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New Products, New
Players, New Places
Several major trends were anticipated in Pharma Futurology –
Joined-up Healthcare that are starting to emerge. While each of
these trends can be considered to be progress, they are not
without their attendant issues that place pressure on the global
supply chain network.
Harnessing Biologics
The harnessing of biologic molecules for therapeutic purposes
was one of the most exciting developments of 20th century
medicine. Between 2003 and 2006, biologics represented
24% of new drug approvals.
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The market for biologic
drugs is estimated to be US$26 billion by 2010, including
US$17.9 billion for monoclonal antibodies (mAbs),
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rising
to US$22.2 billion for mAbs by 2014.
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These products are highly complex, susceptible to
contamination and sensitive to their environment. The
manufacturing process for biologics includes many separate,
temperature-controlled stages and is highly technical and
specific for each product. A typical manufacturing cycle will
include fermentation, growth, separation and purification
processes, and validation studies can take up to four months.
Scaling up production from small, lab-based samples to
commercial quantities is no simple matter as small changes to
the manufacturing process can yield products that have
radically different properties. Costs – of active drug
substance, equipment, training and time – are greater than
for traditional products, and therefore any errors or wastage
are also much more expensive. In addition, biologics need
temperature-controlled conditions to keep them stable
during transport and storage, which requires commitment,
support and investment from other stakeholders across the
entire supply chain. Overall, this is a high-cost investment
process that requires consistency, visibility, security and
control across the increasingly global supply chain to ensure
product quality and safety are maintained.
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