A path toward universal agreement on fulfilling the need for rapid and reliable sterility assays in gene therapy

Gene therapy has emerged as one of the most promising medical advancements, with the potential to cure previously untreatable diseases. Since the approval of Gendicine in China in 2004 for head and neck cancer, the field has gained momentum, with 33 gene therapies approved globally by Q4 2024. Over 2,100 gene therapy products are currently in development, underscoring a transformative shift in disease treatment [1]. However, this rapid growth highlights the critical need for innovation in sterility testing to ensure the safety and efficacy of these therapies delivered timely to patients.

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