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Oral Solid Dose

AbbVie is one of just a few CMOs with high potency API facilities in both North America and Europe. We apply our depth of scientific expertise and exceptional safety and compliance acumen to guide your compound from lab to patient.

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Potent Combination

Your innovation. Our expertise. We can't be beaten.

Manufacturing High Potency Drugs:

The expanding field of high potent drugs presents a unique set of challenges and safety concerns for drug developers, clinicians and patients alike. In addition to ensuring the safe handling of potent compounds throughout API and drug product manufacturing, pharmaceutical companies must also safely scale up production to commercial quantities and maintain supply chain security across all distribution channels.

Our High Potency API Capabilities

  • Scalability — Advancing drugs from pilot to clinic to commercial production.
  • Specialization — World-class high potent experts and manufacturing facilities in Europe and North America.
  • Customized delivery — Innovative drug delivery solutions that enhance the efficacy and appeal of your product.
  • Competitive advantage — A highly responsive team to guide and support you and optimize speed-to-market.

Potent Drug Contract Manufacturing

Overall Capabilities


  • Potency classification down to <1µg/m3
  • Potent active pharmaceutical ingredients (HPAPI)
  • Dedicated hydrogenation suite (4,000 L)
  • Process control temperature (-20 ˚C – 120 ˚C)

Unique Capabilities


 
  • Hot Melt Extrusion
  • Single pot processing
  • Split butterfly valve transfers
  • Identical process train configuration to facilitate scale-up activities

Occupational Exposure Band (OEB) Considerations

At our potent product production facilities, we offer contract manufacturing for potent drug products with potency classification as low as OEB 5 (<1 μg/m3). To minimize your risk, we will first comprehensively characterize your compound, determining its OEB hazard rating and implementing the necessary containment and safety measures throughout each project phase. With a clear understanding of your product’s OEB classification, we can then work with you to develop optimal processes, clinical trial designs and drug delivery methods.

Drug Product Development Scale

  • Gram to Kilogram Processing Scales / DOE Runs
  • Contained Glovebox Technology
  • Computerized Data Collection and Control
  • Pilot Scale Production
  • Roller Compactor

Commercial Scale Potents

  • Potent Fully Contained Dispensing, Processing and material transfers
  • Clean In Place (CIP) systems
  • In-Bin Blending
  • Contained Single Pot Processors
  • Encapsulation Capability
  • High-Speed Compression
  • Potent Coating Capability
  • Roller Compactor

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.

Coming Soon

eBook: Ending Clinical and Commercial Headaches in Biopharma

Recent growth in biopharmaceuticals has solved certain problems while introducing new ones. Our recent eBook helps you steer clear of the pain.