API Solutions

Highly Potent

Asymchem APIs Intermediates Highly Potent

Multi-prong Approach Minimizes Risk

Highly Potent Active Pharmaceutical Ingredients (HPAPIs or HPAIs) compounds present many challenges due to the complex handling required for toxic substances. Our dedicated HPAI compound production facilities in both GMP and non-GMP configurations include specialized facilities for common potent compound classes (β-lactam). In addition, we’ve designed our equipment placement for maximum flexibility and developed processes to eliminate contamination vectors, such as pressurization. We’ve also included primary decontamination stations within suites, ensured the qualification of facilities and processing equipment, and continually train employees on best practices.

This multi-pronged approach tackles the complex challenges inherent with HPAI compounds and delivers a consistent result.

HPAI Capabilities

  • Medicinal chemistry
  • API manufacturing
  • Drug product manufacturing
  • Analytical development
  • Handling compounds with an occupational exposure limit (OEL) of less than 0.1 ug/m3

HPAI Process Assurance

  • Equipment placement is designed for maximum flexibility
  • Synthesis reactors with different specifications: 10L, 50L, 200L
  • Different levels of the production area with air purification system
  • Ongoing facility performance monitoring, including dust testing of
  • Isolators and air monitoring
  • Continuous employee training