HPAPI product handling from concept to commercial scale manufacturing

HPAPI product development and manufacturing is a core strength of Lonza. 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 / HPAPI applications.

Highly potent drugs are increasingly prevalent in the drug development pipeline driven by oncology research and more targeted therapies across a number of indications. These drug candidates represent a significant change in the way innovators are using small molecules to deliver new patient therapies. This shift toward the use of HPAPIs has led to a pipeline of more effective medicines, with potentially lower dose requirements and/or fewer side effects. This trend towards HPAPI also presents significant handling challenges for innovators and their development & manufacturing partners.

We provide HPAPI development services across all standard chemical reactions for highly potent applications to 1 ng/m3. With more than 20 years of experience and multiple HPAPI taken from early to late stage development and commercialization. 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 Center of Excellence for HPAPI development and manufacturing in Visp, CH, we have a comprehensive platform in place utilizing a highly skilled team, extensive evaluation and training procedures and state of the art facilities.  

Utilizing this combination of technology, infrastructure and expertise, we provide you with seamless, flexible HPAPI development and manufacturing tailored to your specific needs and resulting in reduced program timelines, complexity and risk.

Asset 1

Complex chemistry toolbox Hazardous waste handling Multi-purpose / monoplant Handling of toxic substances
Biotechnology Integrated facilities Clean-in-place set-up / documentation GMP experience
Backward integration of product groups    Containment In-house design and realization
      High resource pool

We also develop and manufacture ADC payloads at our Visp location, and provide integrated development and manufacturing across antibodies, payloads, linkers and conjugations, and sterile fill-finish.

Dedicated infrastructure for HPAPI

The asset base at our Center of Excellence for HPAPI includes multiple lab-scale, pilot and clinical scale, launch and commercial scale production facilities, thereby providing for seamless development, clinical trial material manufacture and commercialization.

Specialized HPAPI R&D labs and small scale plants are in place support early phase clinical to low volume commercial production of potent compounds (to OEL ≥ 1ng/m3) and ADC payloads. Investment is ongoing to expand HPAPI capacity at all scales and to handle extremely high potent compounds to 1 microgram/m3.

  • R&D and Lab-Scale:  8 production lines (10-50L)
  • Small / 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
  • Change-over procedures
  • Capacity for parallel work streams

And we have a track record you can trust. Our team at Visp has developed and is manufacturing dozens of HPAPI compounds. An extensive 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 programs inclusive of contained particle engineering and specialized drug product development and manufacturing (sterile fill-finish, liquid-filled hard capsules and soft gels).  

Driven by oncology research and more targeted therapies, HPAPI now account for more than 30% of the drug development pipeline.

View our latest webinar

HPAPI requirements for fully-integrated service offerings by M. Janssen and P. Kuenti

Technologies and products