CyanVac has partnered with CDMO Exothera to develop and manufacture its intranasal COVID-19 vaccine candidate CVXGA1 using the scale-X platform.
Georgia, US-based vaccine developer, CyanVac has selected contract development manufacturing organization (CDMO) Exothera to advance development of a manufacturing process for its COVID-19 vaccine candidate that is administered intranasally as a single dose to prevent SARS-CoV-2 infection.
“We have been working on intranasal vaccines for over 20 years,” Biao He, CEO and founder of CyanVac told BioProcess Insider. “The viral vector based on parainfluenza virus 5, is a ‘natural born intranasal vector’ which contains PIV5 (commonly known as canine parainfluenza virus in veterinary field), has been administrated to dogs via intranasal route for several decades.”
He continued: “Human respiratory infections start at respiratory tract. We get infected via contact with viruses at respiratory tracts, such as [the] nose. Immunization at the site of virus entry, such as the nose will generate specialized immunity at the site (mucosal immunity) as well as systemic immunity in blood. This is superior to the injection method, which is not known to generate mucosal immunity.”
CVXGA1 will be manufactured at Exothera’s Vega plant, which is located at Univercells’ Jumet campus in Belgium. Belgium-based bioprocess tech firm Univercells launched Exothera in March 2020 to serve the cell and gene therapy space.
“[The] Vega plant features the latest technology and will produce the vaccine for both the EU and US markets,” a spokeswoman for Exothera told us. “Here it’s not a question of facility, but more because we offer expertise via the scale-X platform. In according with this: our facility is designed with dedicated rooms dedicated to the scale-X platform.”
The scale-X carbo system is an automated cell culture system, which is used for expression and concentration of viral drug substance. The technology is suited for cost-effective clinical production and rapid process development.
“The cell distribution throughout the fixed-bed is homogeneous, which provides consistency within and among batches,” said Exothera’s spokeswoman. “It offers a significant increase of the surface and volume ratio compared to conventional technologies: 10 m² growth surface in 1.8 L working volume 30 m² growth surface in 4.2 L working volume.”
According to CyanVac, Exothera aims to produce clinical trial material in 2021 for its Phase III clinical studies.
Preclinical studies have already established that CVXGA1 can prevent infection by SARS-CoV-2 and produce an immune response. The firm is looking to assess the candidate in a Phase I clinical trial in the first half of 2021.