Joanne S. Eglovitch
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Joanne S. Eglovitch
NIIMBL Issues Roadmaps For Advancing Gene Therapy, Vaccine And Antibody Drug Conjugate Manufacturing
A public/private manufacturing technology partnership has produced three roadmaps to help the biopharmaceutical industry navigate some of the regulatory and analytical hurdles in developing and manufacturing gene therapies, vaccines and antibody-drug conjugates. All three roadmaps cite a knowledge gap in the industry and the need for an adequately trained workforce.
US FDA official advises that to avoid the “brick wall” of BLA rejection, manufacturers should characterize their cell and gene therapy products and develop potency assays as early as possible.
As applications for expedited review of cell and gene therapies soar, it is important for their sponsors to take certain steps to enhance prospects for smooth commercial scale-up, the director of US FDA’s center for biologics suggests.
For short-lived cell and gene therapies that must be given to patients before traditional sterility testing results can be obtained, the question is whether less sensitive rapid tests that can be completed in advance might be a better choice. Should manufacturers demonstrate a lack of viable microorganisms, or is it OK merely to show there aren’t enough of them to produce an “infectious dose”?
Manufacturers need to have robust verification processes in place and actively communicate with their trading partners to handle suspect drugs that are not properly serialized under DSCA, FDA draft guidance document says.