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| | Sites and
cGMP facilities
Hovione has more than 530m3 of flexible
production capacity with vessels ranging in size from 20 to
16,000 liters.
Flexible cGMP manufacturing
capacity
Hovione has more than 530 cubic meters of production capacity
in three FDA inspected sites: Portugal (Loures), China (Macau)
and the USA (East Windsor, New Jersey). Five decades of focus
in research and manufacturing activities in APIs explain the
depth and breadth of available expertises, capabilities and
experience.
We are dedicated to the manufacture of pharmaceutical fine chemicals
complying with cGMP and regulatory filings. 95% of our sales
are final APIs.
We are specialists in pharmaceutical chemistry and see ourselves
as generalists in fine chemicals. Whatever the project requires
– if it fits our strategy – we will perform every
chemistry, make available any condition and will implement whatever
engineering solution the process requires.
Our facilities suit every scale across our offering
– from phase I to compliant routine manufacture –
and are constantly being adapted to suit projects.
Robust and mature procedures regulate the finer points of our
activities:
– Phase appropriate GMP standards
– Policy on IP use and ownership, and patent assignment
– Tech transfer from customer to Hovione, from R&D
to a validated routine production environment and from site
to site.
– Project management follows a defined template
Global production facilities:
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Materials
of construction range from glass lined, halar coated,
TeflonTM, MonelTM, HastelloyTM and various types of stainless
steel |
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Qualified
clean rooms are used whenever solids or wet cakes are
handled n Class 100,000 or better clean rooms for all
finished product packing n State-of-the-art cGMP spray
drying facilities, including large scale injectable grade
capabilities and small volume sterile API |
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High potency
category 3 compounds manufacturing facilities |
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Multiple vessel
reactor trains operating at -90°C address process
needs |
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High pressure
hydrogenations to 100 bar, including a Buss loop reactor |
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Routine handling
of HF at large-scale |
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DCS automated
plants and electronic batch records in operation for over
10 years |
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24/7 piloting
and manufacturing, with QC support |
Investment in advanced technologies
Hovione’s commitment to modern and well-maintained equipment
and new technologies has always been apparent to any visitor
to our sites. Every year significant capital expenditure ensures
that our GMP is current and our technologies state-of-the-art.
Ask us about our use of PAT to define “design space”
and how it is used in our labs and in our validated production
lines. Come and find out how our Particle Design technologies
can help improve the bioavailability or the stability of your
drug product.
Highly qualified and well-trained
people
Reliability and consistency are the
result of well trained and motivated staff. At Hovione, we make
sure this is routine, not a matter of luck.
Nothing we have achieved would have been possible without our
people. Auditors routinely report that they find our staff technically
proficient and enthusiastic. Employee turnover is less than
4% per year.
We are committed to the professional development of our staff
at all levels and invest accordingly. Employees across all geographic
locations are united by a common approach to projects. Our "one
company, multiple locations" culture has three distinctive
attributes: process chemistry skills within an industrial environment,
a pharmaceutical culture and a rigorous quality mind-set.
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About Hovione 
History of Hovione
Sites and cGMP facilities 
