Locations

Campoverde, Italy Contract Manufacturing Capabilities

AbbVie's Campoverde facility is located approximately 22 miles south of Rome, Italy. The 270,180 m2 facility has both chemical API and pharmaceutical drug product capabilities.  Our Italian operations team has received numerous awards for quality products and services and approved by regulators globally for both clinical and commercial drug substances and drug products.  Campoverde’s chemical and pharmaceutical operations serve more than 60 countries.

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AbbVie’s Italy contract drug manufacturing facility is comprised of three integrated divisions – two for active pharmaceutical ingredient (API) manufacturing and one for the formulation and finishing of drug products, including liquid dosage. The Italy facility has specific expertise in a variety of drug formulation processes, including massing, drying, and compressing granulation, as well as bulk API manufacturing. Combined, Campoverde’s chemical and pharmaceutical operations serve more than 60 countries.

This is one of our several AbbVie facilities around the world that supports active pharmaceutical ingredient manufacturing and finishing of drug products.

Chemical API Manufacturing

AbbVie’s Campoverde facility has over 50 years of experience manufacturing  API’s.  The site has two primary trains that can be used independently or in combination depending on your process requirements.  The site can support OEB 3 compounds as it is setup with glove boxes for both powder charging and load out.  Key equipment include:

  • Glass lined reactors up to 6500 L
  • Hastelloy reactors up to 5000 L
  • Agitation tanks
  • 2000 L filter dryer
  • Hydrogenation reactors

Analytical Testing

Campoverde has an on-site analytical laboratory that can support all of your program’s needs.  Key testing capabilities include:

  • Analytical test method development and validation
  • Product and stream characterization
  • Test method transfer
  • Degradation studies
  • Stability testing

Process Development and Validation

Campoverde technical team has developed and validated numerous commercial API processes.  The technical expertise is that site has experience with:

  • Process development including dissolution studies, solvent recovery and design of experiments (DOE)
  • Process characterization/justification to support regulatory filings
  • Process validation
  • Process optimization including post-approval changes

Regulatory and Quality

AbbVie Campoverde maintains a range of regional and global regulatory standards to meet guidelines for your intended markets. The Campoverde site has:

  • Been audited and approved for commercial production by the U.S. FDA and EMA regulatory authorities
  • Earned certification for ISO 9001, ISO 14001, OSHAS 18001 and DUNI 10167, as well as FDA and EMEA compliance. 
  • A new distributed control system (DCS) for batch execution and to automate process steps including solvent charging, temperature control and material transfers to minimize operational errors
  • Electronic batch records to ensure data integrity and in-process control sample management via LIMs.

Oral Drug Products

The Campoverde, Italy facility has specific expertise in a variety of GMP drug product manufacturing processes including granulation, compressing, liquids and packaging. 

AbbVie Italy contract manufacturing capabilities include:

  • Oral Solid Dose
    • High Shear Granulation
    • Spray Granulation (Fluid Bed)
    • Dry Granulation via Roller Compactor
    • Tableting
    • Tablet Coating
  • Packaging
    • Blisters
    • Bottles
    • Sachets / Sticks
  • Oral Liquid
    • Plastic Bottles

Capabilities

AbbVie is committed to meeting and exceeding all environmental policies upheld in Italy and around the world. Manufacturing is performed with sustainable resource practices in all of our facilities.

AbbVie's has a network of manufacturing facilities around the world to support your project and project needs.  See AbbVie's other locations for additional manufacturing site information and technical expertise.  

To discuss how these technologies can benefit your drug development program, contact AbbVie today.

An AbbVie CMO representative is eager to talk to you.

AbbVie CMO is a seasoned partner for all your contract manufacturing needs. Let’s start a conversation today. The future is a click away.