High-potency API Manufacturing

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Turning Today's Concepts into Tomorrow's Medicines™ 

The increasing trend of highly potent active pharmaceutical ingredients (HPAPI) being used in new drug development candidates has created a tremendous demand for high containment development and production capabilities. 

To meet this industry need, Alcami has invested significantly in the enhancement of its US API manufacturing and development campus in Germantown, Wisconsin with expanded state-of-the-art HPAPI development and manufacturing facilities.

State-of-the-art Features and Support
  • Two fully-qualified cGMP suites designed for SafeBridge® Certification
  • Primary containment and engineering controls for nanogram-level containment
  • Dedicated utility and support systems
  • Fully-certified safety, environmental, industrial hygienist, and toxicology staff
  • Full development and QC support
Multiple Levels of Containment
  • Versatile Howorth Air Technology downflow booths
  • Fully enclosed process equipment 
  • Isolator and ChargePoint® technologies 
  • Isolated double-HEPA filtration airflow 
  • Interlocked personnel and materials flow airlocks with misting shower decontamination
Process Capabilities
  • Small molecule chemistry from gram to 10kg batch size 
  • Glass and Hastelloy® C-22 PLC-controlled reactors up to 100L 
  • Distillation, cryogenic, and hydrogenation capabilities
  • Aurora® filter isolation, drying, and packaging
  • Versatile enclosed processing space for expanded portable capabilities

Take a Virtual Tour of our HPAPI Suites


On-Demand Webinar: Approach to HPAPI Suite Design in a Multi-Use Facility 

As new drug candidates become more potent in the search for more effective and targeted therapeutics, there is a growing demand for reliable facilities and organizations with the capacity and capabilities to support. The development and manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPI) in a multi-use facility faces challenges of technical, procedural, and a perception-based nature. Fundamentally, it all starts with the use of the right tool for the job.

This webinar will focus on the risk-based approach to facility and equipment design when faced with the unique challenges of being a Contract Development and Manufacturing Organization (CDMO):

  • User requirement specification development
  • Containment strategy risk assessment
  • Process hazard analysis
  • Flexible and expandable design
  • Validation strategy
  • Product changeover

Download Webinar Here

On-Demand Webinar: Balancing HPAPI Control with the Chemistry and Efficiency Needs of a CDMO

Effective high containment API manufacturing has certain expectations and requirements; similarly, being a successful contract development and manufacturing organization (CDMO) has its own distinct challenges. When the demands of these two worlds meet, the ability to balance both offers a unique challenge.

This webinar will discuss some practical challenges and resolutions for high containment manufacturing in the CDMO world with diverse chemistry needs and high throughput demands, in particular:

  • Specialized chemistry implementation
  • Integrated risk assessments
  • Management of change
  • Facility design

Download Webinar Here


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