The Importance Of Raw Materials In Viral Vector Manufacturing

The demand for viral vector manufacturing is increasing exponentially due to the success of in vivo and ex vivo gene therapies in Phase I/II & III clinical trials and the increasing number of novel therapies under development. Nevertheless, manufacturing of viral vector at scale presents two main challenges that could jeopardize compliance with cGMP regulations: (i) the sourcing of raw materials and (ii) the management of the supply chain. Having unlimited access to high quality raw and starting materials, such as transfection reagent, cell lines, media components, growth factors, serum, consumables and excipients is crucial. Therefore, it is extremely important to confirm the identity, purity, and quality of raw materials prior to starting the viral vector manufacturing, to guarantee the efficacy of viral vectors and to ensure batch to batch reproducibility. This will also ensure patient safety is considered and safeguarded from the start of the manufacturing process.