The Hovione New Jersey site commenced operations in 2002 providing process development and small volume API manufacturing and since then its technologies portfolio has evolved with the addition of highly potent compound handling and particle engineering capabilities. The site was first inspected by the FDA in 2007 and has been regularly inspected since.
The Hovione New Jersey site is expanding its capacity by adding a pilot plant production with reactors up to 3000L, a pharmaceutical spray dryer size 3 and Continuous Drug Product Manufacturing technology featuring direct compression, wet granulation and dry granulation. The new pilot plant production started operations in June 2017, the spray dryer will be online in September 2017 while the continuous drug product manufacturing is available since April 2018. The site will be able to provide an integrated offering from Drug Substance to Drug Product in a single location using the latest technologies.
The site houses a well-qualified and experienced Process Development and Analytical Development teams supporting the areas of Drug Substance and Particle Engineering.
Areas of Focused Expertise
The site boasts strong capabilities and physical assets in the following areas:
- State of the Art Automated Pilot Plant for API Manufacturing Plants (100L to 3000L)
- Highly Potent API handling (down to 1µg/m3 and 0.03µg/m3 OEL)
- Cryogenic (Volume 100L to 2400L, Temperature Range -75 to 150ºC)
- Pharmaceutical Spray Drying (Size 1 and Size 3)
- Hot Melt Extrusion (Pilot Scale 18mm pharma twin screw extruder (co-rotating))
- Milling Technology (wet and dry milling)
For details about production equipment – click here
Operations
- Hovione New Jersey plant operates 24 hours a day 5 days a week.
- Quality Control labs support production 24 hours a day 5 days a week.
Certifications
The site was rewarded with VPP Star Award by the Occupational Safety and Health Administration (OSHA) in 2007 and has successfully maintained this status since.
Hovione New Jersey is certified for the Customs-Trade Partnership Against Terrorism (C-TPAT) by the U.S. Customs and Border Protection (CBP).
