Drug Substance Development

Talented people, smart processes and cutting-edge equipment – we have the perfect formula to meet all your process development and scale-up needs.

Hovione has more than 50 years of experience developing and manufacturing high quality products for the pharmaceutical industry. During that time, we have accumulated considerable expertise in process development and scale-up of complex chemistries.

We actively seek to reinforce our core capabilities through the adoption of the latest technologies and methodologies to ensure an enhanced process understanding. This is best exemplified by the fact that Hovione has not only become a leading adopter of Quality by Design (QbD) and associated systems and tools including Process Analytical Technologies (PAT), but also has direct experience in successful regulatory QbD filings.

The quality and experience of our technical staff together with our commitment to remaining at the forefront of scientific know-how, makes Hovione the ideal partner to successfully navigate your API through to commercial reality. Hovione’s commitment to ensuring smooth and rapid scale up of our APIs, led us to develop Excellent Development and Manufacturing guidelines (EDaM), to ensure that Development and Manufacturing speak one language and have clear expectations of the best pathway to scale up. All that being said, Hovione is about more than just excellent chemistry and advanced equipment. It is our people and culture that truly makes a difference. We bring a genuine passion and commitment to everything we do.

 

Related files

Hovione - Drug Substance.pdf
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PAT chemical processes.pdf
pdf (344.29 KB)
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