Sample Preparation & Processing Enjoying efficiency
The implementation of automated sample preparation has delivered significant benefits to Ego Pharmaceuticals’ analytical and microbiology laboratories. The first method selected for redevelopment was quality control and stability testing for one of the company’s legacy products. The conventional procedure required multiple dilution and pipetting steps involving hazardous solvents, making it an ideal candidate for automation. By re-evaluating the existing process with the capabilities of the automated platform in mind – as well as applying green chemistry principles – solvent volumes were reduced from 200 ml to 20 ml, and chlorinated solvents were replaced with safer alternatives. These changes resulted in a
as well as implementing two-phase extraction for raw material analysis. These changes are expected to further enhance efficiency by replacing labour- intensive steps with automated operations.
Growing market pressures
The drive toward automation in chromatography sample preparation is not unique to Ego Pharmaceuticals. Across the pharmaceutical, biotech, and chemical industries, laboratories are increasingly turning to robotics and advanced automation to address similar challenges. The rise in sample screening, personalised medicine and complex biologics has increased the volume and complexity of
sample preparation as a potential bottleneck in its production, particularly given the diversity of its product portfolio. With over 120 products manufactured at a single site – all of which require rigorous testing of both raw materials and finished products – the need for adaptable and efficient processes is paramount. Manual methods were proving increasingly inefficient in meeting the demands of such a varied product range. Preparing samples for different types of analytical methods required constant switching between protocols, recalibration of instruments, and handling of multiple types of solvents and reagents. This variability increased the likelihood of human errors and could sometimes lead to inconsistent results, requiring costly and time-consuming reanalysis. Traditional automation systems are often excellent at handling specific workflows, but lack the adaptability to transition between different methods that are necessary. The company therefore needed an automated yet flexible sample preparation solution that could accommodate a wide range of analytical methods while minimising downtime and set-up requirements. The team investigated the various options on the market, and identified the ePrep® their requirements.
ONE as the best solution to meet
The drive toward automation in chromatography sample preparation is not unique to Ego Pharmaceuticals.
70% reduction in solvent usage, a 90% decrease in solvent costs, and a five-hour saving in operator time per test cycle. The automated system’s ability to run independently also allowed laboratory staff to focus on more value-added tasks, further improving overall efficiency.
Automation has also reduced the high failure rates associated with manual methods, streamlining workflows and ensuring that testing keeps pace with manufacturing. Encouraged by its early successes, the company has already extended automation to other procedures, including cleaning validations, standard preparations and serial dilutions. Plans are also underway to optimise additional processes, such as switching from high performance liquid chromatography (HPLC) to ultra-high performance liquid chromatography (UHPLC) for several methods,
analytical testing, meaning traditional manual methods can no longer keep up with demand without sacrificing accuracy or efficiency.
Regulatory pressures are also contributing to the adoption of automation. Agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require strict compliance with data integrity guidelines, which necessitate consistent, reproducible and fully documented processes. Automated systems that are designed to be FDA 21 CFR Part 11 compliant offer an advantage by reducing variability and providing complete traceability from sample preparation to final analysis to meet data integrity requirements. This not only ensures compliance but also reduces the risk of audit failures.
The ongoing skills shortage in analytical sciences is also driving the need for automation. Laboratories are struggling to recruit and retain experienced personnel, making it essential to use automation to streamline routine tasks and allow scientists to focus on more critical aspects of their work. In an industry increasingly influenced by robotics and artificial intelligence, Ego Pharmaceuticals saw the benefits of adopting technologies that improve productivity, accuracy and staff satisfaction early. Since many graduates now entering the workforce are trained with these advanced tools, making them available in the laboratory is critical for attracting and retaining talent. Automated sample preparation helps to ensure that skilled personnel are deployed where their expertise is most valuable, focussing on identifying targets, working on improvement projects, and spending more time reviewing chromatography results – including analysing data and trends.
Conclusion
Integrating innovative sample preparation solutions to automate its workflows has enabled Ego Pharmaceuticals to successfully remove bottlenecks, improve reproducibility and enhance overall laboratory efficiency, while maintaining its commitment to quality and continuous improvement. Ultimately, the adoption of automation in chromatography sample preparation represents more than just a technological upgrade, it’s a significant step to future-proofing laboratory operations. As analytical demands grow, automation will be a key differentiator, enabling companies to stay competitive, compliant and innovative in an ever- evolving industry.
ePrep ONE in situ
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