Quality by design planning in ATMPs

Unqualified or inconsistent raw materials can derail therapeutic development, triggering revalidation, repeated process performance qualification (PPQ), and costly delays in Phase 2. For biotech and pharma teams, evaluating starting materials is essential to ensure product consistency and regulatory success.

Discover how robust GMP frameworks support raw material assessment for advanced therapies, from cancer cures to treatments for previously untreatable genetic disorders.