Standardisation, digital maturity and the path ahead in cell and gene therapy

Published: 19-Nov-2025

With the promise of more personalised and potentially curative treatments, regulatory agencies are forecasting a surge in cell and gene therapy (CGT) approvals, reports Dr Matthew Lakelin, Head of Consultancy Services at TrakCel

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As the industry scales up, however, it faces growing pains that extend well beyond scientific complexity.

Standardisation, digital maturity and the path ahead in cell and gene therapy

Variability in regulatory frameworks, along with a fragmented digital ecosystem and inconsistent levels of technological adoption, are all placing pressure on the sector to evolve.

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