Challenges and Innovation for Cell and Gene Therapy: Focusing on Drug Product Formulation, Fill-Finish Processes, and Packaging for These Advanced Therapies

Manufacturing and regulatory hurdles threaten cell and gene therapy progress

The article discusses how manufacturing and regulatory challenges are hindering the progress of cell and gene therapies, particularly in can

Review of Genetically Unmodified Cells as Drug Delivery Vehicles

This scientific review article discusses the use of genetically unmodified cells as drug delivery vehicles. It highlights how cell-based dru

How excessive FDA manufacturing requirements are bottlenecking cell and gene therapy companies

The article argues that excessive FDA manufacturing requirements are crippling cell and gene therapy companies, using Grace Therapeutics as

Next-generation immune models: bioinks, 3D bioprinting, and future directions

FDA Draft Guidance Allows Gene Therapy Companies to Leverage Existing Data for Faster Product Approvals

The FDA released a new draft guidance on June 2 titled "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorpo

Extracellular Vesicles as Anti-Aging Therapeutics: Mechanisms, Bioengineering, and Clinical Perspectives

This comprehensive review article systematically examines the anti-aging potential of extracellular vesicles (EVs), focusing on their multif