CMC for ATMPs: Tailoring Program Governance to Cell and Gene Therapy Complexity

Pawankumar Suresh

doi:10.5281/zenodo.17205347

CMC for ATMPs: Tailoring Program Governance to Cell and Gene Therapy Complexity

Author(s)	Pawankumar Suresh
Country	India
Abstract	Advanced therapy medicinal products (ATMPs), including cell and gene therapy, have short shelf life, and are customized manufacturing processes are increasingly gaining popularity. This presents unique difficulty to chemistry, manufacturing, as well as controls (CMC). Chain-of-identity and chain-of-custody need to be preserved, across the lifecycle of the product, and the distinctive governance needs of autologous workflows are often not considered by traditional CMC frameworks developed to support traditional biologics. This paper examines how tailor-made program governance practices have the potential to enhance the congruence between regulation compliance and ATMP operational realities. Focus is placed on the cooperation of digital supply chain management tools, global harmonized standards and flexible regulatory pathways. Chain tracking for increased patient safety and product integrity Case studies on regulatory convergence, comparability standards, and process optimization also focus on best practices regarding risk management and assurance of therapeutic efficacy. This publication highlights the importance of dynamic CMC governance systems to facilitate innovation and maintain patient-centric safety standards by proposing governance realignments that take account of real-time decision-making, regulatory variability around the globe, and the ethical aspects of engineered tissue and gene therapy development. The findings demonstrate that flexible but robust CMC governance models are required to transfer ATMPs out of the bench to the bedside in a manner that is compliant, effective, and scalable.
Keywords	CMC governance, Advanced therapy medicinal products (ATMPs), Cell and gene therapy, Short shelf-life management, Autologous workflows, Chain-of-identity, Chain-of-custody, Regulatory compliance, Comparability, Manufacturing strategy.
Field	Medical / Pharmacy
Published In	Volume 4, Issue 8, August 2023
Published On	2023-08-08
Cite This	CMC for ATMPs: Tailoring Program Governance to Cell and Gene Therapy Complexity - Pawankumar Suresh - IJLRP Volume 4, Issue 8, August 2023. DOI 10.5281/zenodo.17205347
DOI	https://doi.org/10.5281/zenodo.17205347
Short DOI	https://doi.org/g943n6

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CMC for ATMPs: Tailoring Program Governance to Cell and Gene Therapy Complexity

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