Facing the Challenges in Vaccine Upstream Bioprocessing - 19

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

inherently more complex and are perceived to
pose higher risk. To the question, it is unlikely that
an existing commercial manufacturing process
would shift to a continuous process unless there
was an extremely compelling cost benefit in
doing so. The benefits would have to offset the
cost of process development, establishing a new
process at-scale, process validation, and potentially, new clinical studies. Additionally, significant
facility modifications would likely be needed
to convert a fed-batch facility to a continuous
facility. For this reason, it is more likely that a fully
continuous process would be developed for a
new product.
Dr. Lacki: A change of a legacy process to a
continuous version will only happen if a second[or] third-generation of a process is being
considered anyway. However, change of the
infrastructure might prove financially prohibitive. A different story is if a company is building a
new facility for the legacy product or for a brandnew API; in that case, continuous operation will
definitely be evaluated as the capital investment
associated with a continuous plant, at least from
19

| GENengnews.com

the equipment-side perspective [and] should
be much lower compared with batch-based
manufacturing.

manufacturing], although I do not know which
approach they will select to implement this
important transition.

Dr. Zydney: I am not aware of any biomanufacturer that is currently looking to replace
an existing batch process with an end-to-end
continuous process. I think it is more likely that a
fully continuous process will be first developed
for a new product that is particularly well-suited
to continuous manufacturing, or potentially for
a biosimilar where the cost reduction would be
particularly attractive.

Mr. Bonham-Carter: No biopharma would
consider changing an existing commercial
manufacturing process, in my view. Some might
consider changes between Phase II and Phase
III, for reasons of capital risk, uncertain market
demand, tighter quality requirements, or manufacturing network management.

Dr. Morbidelli: It is now demonstrated that
continuous processes provide higher quality
and more homogeneous products, which are
beneficial for the patient. This justifies the
strong support that FDA always provided to the
development of these new manufacturing technologies. In addition, these can also lower the
production costs in the broad sense, which will
obviously impact the growing market of biosimilars. This is why all major pharma companies are
looking carefully at developments [in continuous

GEN: What are the financial implications of a truly
continuous biomanufacturing line?
Mr. Bonham-Carter: Estimates range up to >80%
cheaper in capital costs, but perhaps only 20-60%
in cost of goods. Most models are relatively simple
and do not take account of a company's portfolio
of drugs, risks of failure at different phases, quality
requirements for different drugs, and existing
manufacturing and engineering skill-each of
which will impact true cost to the manufacturer.
Dr. Morbidelli: It depends which parts of

http://www.GENengnews.com

Facing the Challenges in Vaccine Upstream Bioprocessing

Table of Contents for the Digital Edition of Facing the Challenges in Vaccine Upstream Bioprocessing