Services

Custom API

For over 100 years AbbVie has leveraged it’s scientific and manufacturing expertise to deliver custom active pharmaceutical ingredients (API). This expertise is located across 3 sites in US and Europe: Campoverde, Italy; North Chicago, Illinois; and Sligo, Ireland. AbbVie CMO puts that technical expertise and commercialization experience to work for you, delivering the same quality and safety to your API as our own.

 

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Flexibility Enabling Success

AbbVie’s API sites have a range of scales and the flexibility to run multiple chemical processes simultaneously to support late development phase and commercial APIs including highly potent drug containment up to OEB4. This enables the ability to support a range of batch sizes and potencies to meet your API’s specific needs.

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Commercial Experience

  • 8 commercial APIs
  • 16 intermediates
  • 20 completed tech transfers
  • Approved to supply in more than 60 countries

Chemistries/Reactions

  • Organometallic (Grignard)
  • Gaseous HCl
  • Acetylene Chemistry
  • Friedel-Crafts Chemistry
  • Cyanation
  • Carbonylation
  • Heterogeneous/homogenous catalytic reactions
  • Hydride
  • DIBAL reductions
  • Chlorinated Solvents
  • Hydrogenation (low + high pressure)
  • O2 sensitive
  • Coupling,  protection/deprotection reactions

Manufacturing Capabilities

  • High potent API (HPAPI) up to OEB4
  • Hastelloy and glass lined reactors ranging from 1,000 L to 12,000 L
  • Low and high pressure hydrogenation
  • Carbonylation up to 6 bar
  • Crystallization
  • Inverting bag centrifuges
  • Peeler centrifuges
  • Filter, agitated, tumble and fluid bed drying
  • COMIL and Pin milling
  • Chromatography

Process Evaluation and Optimization

Dedicated technical operations teams and lab scale process equipment supports development work including:

  • Transfer of new process
  • Process optimization
  • Troubleshooting/investigations
  • Waste stream characterization
  • PPQ efforts
  • Raw material supplier evaluation

Analytical Testing

Full support for method validation, method transfer, incoming raw material testing, in-process and final release testing. Analytical methods include:

  • HPLC (reverse/normal phase and ion exchange, with UV/Vis, RI, fluorescence, ECD and ELS detection)
  • UPLC
  • GC (direct injection and headspace analysis with FID and TCD detection)
  • ICP-OES, ICP-MS, GC-MS and LC-MS
  • Spectroscopy (FT-IR, UV/Vis and AA)
  • Powder X-Ray Diffraction, DSC Optical Electron Microscopy Surface Area and Particle Size Analysis
  • Moisture analysis (KF and water activity)
  • Cleaning Methods (LC and TOC)
  • Microbiology Testing
  • ICH Stability Storage and Testing

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.

 

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