US FDA Pressing Industry To Use Standards For Cell and Gene Therapies
A US FDA official is exhorting the biopharmaceutical industry to adopt standards to help in developing new cell and gene therapy products, yet this may pose difficulties as there is a lack of standards in this space, particularly in areas such as cell viability, chain of identity and viral vector gene quantification.
You may also be interested in...
Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.
Fresh Or Frozen? Orchard Aims For Cryopreserved Gene Therapy Approvals Using Pivotal Trials With Fresh Cell Formulations
Orchard aims to submit three ex vivo autologous gene therapies for approval by the end of 2021, helped by a new regenerative medicine advanced therapy designation (for a rare primary immunodeficiency syndrome) and a breakthrough therapy designation (for another rare primary immunodeficiency).
Argentina’s drug regulator has become the newest member of the International Pharmaceutical Regulators Programme.