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Building Quality into Advanced Therapies from Day One

Why early, risk-based thinking is critical in cell and gene therapy development

  • March 13, 2026

  • 7 min

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Julie Erwin, Head of Quality Assurance at ProBio US, discusses the evolving regulatory landscape in advanced therapies, emphasizing the need for a nuanced understanding of quality in relation to GMP standards. As the FDA adopts more flexible approaches for rare diseases, maintaining rigorous manufacturing standards is crucial. Effective communication, risk-based strategies, and a collaborative mindset are vital for success, especially for small biotech firms tackling complex challenges in cell and gene therapy development. Quality must be intentionally integrated from the earliest stages of product development.

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Building Quality into Advanced Therapies from Day One

  • March 13, 2026

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