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Regulatory Challenges Associated with the Development of Cell and Gene Therapies

The development of safe and effective cell and gene therapies (CGTs) relies on regulatory compliance and critical selection and qualification of raw materials. Regulatory classifications for advanced therapy medicinal products (ATMPs) vary globally and it is imperative for both manufacturers and suppliers to understand the requirements and obligations from each party, to achieve international compliance. Marlin Frechette at FUJIFILM Irvine Scientific discusses the regulatory environment surrounding the biomanufacturing of CGTs and the significance of compliance with appropriate regulations to ensure the safety, quality, and efficacy of the final product.