Speciality Chemicals Magazine October_November 2018

our ‘Transform’ strategy, we have
developed a worldwide network
of chemical manufacturing cGMP
sites with diverse capabilities. With
the acquisition of BASF Custom
Synthesis and part of its API
business, we can now offer expertise
in hydrogenation, azide chemistry,
phosgenation, high pressure
reactions and the handling of
halogens (Cl/Br/I). In addition, we
have high containment capabilities
with complex bridging technologies,
including spray drying. Spray-dried
dispersion (SDD) of an API brings
benefits including greater control
over particle size and enhanced
bioavailability. Our drug product
manufacturing sites in Irvine and
Hameln have the latest technology
for aseptic filling processes.
Embracing and integrating new
technologies across our drug
substance and drug product
sectors further supports our
mission to be a world-class service
partner for development and
manufacture, improving the
quality of life for patients. We are
proud of our close work with
clients to optimise their chemical
processes and formulations through
innovative technology.
What do the recent expansions
mean for Siegfried’s clients?
Our spray drying capabilities
have recently been expanded,
advancing Siegfried into a marketleading
position. We are also
expanding our manufacturing site
at our headquarters in Zofingen,
Switzerland with the addition of
40 new laboratory workstations,
enhancing our analytical
capabilities and supporting our
CDMO network activities. Finally,
we have added a qualified prefilled
syringe (PFS) line at our site in
Irvine and a qualified vial line at our
site in Hameln. In addition, a new
ophthalmic line will be implemented
in Irvine. These allow us to comply
with the specific requirements
for the manufacture of biologics
and parenteral dosage forms
including ophthalmics. What these
expansions mean for our customers
is that we are able to target the
leading-edge design space of
pharmaceutical formulations and
can produce existing commercial
product more effectively.
How do you maintain
regulatory compliance across
your global network?
At Siegfried, we aim to have the
same Swiss quality running through
the core of all our worldwide sites.
One outcome of our ‘Transform’
strategy has been the addition to
our global network of a versatile
manufacturing facility in Nantong,
China, which became operational
in 2015. The Nantong facility is
an important contributor to our
fully integrated services, increasing
value for clients by offering lower
cost options throughout an API life
cycle, from pre- to post-patent.
Compliance is a top priority and
adherence to the most rigorous
requirements and quality guidelines
ensures our outstanding track
record with both regulatory
authorities and customers. The
Nantong facility meets all the
requisite compliance requirements
of the Chinese CFDA, the EMEA
and US FDA (site inspection
expected in 2019). The site also
includes a thermal oxidiser and
waste water treatment facility,
allowing us to meet exceptional
safety and environmental standards.
What does the future
hold for Siegfried?
With our extensive investments
in pilot and commercial
pharmaceutical spray-drying, as
well as lab scale development
equipment, we are well equipped to
guide our clients through all stages
of product life cycle from early
development to commercialisation.
With our ‘Evolve’ strategy, we
are focusing on technology and
finished dosage forms to ensure
that we stay at the forefront of
developments in the industry and
expand our global drug product
footprint. We plan to further
enhance our technology base in
bridging technologies such as
micronisation, lyophilisation and
spray drying, as well as adding
new skill sets to our global network
of production facilities. Through
backward integration and by
reaching critical size in the drug
product sector, we plan to add
even more value for our clients. We
are excited about these ongoing
developments and, as a result of
them, we believe our clients can
always expect more with Siegfried
as their preferred partner. £
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