Research Articles
Navigating ATMP Regulatory Requirements in 2025: A Strategic Guide for Developers
This article provides a comprehensive overview of the current regulatory landscape for Advanced Therapy Medicinal Products (ATMPs), targeting researchers and drug development professionals.
GMP in Stem Cell Biomanufacturing: A 2025 Guide to Quality, Scale, and Regulation
This article provides a comprehensive overview of Good Manufacturing Practice (GMP) for researchers, scientists, and drug development professionals working in stem cell biomanufacturing.
Navigating GMP Guidelines for Stem Cell Therapy: A Roadmap for Clinical Translation
This article provides a comprehensive guide to Good Manufacturing Practice (GMP) for researchers and drug development professionals translating stem cell therapies from the lab to the clinic.
Navigating EU and US Cell Therapy Manufacturing: A Risk-Based Approach to Regulatory Controls
This article provides researchers, scientists, and drug development professionals with a comprehensive guide to implementing risk-based controls for cell therapy manufacturing across evolving EU and US regulatory landscapes.
Navigating the Divergence: A Comparative Analysis of EU and UK Cell Therapy Manufacturing Regulations Post-Brexit
This article provides a comprehensive comparative analysis of the evolving cell therapy manufacturing regulatory landscapes in the European Union and the United Kingdom post-Brexit.
ATMP Certification for SMEs: A Strategic Pathway to Streamlined Marketing Authorization
This article provides researchers, scientists, and drug development professionals with a comprehensive guide to navigating the European regulatory landscape for Advanced Therapy Medicinal Products (ATMPs).
Navigating the Maze: A Comparative Guide to EU National Competent Authorities for ATMP Oversight
This article provides a comprehensive comparative analysis of the roles and processes of National Competent Authorities (NCAs) in the European Union for Advanced Therapy Medicinal Product (ATMP) oversight.
Navigating EU Licensing for Autologous vs Allogeneic Cell Therapies: A Strategic Guide for Developers
This article provides a comprehensive guide for researchers, scientists, and drug development professionals on the European Union's regulatory pathways for autologous and allogeneic cell therapies.
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.