Facing the Challenges in Vaccine Upstream Bioprocessing - 21

Facing the Challenges in Vaccine Upstream Bioprocessing * Integrated Continuous Manufacturing of Biologics: Trends in the Field

keeps increasing) and to the expectation from
society to make these medicines affordable for all.
Personally, I don't think the [biologics] industry
will ever approach the commodity industry where
every tenth of a cent counts-but it will definitely
aspire to lower the manufacturing costs, to deliver
affordable medicines, and to stay competitive
against its peers. The patent cliff is here to stay.
Mr. Zijlstra: Many large pharma companies
are actively testing intensified and continuous
approaches in their advanced research and
development labs. Intensified technologies are
being implemented as we speak. However, before
the fully continuous technology is accepted by
manufacturing as a replacement for the existing,
proven, and robust platforms, there is still some
technological and regulatory strategy development required.
Dr. Najera: I think it is related to a struggle within
the industry to be able to define a single batch or
a lot of drug product from a regulatory perspective. A drug product is not complete without
the associated paperwork that describes the
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processing (e.g., batch records, analytical results).
Continuous manufacturing really challenges us
to rethink how to present this paperwork to sufficiently demonstrate how the purification process
to make that drug is under control. For example,
a continuous process may rely on time-based
process analytical data showing that the product
quality is well controlled, rather than analytical
results for intermediates at specified points in the
process. In sum, although the regulatory agencies have encouraged the introduction of more
continuous processes, a strategy for how to define
a continuous batch' it not straightforward.
Mr. Gach: The 'continuous' market is in a stage
like when single-use was first introduced-it
was adopted in the areas where [it would have]
the highest benefit or were the most developed
areas, and only recently has grown into a full-on
production scenario. Presently, leading companies are actively applying continuous technology
in unit operations where they are feeling the
most pain and the technology is straightforward.
With these experiences, they will gain confidence
and (regulatory) buy-in to expand further up- or

downstream. Some will eventually grow into
full continuous, while others will gain significant
benefit using 'continuous' technologies to debottleneck batch operations.
Dr. Zydney: Biomanufacturing tends be conservative' in its approach-the primary goal is to
provide a manufacturing environment that is
capable of delivering the desired biotherapeutic
in a fully robust fashion, while satisfying all safety
and regulatory requirements. Fully continuous
biomanufacturing is currently untested'; there
is inherently greater uncertainty regarding the
manufacturing process, including the approval of
that process by the appropriate regulatory agencies. Many biopharmaceutical manufacturers
would be happy to be second' in the development of a continuous process, but they are very
reluctant to be first. Some of this is cultural/
organizational-the individuals involved in the
development of new technology solutions that
will be needed in continuous bioprocessing may
not be the people making the final decision on
the design of the manufacturing facility. However,
considerable progress is being made, both by

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Facing the Challenges in Vaccine Upstream Bioprocessing

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