Feature
Building Quality into Advanced Therapies from Day One
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March 13, 2026
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7 min
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1
Regulatory agencies are adopting nuanced approaches for rare diseases.
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2
Maintaining high GMP standards is essential for safety.
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3
Quality is defined by understanding the product and process.
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4
Communication between CDMO and sponsors is crucial.
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Quality-by-Design should start early in development.
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6
A risk-based strategy is necessary for effective quality management.
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QA ensures compliance and patient safety throughout the process.
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8
Sponsors should prioritize CDMO capabilities that support early collaboration.
