36 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 P h a r mTe c h . c o m
Supply Chain
T
he implementation of single-use systems (SUS) for bio-
pharmaceutical manufacturing as an alternative to or in
combination with traditional stainless-steel equipment
offers advantages such as reduced capital cost, faster facil-
ity construction, and more f lexible and efficient manufacturing (1).
In a fully disposable or hybrid facility, however, because pieces of
equipment (e.g., reactors, transfer tubing, holding vessels) are now
consumables, the supply to the manufacturing facility is more com-
plex. The demand for customized systems and the overall growth of
demand for SUS add to the pressure to improve supply.
Most SUS are currently made in the United States and the Eu-
ropean Union, but suppliers are exploring manufacturing of SUS
components in Asia to serve the region's growing biopharma market
more efficiently. In September 2018, MilliporeSigma announced
its first Mobius single-use manufacturing facility in Wuxi, China
would begin production in 2019 (2), and in November 2018, GE
Healthcare announced a collaboration with Chinese healthcare
technology supplier Wego Pharmaceutical to produce single-use
consumables in Weihai, China using GE's Fortem platform film (3).
Shorter lead times are one potential benefit. Local production could
also reduce the environmental impact of shipping components over
long distances (4).
Pharmaceutical Technology spoke with Andrew Bulpin, head of
Process Solutions at MilliporeSigma; Jeff Carter, strategic project
leader at GE Healthcare Life Sciences; Eric Isberg, director of Life
Sciences at Entegris; and Helene Pora, vice-president of Technical
Communication and Regulatory Strategy at Pall about some of the
issues facing the industry as companies look to SUS for biopharma-
ceutical manufacturing.
Supply Chain Challenges
for Single-Use Systems
Jennifer Markarian
Suppliers address
the complexity of
supplying disposable
components to the global
biopharmaceutical
manufacturing industry.
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