The EB66 cell line is derived from embryonic stem cells of ducks and is deemed by Valneva to be an alternative to the use of chicken eggs for large scale manufacturing of vaccines.
But to optimise virus production and overcome stability issues when using the cell line, the Lyon, France-headquartered vaccine maker teamed up with GE Healthcare to develop the commercial cell culture medium, HyClone CDM4Avian.
“Previously available biphasic cell culture media did have variability between batches,” Valneva’s VP of business development Frederic Legros told Biopharma-Reporter.com. “This variability was due to the nature of the plant-derived components, which then potentially affected the cell culture processes.”
Morgan Norris - GE’s general manager for Upstream and Cell Culture – added the chemically defined nature of the CDM4Avian media minimises batch-to-batch variability of the medium and therefore the cell culture process and downstream purification.
“Reduced process variability supports enhanced quality-by-design (QbD) manufacturing processes and therefore a higher-quality end product,” he told us. “This simplifies manufacturing documentation and helps with the regulatory submission times.”
Immortalised EB66 cell line
Valneva is using its EB66 cell line in partnerships with a number of Big Biopharma firms, including a deal with GlaxoSmithKline to develop influenza vaccines, and HIV and cancer vaccines with Sanofi Pasteur.
But according to Legros, the use of EB66 as an alternative to chicken eggs is only a recent development.
“Due to some intrinsic characteristics, the use of immortal cell lines such as EB66 was not authorized for the production of live vaccines. Progress made in the characterisation of cell lines and a better understanding of their biology conducted health authorities to revise their position and to allow the use of immortal cells for the production of all human vaccines.”
In Europe, for example, the firm told us the EMA has only recently said it intends to revise guidelines to include the use of immortalised cell lines for live vaccine production.
“Valneva expects these new guidelines to open new untapped markets for the EB66 cell line in Europe and therefore for GE, notably for the production of live vaccines such as Modified Vaccinia Ankara (MVA)-based vaccines, measles and oncolytic vaccines.”
The media itself is being made at GE Healthcare’s Logan, Utah site, but Norris said there are plans to produce CDM4Avian at the firm’s dry powder medium manufacturing in Singapore as well.
“During manufacture, raw materials are combined to create a chemically-defined medium which is animal-derived component-free, serum-free, and hydrolysate free, and is supplied to customers as a single-medium formulation,” he said.
“Raw materials are sourced to specifications from several preferred suppliers based around the world – ensuring crucial security of supply of the raw materials.”