QMS for ATMPs: Quality Management Best Practices
Advanced Therapy Medicinal Products (ATMPs) encompass gene therapies, somatic cell therapies, and tissue-engineered products that offer transformative treatment potential for genetic disorders, cancers, and regenerative medicine applications. These innovative treatments present unprecedented quality management challenges due to their biological complexity, patient-specific manufacturing requirements, and sensitivity to process variations. Unlike traditional pharmaceuticals, ATMPs rely on living […]
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