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    The importance of standardisation in the reproducibility of scientific results

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    In the field of biomedical and biotechnological research, one of the greatest challenges today is ensuring the reproducibility of results. Protocols, reagents and methodologies that lack standardisation not only generate variability between laboratories, but also affect the credibility of scientific findings.

    In this article, we address how this problem impacts scientific progress and what measures are being taken internationally to improve data quality.

    Why does the lack of standardisation compromise reproducibility?

    Science relies on reproducibility: if researchers cannot repeat a result in different laboratories under similar conditions, they compromise its validity.

    Some of the most common factors that cause this lack of consistency are:

    • Variations in reagents (different batches or suppliers).
    • Laboratory protocols that are not detailed or validated.
    • Instrumentation with different calibrations.
    • Absence of internal controls to ensure the reliability of the tests.

    The study of exosomes and extracellular vesicles clearly illustrates this challenge, as the diversity of isolation and characterisation methods complicates the comparison of results between different research groups.

    Initiatives and measures to improve reproducibility

    The scientific community and biotechnology companies are actively working on solutions that promote standardisation:

    1. International protocols and guidelines

    The International Society for Extracellular Vesicles (ISEV) and similar organisations have published detailed guidelines to standardise criteria for the isolation and characterisation of extracellular vesicles.

    2. Use of certified quality controls

    More and more companies are developing validated kits and standardised reagents, which reduce variability between experiments. These products include positive and negative controls, ensuring a more reliable interpretation of results.

    At Immunostep, we are working precisely on this approach, developing innovative solutions in flow cytometry and specialised reagents that help researchers obtain more consistent and comparable results.

    3. Transparency and open data

    The move towards open science encourages researchers to share their data, protocols and results on publicly accessible platforms. This promotes independent verification and international collaboration.

    4. Automation and digitisation

    Automation tools in laboratories and data management software reduce human error and ensure that procedures can be repeated exactly.

    Conclusion

    The lack of standardisation remains a major obstacle to scientific reproducibility. However, thanks to international initiatives, the validation of reagents and the adoption of more accurate technologies; the path towards more reliable and transparent research is advancing rapidly.

    At Immunostep, we believe that standardisation is key to accelerating scientific discovery and ensuring confidence in results.