Integrating Quality by Design Principles into Gene-Therapy CMC Programs: Establishing Manufacturing Control and Comparability

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

Programming the immunological properties of mRNA vaccines for cancer

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

MATCH cohort provides regulatory-ready external control framework for MSUD gene therapy trials

This article presents the MSUD Age-matched Standard Treatment Cohort (MATCH), a prospective natural history study of 11 infants with classic

MATCH cohort provides regulatory-ready external control framework for MSUD gene therapy trials

This article presents the MSUD Age-matched Standard Treatment Cohort (MATCH), a prospective natural history study of 11 infants with classic

CovationBio presenta dos nuevas innovaciones de base biológica en la Functional Fabric Fair de Nueva York