Catalent introduces new AAV gene therapy tech in aim to speed up manufacturing process
As Catalent ventures further into the world of cell and gene therapy manufacturing, the New Jersey-based CDMO has revealed its new adeno-associated viral vector platform.
The UpTempo Virtuoso platform can streamline the AAV manufacturing process to cut back on the time it takes to go from clinic to in-human clinical trials. It includes protocols for cell culture, transfection, and downstream purification, and can simplify the critical supply chain. It’s designed to produce products for the clinic in just nine months, Catalent says, and customers will have access to Catalent’s plasmid DNA offerings, too.
In a statement, C> President Manja Boerman said:
“As one of the first CDMOs to successfully develop a suspension-based transient transfection process, and our deep and specialized viral expertise and broad experience across more than 70 viral vector programs, we have built this new process with the goal of providing our customers with a reliable, reproducible, and scalable path to clinic. As the gene therapy pipeline expands to a broader disease portfolio, and in anticipation of rising regulatory requirements, our optimized and standardized CGMP manufacturing process is designed to meet robust CMC submissions for AAV gene therapy products, while providing customers with the advantage of shortened timelines.”
The platform will be featured at its Maryland-based network in Baltimore and Gaithersburg, as well as commercial scale manufacturing at BWI Airport. pDNA production is carried out in Rockville, MD and Gosselies, Belgium.
At the end of May, Catalent expanded its nasal drug development and manufacturing operations in Morrisville, NC. Its doubling down on an expanding into new drug delivery forms, adding onto its acquisition of the gummies maker Bettera in August 2021.