High potency manufacturing is an expanding field with a unique set of challenges. Safety remains a primary concern for those handling cytotoxic drug products, as well as the clinicians and patients down the line. Beyond safety, pharmaceutical companies need to plan ahead for how they will manufacture high potency drugs at scale, distributing the end-products worldwide with secure supply chains in place.

AbbVie Contract Manufacturing’s people, processes and facilities encompass the highest Environmental Health and Safety (EHS) industry practices for handling cytotoxic drug  compounds. With a clear understanding of your compounds occupational exposure band classification and proven expertise, AbbVie can help you achieve the most efficient and sustainable cytotoxic drug manufacturing workflow.

Occupational Exposure Band (OEB) Considerations
 

To minimize risk at every phase, AbbVie Contract Manufacturing first works to comprehensively characterize your compound, determining its occupational exposure band (OEB) hazard rating and implementing any necessary safety steps. With this knowledge, we can help you develop optimal high potency manufacturing processes, clinical trial designs and drug delivery methods. Through core facilities, such as our Sligo, Ireland site, we offer contract manufacturing for cytotoxic drug products with potency classification as low as OEB 5 (<1 μg/m3).

    API COMMERCIAL SCALE POTENTS

  • Containment Technology Throughout the Process
  • Independent and Scale-able Equipment Trains
  • Wetmill Capability
  • Wide Range of Production Scale
  • Hydrogenation Capability

    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
 

Our people, protocol and facilities operate at the forefront of this new wave of pharmaceutical development, uniting all necessary components to manufacture challenging cytotoxic drug formulas. Our high potency manufacturing capabilities include:

  • Scalability — AbbVie Contract Manufacturing efficiently handles high potency drugs, from pilot scale (1 kg to 100 kg) through to clinical trials and large-scale commercial production
  • Specialized facilities — Alongside our services, pharmaceutical companies gain access to world-class high potency manufacturing facilities in both Europe and North America. Our support team is readily on hand in either continent and beyond
  • Customized drug delivery – Smart development of high potency drugs must be matched with smart delivery systems. AbbVie Contract Manufacturing offers a range of optimized drug delivery options, from pre-filled syringes to slow-release capsules, along with extensive solubility and dosage knowledge
  • Competitive service — We understand the importance of speed-to-market when it comes to commercial success. Our team offers accurate advice, meeting deadlines and regulatory guidelines the first time around