Phase-appropriate HPAPI development and optimized scale-up leveraging >30 years of experience
We understand that simply having some reactors in high containment is not enough to manage the modern requirements for manufacturing HPAPI and intermediates. Therefore, our holistic approach to develop and manufacture customer projects across all clinical and commercial phases in our global state-of-the-art sites in Visp (CH) and Nansha (CN) encompasses more.
We have a comprehensive platform in place utilizing highly skilled teams with long-term experience, extensive evaluation and training procedures and well-designed and maintained 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.
Dedicated infrastructure for HPAPI development
Specialized HPAPI R&D labs, kilo labs and small-scale plants are in place to support early phase clinical to low-volume commercial (cGMP) production of potent compounds (down to OEL ≥ 1ng/m3).
This versatile setup is also designed to support linker-toxins and payload development and manufacturing needed in bioconjugates and antibody drug linker (ADC) projects. Investment continues to expand HPAPI capacity at all scales and containment levels, allowing also to handle extremely high potent compounds down to 1 microgram/m3.
- R&D and lab-scale and kilo labs: 8 production lines (10-50L)
- Small and mid-scale: 15 production lines (160-2500L)
- Commercial scale: 3 production lines (4000-10000L)
This asset base is key for effective process implementation, incorporating:
- Chemical synthesis and advanced synthesis
- Technological fit
- Large range of different scales to accommodate all types of process in the most optimized setup
- Well established and inspected cleaning and change-over procedures
- Capacity for parallel work streams
A track record you can trust
During the past 15 years, our teams in Visp (CH) and Nansha (CN) have developed and are manufacturing more than 50 HPAPI compounds across the project lifecycle. Many of these compounds are manufacturing to support the supply of approved and commercialized life-saving drug products.
Our extensive global inspection record that exists with major regulatory agencies around the world, including FDA, ANVISA (Brazil), Swissmedic, KFDA (Korea), and Taiwan FDA underpins our capabilities in integrated CMC project management.
We can also provide enhanced services options for HPAPI drug handling programs, inclusive of contained particle engineering and specialized drug product development and manufacturing.
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