News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. The guidance documents address product development and clinical trial design in general, as well as for specific disease indications.
Several key changes that will impact developers of gene therapies are summarized in this note. Read it to learn more!
The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials, process intermediates, drug substance and drug products. This document will discuss the...
Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with scaling your viral vector.
For more product information visit MilliporeSigma - Gene Therapy.