Facing the Challenges in Vaccine Upstream Bioprocessing - 16

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

Ph.D., distinguished professor of chemical engineering, The Pennsylvania State University;
Michelle Najera, Ph.D., downstream development scientist, CMC Biologics; Gerard Gach, chief
marketing officer, LEWA-Nikkiso America; Dana
Pentia, Ph.D., senior application scientist, and
John Bonham-Carter, director of upstream sales
and business development at Repligen; Gerben
Zijlstra, platform marketing manager, continuous
biomanufacturing, Sartorius Stedim Biotech; and
Karol Lacki, Ph.D., vice president of technology
development at Avitide.
Common conclusions from the experts were that
the use of surge tanks in continuous lines has
both benefits and drawbacks (see the Bioprocessing Perspectives column on page 22 in the
September 15 issue of GEN); enzyme-replacement
products and monoclonal antibodies (mAbs) will
likely be the first product candidate types selected
for integrated continuous manufacture (more
specifically, mAb-based biosimilars); and manufacturers are less likely to switch legacy products
from existing batch processes to continuous
operation. The high prices of affinity resins are
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not expected to decline significantly in the near
future, and continuous production could result in
resin cost savings-but the experts explain there
are many benefits of continuous production of
biologics besides those related to cost.
Most of the products that would likely be made
in integrated continuous lines will be new products, and will also primarily be labile biologics or
those which have uncertain demand. Continuous
operation, says Bonham-Carter, will allow engineers to react to fluctuations in product demand
and give companies the option to build late (or
build out) significantly, if required. Dr. Morbidelli
asserts that peptides, fusion proteins, scaffolds
with mAbs, and other products "containing sensitive antennary glycostructures that are needed for
biological activity" would also be types of therapies that could be made in continuous flows.
To tell which pharma manufacturers are likely to
integrate end-to-end continuous manufacture
into production lines first, investors and industry
insiders should follow company patent filings
and peer-review articles authored by company
representatives. As Dr. Zydney points out, manu-

facturers that are already "clearly interested" in
fully continuous biomanufacturing lines include
Genzyme, Merck, Bayer, and Sanofi, among
others. Also doing work in this space: Novo
Nordisk, Novartis, Amgen, Shire, Pfizer, WuXi,
and BiosanaPharma. In addition, some contract
manufacturing organizations (CMOs) are in the
continuous biomanufacturing field (such as CMC
Biologics), and these organizations are poised to
help biopharma clients lower the cost to clinic by
way of fully continuous manufacturing strategies.
Regardless of who is or is not investigating continuous, "What is definitely a right development trend is
that vendors do support the change and offer technologies that enable continuous operations," says Dr.
Lacki of Avitide, a company that makes affinity resins.
"At the end of the day, it will be up to the end user to
decide how a process needs to be operated, but the
choice will be made on a thorough assessment of
commercially available technologies."
GEN: What types of biologic medications are
the best/most feasible candidates for integrated
continuous manufacture?
http://www.GENengnews.com
Facing the Challenges in Vaccine Upstream Bioprocessing

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