Viral vector-based gene therapies hold immense promise for treating a multitude of diseases. However, their widespread adoption has been hindered by inefficient manufacturing methods and the absence of established standardized processes, resulting in high costs and limited accessibility for patients, according to experts.
Cytiva believes its new Elevecta lines can offer some solutions to these challenges.
“To make gene therapy a realistic option for more patients, we need to be able to standardize its manufacturing,” says Emmanuel Abate, president, genomic medicine, Cytiva. “We’ve gone to the heart of the process by creating viral vector cell lines that will make a big impact to developers of gene therapies.”
The company has created three cell lines for adeno-associated virus (AAV) production. Together, the three lines comprehensively meet the distinct objectives of various therapeutic programs with the ability to transition between cell lines as needs evolve and can be paired with Cytiva’s established cell culture media offering, according to Abate, who described the three new lines:
- A transient cell line that provides speed and flexibility enabling researchers to easily integrate it into their existing workflow. This cell line is paired with a new cell culture medium, HyClone prime expression designed to enhance performance. Both the cell line and corresponding media will be available soon.
- A packaging cell line that eases the screening of genes of interest while enabling efficiencies across clinical stages and assets. This line is available now in selected formulations.
- A producer cell line that stably integrates all four required genes for AAV production; production starts by simply adding an induction agent, no transfection is needed. This line is available now to be customized to each individual therapy.
Using stable cell lines, such as packaging or producer cell lines, can streamline the product manufacturing process by simplifying workflows and extensively reducing raw materials, such as transfection reagent and plasmids. Consequently, stable cell lines can lead to reduced costs and faster market access for viral vector-based gene therapies, explains Abate.
Important quality challenge
Coming soon across all three lines is a genetic modification to reduce encapsidated host cell DNA (hcDNA) through a quality-by-design approach, pointed out Abate. This impurity is a notable concern during production of viral vector-based gene therapies. Unlike other impurities, hcDNA cannot be efficiently removed through downstream processing due to its resistance to DNase treatment, posing a significant challenge not yet addressed by the industry, he explained.
“We now offer end-to-end solutions for viral vector manufacturing,” he says. “With our new cell line offering, our customers can deliver higher quality treatments and significantly improve patient access today as well as meet the increasing demand for viral vector material tomorrow.”
