractive career in the 21st century. 

One easy way to achieve this goal is to cut down on the strenuous and time-consuming manual workloads through automation – freeing staff to focus on their research and passion that brought them to life sciences in the first place.

With pioneering new technologies, we can help scientists automate their laboratories, increase efficiency, and control costs. I look at the evolution of stem cell analysis and transplantation as just one of many examples where workflows can be optimized – especially considering an estimated 100,000 stem cell transplants will be performed this year (1). We examined the situation and realized this workflow has not been updated in more than two decades – incredible when you think about what has changed in our everyday lives in the same timeframe! We worked shoulder to shoulder with customers to understand the process and seek improvements, realizing that, with a more streamlined and automated approach to this workflow, the average lab could save up to six hours a week.

As the life sciences industry continues to seek quality data to analyze and help drive decisions, I would expect big data and artificial intelligence (AI) to advance alongside it. The race is on to study existing drugs to identify potential additional uses for them, including treating illnesses that may lack current research investment. Big data also includes next-generation sequencing (NGS) – the global NGS library preparation and target enrichment market is projected to reach nearly $3.62 billion by 2030 (2).

With flow cytometry data, we are now able to measure many parameters simultaneously on a single cell level. The dimensionality of datasets has increased from traditional 4–5 color low parameters to 10–20 or more colors with many commercially available instruments. The sample size per experiment is also growing in terms of the number of events and number of samples collected. Machine learning-assisted analysis could play a key role in better understanding that data, and even allow for an automatic gating algorithm to both reduce variability and time. Manual gating is often cited as a major source of variability in cytometry assays in addition to being a time-consuming method (3). The more thorough the data analysis, the more quick-minded and ingenious labs can be with their decisions.

(Bio)pharma leaders will continue to look for that next big breakthrough moment with more research and testing still to be done – and this will be another exciting area to watch. A great deal was accomplished in 2022: the US Food and Drug Administration approved 37 new drugs, including therapies for COVID-19, HIV, and smallpox (4). I foresee that momentum continuing, with the potential for even more applications and trials as labs continue leaning into data and analysis.

In Europe, there will be a growing need for laboratories to prepare for the critical In Vitro Diagnostic Medical Devices Regulation (IVDR). Some compliance deadlines take place as early as May of 2024 and continue through 2028 (5). These new regulations could require workflow changes that can take several months – if not more than a year – to fully and successfully implement. I foresee a growing push for labs in the EU to ensure compliance for the first deadline.

The regulations will primarily affect Laboratory-Developed Tests (LDTs) – an area that hasn’t seen many changes in the EU since 1993. IVDR is designed to ensure that IVD products achieve the highest levels of safety and efficiency. Though IVDR is regionally focused, we know much of the world will be watching – with IVDR potentially becoming a global standard. With this knowledge, our team aimed to get ahead in supporting lab requirements. Since our start of this project in 2018, there are currently more than 200 reagents for flow cytometry that are IVDR compliant and produced at certified manufacturing sites around the world (6). The more companies that get behind this innovation of the life science industry, the more we can discover.

Though challenges remain, if we pull together and prioritize goals and strategies with an open mind, we can all reap the rewards of a better tomorrow. And by letting automation do the heavy lifting and provide the information, we can perform like those born in the year of the rabbit: quick-minded, vigilant, and ingenious.

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  1. D Niederwieser et al., One and Half Million Hematopoietic Stem Cell Transplants (2019). DOI: 10.1182/blood-2019-125232
  2. NGS Library Preparation Market to Reach $3.62 Billion by 2030 (2023). Available at: https://bit.ly/3C9YaoZ 
  3. HT Maecker et al., Standardization of cytokine flow cytometry assays (2005). DOI: 10.1186/1471-2172-6-13
  4. FDA, “New Drug Therapy Approvals 2022” (2023). Available at: https://bit.ly/3OTPafh 
  5. European Commission, “Regulation of the European Parliament and of the Council” (2023). Available at: https://bit.ly/3Oyt5Cv 
  6. European Commission, “Economic Operator Devices” (2023). Available at: https://bit.ly/3WxmwC7
About the Author
Suzanne Foster

Suzanne Foster is President of Beckman Coulter Life Sciences, Indianapolis, USA

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