Facing the Challenges in Vaccine Upstream Bioprocessing - 7

Facing the Challenges in Vaccine Upstream Bioprocessing * Interview: Vaccine Manufacturing

Mr. Khambati: In scaleup, usually manufacturing
equipment like a bioreactor increases in size vertically while in scaleout the manufacturing suites
increase horizontally. Due to constraints
in a build area it is always better to scale up
than scale out. In regard to the regulatory and
operational framework, it is better to have less
variability in a process and hence scaleup would
be the preferred strategy over scaleout.
Dr. Lovrecz: Scaleout is more important;
however, continuous systems and potentially
further genetic-engineering manipulations still
offer an adequate solution, i.e., we might not have
a need for larger single batch volumes after all.
GEN: If you could hand in a wishlist, which
improvements in upstream bioprocessing equipment for vaccine process development
and production would you like to see?
Mr. Khambati: There are few companies that
are manufacturing disposable perfusion systems.
I would prefer disposable perfusion bioreactors
and continuous purification systems with prefilled
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resin columns rather than traditional stainlesssteel or glass vessels being used in production,
as well as in process development. Single-use
pump heads, media preparation and storage
vessels, sensors, genderless connections, etc.
would also be a part of my wishlist.
Dr. Lovrecz: Enhanced biological efficacy
(so volumes could be kept low), single-use
systems for suspension cells, and improved
cell/cell debris removal.
GEN: Do you expect certain cell lines or organisms
to lose or gain importance for vaccine production?
How important are microbial platforms?
Mr. Khambati: Scientist are studying many
unique life forms to harness their potential
for use for human health improvement. But microbial platforms are always going to be
in demand for vaccine production due to their
unique advantages. The enormous database
and ease of working with microbes make
them preferred choices for most vaccine manufacturing companies.

Dr. Lovrecz: I believe that mammalian cell lines
will dominate for another 5-10 years but, potentially, insect lines and yeast systems may gain
equal importance.
GEN: For some vaccines, like seasonal flu vaccines,
enormous numbers of doses are needed. Which
possibilities for the improvement of biomanufacturing do you think will better fulfill these
demands and avoid shortages?
Mr. Khambati: With the rise in the number of cases
of seasonal ailments like flu, the demand for its
treatment is always going to increase. The only way
the vaccine industry can fulfill this huge demand
is by increasing its manufacturing capacities,
improving titers, and harnessing the unlimited
potential of continuous manufacturing methods.
Dr. Lovrecz: Better antigenicity (novel platforms
such as "Molecular Clamp" or vaccinia virus-based
production) and greater yields (culturing conditions/cell lines) should be able to improve the
vaccine biomanufacturing process. This might
take 3-5 years before we will see significant results.

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Facing the Challenges in Vaccine Upstream Bioprocessing

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