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.

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

 

Manufacturing High Potency Drugs
 

AbbVie is one of few CMOs with high potent facilities in both North America and Europe. We apply our depth of scientific expertise and exceptional safety and compliance record to protect your compound from lab to patient. With experienced people, proven processes and world-class facilities, we adhere to the highest regulatory and Environmental Health and Safety (EHS) standards for handling potent drug compounds. 

  • Scalability — Efficiently advance your high potent drug from pilot scale (1 kg to 100 kg) through clinical phases to commercial production. 
  • Specialized facilities — Gain access to our world-class high potent manufacturing facilities in Europe and North America, and gain dedicated support from our expert teams.
  • Customized drug delivery – Choose from a range of innovative drug delivery solutions, to enhance the efficacy and appeal of your product. 
  • Competitive service — We understand the importance of speed-to-market to your commercial success. Our highly responsive team provides you with personalized guidance and support, meeting deadlines and regulatory guidelines the first time around.