Services

Custom API

For over 100 years, our parent company, AbbVie, has leveraged its scientific and manufacturing expertise to deliver custom active pharmaceutical ingredients (API) at its 180-acre facility in Chicago, Illinois. AbbVie CMO puts that technical experience and facility with complex chemistries to work for you, delivering the same quality and safety to your product as our own.

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The Key Ingredient

Quality. Quantity. Control. Your innovation delivered..

AbbVie’s custom API manfacturing operation can operate multiple chemical processes simultaneously including highly potent drug containment. State-of-the-science quality control labs and skilled team support technical transfer and life cycle management activities to achieve commercial-scale production. When combined with our CMC, QA and regulatory know-how, AbbVie is an API partner like no other.

AbbVie CMO’s API capabilities include:

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Commercial Scale

  • 100–700 kg/batch depending on process complexity
  • Total site annual capacity of ~20–30 metric tons
  • Several 10,000 L – 12,500 L tanks (stainless steel and glass lined)
  • Large scale stainless steel and Hastelloy filter dryers
  • Reaction monitoring via OSI-PI software web-based access
  • Multipurpose facility with CAPEX options

Expertise

  • Organometallic (Grignard)
  • Gaseous HCl
  • Acetylene Chemistry
  • Friedel-Crafts Chemistry
  • Cyanation
  • Hydride
  • DIBAL reductions
  • Chlorinated Solvents
  • Chromatography

Process Analytical Technologies (PATs)

  • Mass spectrum analysis for distillations and drying profiling
  • FTIR for reaction completion
  • FBRM/PVM for crystallization
  • Raman for drying endpoint
  • Online particle size measurement 
  • Conductivity for phase separations
  • Refractive index for cake wash solvent displacement

Analytical and Microbiological Testing

  • HPLC (reverse/normal phase and ion exchange, with UV/Vis, RI, fluorescence, ECD and ELS detection)
  • 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
  • Dissolution USP Apparatus 1, 2 and 3
  • 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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