Locations

Campoverde, Italy

AbbVie's Campoverde facility is located approximately 22 miles (35 kilometers) south of Rome, Italy. The 270,180 m2 facility has end-to-end capabilities for your small molecule product including standard and high potent chemical intermediates and API’s, pharmaceutical oral drug product manufacturing and packaging capabilities.

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The Campoverde API manufacturing operations were designed to be flexible to grow with your late phase clinical and commercial supply needs with typical batch sizes ranging from 50-600 kg. The API team has completed 20+ late-phase/commercial tech transfers since 2012 and are ready to apply their commercialization expertise to ensure success of your product. The drug product operations can support many oral drug product processes as well including wet and dry granulation, tableting, oral liquids, sachet filling and packaging including serialization and aggregation. Our Italian operations team are approved by regulators globally for intermediates, API’s and drug products by more than 60 countries.

Chemical API Manufacturing

The site has two primary trains that can be used independently or in combination depending on your process requirements.  The site can support OEB 4 compounds as it is setup with glove boxes for both powder charging and load out.  

Equipment & Manufacturing Unit Operations

  • Glass lined and Hastelloy reactors up to 12,000 L
  • Filter dryers up to 3,000 L
  • Crystallization with milling technologies
  • Carbonylation
  • Inverting bag and peeler centrifuges
  • Low and high pressure hydrogenation

Development and Tech Transfer

Campoverde has a dedicated technical operations team and lab that has experience with:

Expertise

  • Transfer and optimization of new processes including solvent recycling
  • Process optimization including post-approval changes
  • Process and equipment performance qualification and validations

Small scale Processing

  • Reactors from 0.5 to 5 liters
  • High pressure hydrogenation and carbonylation
  • Filter drying

Analytical Transfer and Validation

  • HPLC & UPLC
  • GC-FID/HS
  • Moisture analysis and KF

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

Oral Solid Dose

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

  • High Shear Granulation
  • Roller Compaction
  • Milling
  • Tablet Compressing
  • Tablet Coating

Packaging

  • Blisters
  • Bottles
  • Sachets / Sticks
  • Syringe Blister Packaging

Oral Liquid

  • Plastic Bottles

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
  • Test method transfer
  • QC release including on-site microbial laboratory
  • Degradation studies
  • Stability studies

Sustainabliity

AbbVie is committed to meeting and exceeding environmental policies upheld around the world.

AbbVie Campoverde has a high focus on environmental sustainability.  Efforts focus on solvent recovery and recycling help limit solvent use.  Additionally, the site has on site wastewater treatment and vent treatment units to ensure a safe environment.  

AbbVie has a network of manufacturing facilities around the world to support 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.