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Flexible cGMP manufacturing
Every resource, at every scale, at every
Hovione facility is designed to ensure that we deliver exactly what you
have asked us to provide precisely at the time you require it.
From lab to commercial production
Hovione provides a choice of multi-site automated
manufacturing facilities and seamless technology transfer between them.
At routine production, Hovione’s manufacturing units focus on product
quality, consistency and performance. However, continuous improvement is
assured by constant liaison with the process chemistry group who participates
in monitoring ongoing industrial production.
Kilo lab and pilot plant simulate Hovione’s industrial plant. All
Hovione facilities meet very high standards of cGMP compliance, anticipating
emerging regulatory requirements. Automated manufacturing processes streamline
production whilst ensuring effective control and safety. Cross-contamination
is avoided by design. Solids are handled in independent isolated loading
bays that meet clean room standards. Final product packing is carried out
in class 100,000 or better clean rooms, suitable for the finishing of injectable
grade APIs.
Engineering integrity and preventive maintenance
In-house engineering staff can order long lead time
manufacturing equipment well before the process chemists have completed
their work. Our own personnel can make plant changes overnight (under strict
change control) so a fast track process can run better the next day.
Technology transfer
Hovione’s New Jersey facility was specifically
designed to address the needs of early stage development. With advanced
cGMP facilities from lab scale to pilot plant, we help customers achieve
an efficient transfer of a development process into our manufacturing environment.
Systems and processes we have put in place:
• Technology transfer standard procedures
• Project management templates
• Relationship building and KAM procedures
• Communication using NavStream™
• Supply chain management – sourcing
building blocks fast or low-cost, as required
• Engineering integrity and preventative
maintenance
Technology that goes beyond traditional API manufacturing
Hovione has a comprehensive range of high quality,
flexible facilities. When necessary, we work closely with the customer to
install new equipment. As a result, Hovione’s current manufacturing
facilities are among the most extensive and up-to-date in the industry.
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About Hovione 
Exclusive API services
