Life Science Special Report December 2015

PHARMACEUTICAL CONTINOUS MANUFACTURING LIFE SCIENCES
NUMERICAL SIMULATIONS
FOR CONTINUOUS
MANUFACTURING OF
ACTIVE PHARMACEUTICAL
INGREDIENTS
SABINE GOODWIN, DR. KRISTIAN DEBUS
CD-adapco
FROM BATCH TO CONTINUOUS
PROCESSING
The pharmaceutical industry is
encountering a decline in productivity,
and outdated “tried-and-true” batch
processes are at the root of the problem.
The batch-based systems currently in
place are ineffi cient due to segmented
steps involving multiple facilities and
requiring start-and-stop of the batch,
site-to-site transfer and warehouse
storage. Performed through sampling and
in post-production, quality assessment
of the product is also cumbersome,
causing long lead times and waste.
Continuous manufacturing, a non-stop
end-to-end manufacturing process,
could modernize the industry and solve
its productivity crisis. At a recent MIT
conference, Josef Jimenez, CEO of
Novartis, stated that changing production
from batch to continuous will transform
the way medicines are made around
the world and could cut the time from
development to market-entry in half [1].
Implementation of these processes will
result in smaller production plants, lower
inventory costs, reduction in carbon
footprint and higher quality products [2].
The regulatory agencies are also starting
to lay the groundwork for continuous
manufacturing with several initiatives [3,
4] and regulatory frameworks such as the
Process Analytical Technology (PAT) and
Quality by Design (QbD). Each of these
encourages the development of new
FIGURE 1: Ultra-lean manufacturing,
from start of chemical synthesis to fi nal
pharmaceutical dosage form (courtesy
of Novartis-MIT Center for Continuous
Manufacturing)
manufacturing technologies by building
quality into the process and using a
science-based quantifi ed risk approach.
Both the chemical and food processing
industries have been improving their
productivity by successfully integrating
continuous manufacturing into their
plants. It is clear that regulatory
hurdles and conservative thinking
by the pharmaceutical industry can
no longer be used as an excuse
to avoid taking pharmaceutical
manufacturing into the 21st century.
NUMERICAL SIMULATIONS AND
CONTINUOUS MANUFACTURING
Before continuous manufacturing
can become main-stream, potentially
suitable candidate processes must be
identifi ed and designed, and risks must
SPECIAL REPORT
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