Services

Small Molecule API Manufacturing - Custom API

For over 100 years AbbVie has leveraged it’s scientific and manufacturing expertise to deliver small molecule custom active pharmaceutical ingredients (API). This expertise is located across 2 sites in US and Europe: Campoverde, Italy and North Chicago, Illinois. 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.  This enables the ability to support a range of batch sizes and potencies to meet your API’s specific needs.

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Small Molecule API Development and Optimization

Dedicated technical operations teams and pilot plant development services include:

  • Process optimization and monitoring
  • Troubleshooting/investigations
  • Waste stream characterization
  • Tech transfer support
  • PPQ efforts
  • Raw material supplier evaluation

 

Process development equipment includes:

  • Reactors from 0.5 to 5 Liters
  • 0.5 L high pressure reactor for hydrogenation and carbonylations
  • 0.5 L filter dryer
  • 1 disillation column
  • 2 rotavapor
  • 1 vaccum oven

 

Analytical development services include:

  • Testing of development samples
  • Method validation
  • Cleaning method development and validation
  • Method transfer
  • Microbiological method verification

GMP Manufacturing Capabilities for APIs

  • 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
  • HPAPI manufacturing up to OEB5

Commercial API Manufacturing Experience

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

Chemistries/Reactions

  • Biocatalysts
  • 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

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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Oral Solid Dose

Precision processes and global reach.
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North Chicago, IL, USA

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Campoverde, Italy

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