Speciality Chemicals Magazine October_November 2018

Lonza Pharma & Biotech:
solving the API supply shortfall
As an insecure supply chain for early intermediates threatens API
production, Sean Diver, director of business development at Lonza
Pharma & Biotech, tells Speciality Chemicals Magazine about the
company’s new initiative to fill the gap.
The topic of pharmaceutical supply
chain security is not a new one for
the industry, but it has long been
focused on the cGMP portion of
the supply chain. However, the
conversation has recently expanded
to include the API precursors –
specifically the supply of non-cGMP
materials – or ‘early intermediates’–
for API production.
Over the last few decades, raw
materials and intermediates for API
supply chains have been mostly
dominated by producers based in
India and China. There have been a
number of instances of supply and/
or quality issues in recent years that
is calling these supply chains into
question. Today, pharmaceutical
companies’ concerns over security
of supply and quality of ingredients
from Eastern producers is leading
them to seek new suppliers of early
intermediates – including from
suppliers based in the West.
Shifting towards cGMP
How did we get to this point?
Starting in the late 1990s, global
chemical capacity expanded
dramatically, leading most
production of non-cGMP materials
to companies in India and China,
while Western producers largely
focused on downstream cGMP
manufacturing. In the next decade,
suppliers in India also shifted their
focus toward cGMP manufacturing,
leaving supply chains for non-cGMP
materials even more dependent on
suppliers from China. The value
downstream manufacturers gained
from this arrangement was driven
by attractive prices.
But over the last few years, the
supply security of non-cGMP
materials has changed significantly.
Many manufacturing facilities have
closed due to poor environmental
conditions and, as supply security
decreases, prices have risen. As a
result, some customers have found
themselves with no qualified source
of non-cGMP materials. Also,
over-reliance on a small number of
producers can contribute to supply
shortages – for example, when a
Chinese API manufacturer’s facility
exploded in October 2016, a global
shortage of an antibiotic drug
occurred, because that site was the
sole source of the drug.
Improving supply chain values
Lonza Pharma & Biotech is well
positioned to address this growing
supply and quality concern with the
launch of its ‘early intermediates’
offer. Early intermediates supply
reflects a century-long legacy
of chemical synthesis at Visp,
Switzerland and over four decades
of experience producing APIs
and their ISO level and cGMP
intermediates. This offer leverages
an internal initiative in that the
company has steadily shifted the
production of both ISO level and
cGMP intermediates in-house at its
extensive chemical production facility
in Visp. This facility provides more
than 600m 3 of chemical capacity
for the supply non-cGMP, ISOcertified
early intermediates to
companies under customised
agreements to improve the value
of their supply chains.
As global API supply chains
continue to evolve and producers
seek new beneficial arrangements
with suppliers, Lonza Pharma &
Biotech is dedicated to producing
early intermediates and APIs to
ensure uninterrupted supply of lifesaving
medicines and encourage
innovation in bringing new
medicines to market. £
Visit Lonza Pharma & Biotech at
CPhI Worldwide, Hall 3, Stand 3F30
www.specchemonline.com