News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Viral contamination is a risk for all biotechnology products. Recent studies have shown that viral retentive filtration is one of the most robust steps in removing all types of viruses.
In this study, we focused on the initial development process of the retroviral-retentive Viresolve® NFR filter. In order to evaluate the efficacy of the Viresolve® NFR filter for removal of large viruses from AGTC’s AAV vectors, a preliminary viral clearance study was performed.
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.