Afifa Trad
Senior consultant, Pharma QA – GBA Key2Compliance
Advanced Therapy Medicinal Products (ATMPs) are transforming the treatment landscape for complex and previously untreatable diseases. By leveraging gene therapy, cell-based treatments, and tissue engineering, these therapies offer truly personalized solutions. But with innovation comes complexity—and success depends on one key factor: a robust strategy for quality and compliance.
ATMPs vs. Traditional Pharmaceuticals – What’s the Difference?
While traditional pharmaceuticals are typically small molecules or biologics produced under well-established frameworks, ATMPs are developed using living cells or genetic material. These are highly sensitive, variable products that require tailored processes and infrastructure. This complexity introduces unique challenges in ensuring product consistency, patient safety, and regulatory compliance—throughout the entire development and manufacturing lifecycle.
Why Quality Must Be Built In From the Start
Planning for quality is not a final checkbox—it’s a continuous process that should start early. Without a clear roadmap for compliance and knowing how to take the steps from research to considering and planning for commercial production, promising therapies risk regulatory delays, patient access barriers, and even commercial failure. A well-designed Quality Management System (QMS), combined with proactive risk management, lays the foundation for predictable, scalable, and regulatory-ready development.
Four Key Focus Areas for an Effective QMS Strategy
1. Product and Process Understanding
Define how your product behaves and what influences its safety and efficacy. This includes establishing control over manufacturing processes, critical equipment, and facility conditions—and confirming product performance against specifications.
2. Supplier and Outsourcing Oversight
Your critical materials and external partners directly impact product quality. Ensure qualification and continuous oversight of raw material suppliers, CMOs, and CROs through audits, quality agreements, and performance monitoring.
3. Documentation and Data Integrity
Good documentation practices support traceability, decision-making, and regulatory submissions. A structured, compliant approach to documentation is essential for ensuring data integrity throughout the product lifecycle.
4. Competence and Knowledge Management
Processes are only as strong as the people executing them. Build internal expertise, define roles and responsibilities, and invest in knowledge and quality know-how to maintain compliance as your project grows.
Common Challenges – and How to Tackle Them
One of the most pressing challenges in ATMP development is managing product variability. Living cells and genetic materials are inherently complex, requiring custom-built controls and flexible, phase-appropriate quality strategies. ATMP developers must also align with evolving regulatory expectations, often across multiple markets, adding another layer of complexity.
Early-phase decisions and understanding and mapping risks—on raw materials, process design, and documentation—can have long-term consequences. The earlier a quality framework is established, the easier it becomes to scale, adapt, and meet compliance standards without unnecessary rework or delays.
Moving From Concept to Patient – With Confidence
Quality should never be an afterthought. For ATMPs, it’s the critical enabler that transforms a scientific breakthrough into a safe, accessible treatment.
At Key2Compliance, we support ATMP developers throughout the product lifecycle—from early-phase strategy to clinical readiness and market approval. Our Pharma QA experts bring deep regulatory knowledge and hands-on experience of manufacturing and compliant processes to help you build scalable, fit-for-purpose quality systems.