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Brochure

Highly Potent Active Pharmaceutical Ingredients (HPAPIs)

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Unparalleled Efficiency and Precision in HPAPI Development and Manufacturing.
At Aragen, we combine our extensive experience and expertise to provide a comprehensive and streamlined process for both HPAPI development and manufacturing, ensuring skilled handling of all aspects of the product life cycle. Our state-of-the-art HPAPI manufacturing facilities offer you an exceptional experience, setting a new standard for quality and efficiency in the industry.

HPAPI facility at Hyderabad
  • Designed to handle highly potent molecules like ADC payloads and linkers with occupational exposure limits (OEL) up to 10 ng/m3
  • In-Process Quality Control (IPQC) isolators for analytical testing
  • Isolators and fume hoods equipped with breach alarms and safety interlocks
  • Personnel entry/exit supported by air shower cabin or water shower chamber
  • Dedicated decontamination facility for equipment, materials, and waste streams
HPAPI facility at Vizag
  • Dedicated manufacturing equipment with isolators and once-through air handling units
  • Comprehensive suite of unit operations designed for safe handling of high-potency compounds including ADC payloads and toxins (up to 10 ng/m3)
  • Contained sampling and dispensing areas equipped with isolators
  • Reactors to handle multiple unit operations, including glass-lined, Hastelloy, Pressure Nutsche Filter (PNF), and Vacuum Tray Dryer (VTD.
  • Reactor capacities ranging from 50–100 L, expandable to 250–500 L
  • Powder processing zones under isolator-based containment
  • Dedicated packaging facility for HPAPI under controlled environment
  • Quality Control (QC) laboratory for HPAPI analytical testing
  • Operator protection through air shower cabin or water shower chamber
  • Deactivation and neutralization facility for effluents and residues
HPAPI facility