API Solutions

Highly Potent

Asymchem APIs Intermediates Highly Potent

Multi-prong Approach Minimizes Risk

Highly Potent Active Pharmaceutical Ingredients (HPAPIs or HPAIs) present many challenges due to the complex handling required for toxic substances. Our dedicated cGMP and non-GMP HPAI compound production sites include specialized facilities for common potent compound as well as specialized classes such as (β-lactams). In addition, we’ve designed our equipment and facilities for maximum flexibility and developed processes to eliminate contamination vectors, such as differential pressure cascades and primary decontamination stations within suites. Rigorous qualification, maintenance of facilities, processing equipment, and continual employee training on best practices ensures compliance to our stringent cGMP and EHS requirements

This multi-pronged approach tackles the complex challenges inherent with HPAI handling and ensuring safety and quality

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 surrogate dust containment testing
  • Isolators and air monitoring
  • Continuous employee training