We understand that simply having some reactors in high containment is not enough to manage the modern requirements for manufacturing HPAPI and intermediates. At our development and manufacturing sites in Visp (CH) and Nansha (CN) we have comprehensive platforms in place utilizing highly skilled teams, extensive evaluation and training procedures and state of the art facilities for optimized HPAPI development and scale-up.
HPAPI product development and manufacturing is a core strength for us. We have an excellent track record and industry-leading capacity for HPAPI manufacturing with complementary strengths in contained particle engineering and specialized dosage forms for low dose and HPAPI applications.
Specialized HPAPI R&D labs and small scale plants are in place to support early phase clinical to low volume commercial production of potent compounds (down to OEL ≥ 1ng/m3) and ADC payloads. Investment continues to expand HPAPI capacity at all scales and to handle extremely high potent compounds down to 1 microgram/m3.
This asset base is key for effective process implementation incorporating:
Our teams in Visp and Nansha have developed and are manufacturing more than 50 HPAPI compounds for commercialized drug products. An extensive global inspection record also exists with major regulatory agencies around the world, including FDA, ANVISA (Brazil), Swissmedic, KFDA (Korea), and Taiwan FDA.
We can also provide integrated services options for HPAPI drug handling programs inclusive of contained particle engineering and specialized drug product development and manufacturing (sterile fill-finish and solid dosing options).
Driven by oncology research and more targeted therapies, HPAPI now accounts for more than 30% of the drug development pipeline.
Having worked extensively with the Lonza Nansha site, I’ve found the Chemical Development, QC and Manufacturing teams are thorough, technically excellent, and work well together as a team. The respective personnel think deeply about any problems that may arise.
-Raymond Dagger, Ph.D., President and Principal Consultant, Stonehenge Consulting