Supply Chain World - Fall 2017 - 14

PHARMACEUTICALS

The pharmaceutical and biotechnology industry is shifting toward
continuous manufacturing to
speed up production.

BY MAURICIO FUTRAN

Breaking Ground
The concept of continuous manufacturing (CM) is not a new one. However, while other industries have applied newer capabilities associated
with continuous manufacturing, the pharmaceutical industry's traditional "batch" manufacturing remains the norm. This has shifted in
recent years, with agencies and pharmaceutical companies pursuing
technologies to enhance efficiency, reliability, agility and reduce cost.
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Supply Chain World FALL 2017

As an industry professional, it is my
belief that as the pharmaceutical and
biotechnology industry and market
evolve, so should our manufacturing
sites and processes in order to accelerate our ability as manufacturers to meet
customer needs. The need for this shift
in approach was further underscored in
the past two years through recommendations from health care authorities.
In 2015, Janet Woodcock, director of
the U.S. Food & Drug Administration
(FDA) Center for Drug Evaluation &
Research (CDER), urged companies to
get on board with this new process when
she spoke publicly in front of Congress
embracing the values of the pharmaceutical industry implementing continuous
manufacturing technology into their
production lines. This new approach enables much faster production and equally
reliable products - an appealing set of
benefits when it comes to the delivery
of safe medicines to people around the
world in need - through an uninterrupted
process. It can reduce testing-to-release
time of pharmaceutical products from 30
days to a target of 10 days or less.
By incorporating state-of-the-art
continuous production and control technology, companies now have the ability
to produce a high-quality product while
meeting the FDA's challenge to accelerate the delivery of innovative therapies
for patients.
Looking to the future, I believe that we
will see increased investment in continuous manufacturing in pharmaceutical
product development on the R&D side
and potential application in biologics
manufacturing. These activities could
lead to reduced scale-up time and, eventually, shorter time-to-market, which
would be a positive outcome for pharmaceutical manufacturers and patients.
Mauricio Futran is the vice president of advanced
technology for Janssen Supply Chain. Janssen was the
first company in the pharmaceutical industry to convert
from batch to continuous manufacturing.



Table of Contents for the Digital Edition of Supply Chain World - Fall 2017

Contents
Supply Chain World - Fall 2017 - Cover1
Supply Chain World - Fall 2017 - Cover2
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