Media partners: GE and Valneva boost for vaccines made using EB66 cell line

By Dan Stanton
08-Nov-2016 - Last updated on 08-Nov-2016 at 14:05 GMT

RELATED TAGS: Cell culture, Ge healthcare

GE Healthcare and Valneva have developed a cell culture media they say
reduced batch variability when producing viruses from the EB66 cell line.

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 a ected the cell culture processes.”

Morgan Norris - GE’s general manager for Upstream and Cell Culture – added the chemically de ned nature of the CDM4Avian media minimises
batch-to-batch variability of the medium and therefore the cell culture process and downstream puri cation.

“Reduced process variability supports enhanced quality-by-design (QbD) manufacturing processes and therefore a higher-quality end product,” he told us.
“This simpli es 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 rms, including a deal with GlaxoSmithKline to develop in uenza
vaccines, and HIV and cancer vaccines with Sano 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 rm 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 Modi ed Vaccinia Ankara (MVA)-based vaccines, measles and oncolytic vaccines.”

Media maker

The media itself is being made at GE Healthcare’s Logan, Utah site, but Norris said there are plans to produce CDM4Avian at the rm’s dry powder
medium manufacturing in Singapore as well.

“During manufacture, raw materials are combined to create a chemically-de ned 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 speci cations from several preferred suppliers based around the world – ensuring crucial security of supply of the raw
materials.”

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RELATED TOPICS: Upstream Processing, Bio-Outsourcing, Cell lines