Research Articles
Navigating the Maze: A Strategic Comparison of EU and US CMC Requirements for Cell Therapies
This article provides a comprehensive comparison of Chemistry, Manufacturing, and Controls (CMC) requirements for cell therapies in the European Union and United States.
Navigating EMA vs FDA Cell Therapy Potency Testing: A Strategic Guide for Global Development
This article provides a comprehensive comparison of the European Medicines Agency (EMA) and U.S.
Overcoming Limited Batch Challenges: A Strategic Guide to ATMP Process Validation
This article provides a comprehensive framework for researchers, scientists, and drug development professionals navigating the significant challenge of validating manufacturing processes for Advanced Therapy Medicinal Products (ATMPs) with a limited...
Navigating ATMP Manufacturing Inspections: A 2025 Guide to Addressing Deficiencies and Ensuring Compliance
This article provides a comprehensive guide for researchers, scientists, and drug development professionals on addressing common Good Manufacturing Practice (GMP) deficiencies in Advanced Therapy Medicinal Product (ATMP) facilities.
Navigating EU Comparability for Cell Therapy Process Changes: A Strategic Guide to CMC, Compliance, and Market Success
This article provides cell therapy researchers, scientists, and drug development professionals with a comprehensive framework for managing comparability in the European Union.
Navigating GMP Compliance in Cell Therapy Manufacturing: Strategies for Quality, Safety, and Scalability
This article provides a comprehensive guide for researchers, scientists, and drug development professionals addressing the critical challenge of GMP non-compliance in cell therapy manufacturing.
Navigating Point-of-Care Cell Therapy Manufacturing: A 2025 Guide to EU Regulations and Decentralized Production
This article provides a comprehensive analysis of the evolving regulatory landscape for point-of-care (POC) and decentralized manufacturing of cell and gene therapies in Europe.
Environmental Risk Assessment for GMO ATMPs in the EU: A Comprehensive Guide for Developers and Researchers
This article provides a detailed guide to the Environmental Risk Assessment (ERA) process for Advanced Therapy Medicinal Products (ATMPs) containing Genetically Modified Organisms (GMOs) in the European Union.
Navigating Cell Therapy ATMP Process Validation: Strategies for Compliance and Commercialization
This article provides a comprehensive guide to process validation for cell therapy Advanced Therapy Medicinal Products (ATMPs), addressing the unique challenges faced by researchers and drug development professionals.
Batch Certification for Cell Therapies in the EU: A Guide to ATMP Compliance, Quality Control, and QP Release
This article provides a comprehensive guide to the batch certification process for Advanced Therapy Medicinal Products (ATMPs) in the European Union.