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 APIs and drugs are increasingly prevalent in the drug development pipeline driven by oncology research and more targeted therapies across a number of indications. These high potency 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 manufacturing also presents significant handling challenges for innovators and their development & manufacturing partners.
We provide development services for highly potent API across all standard chemical reactions for highly potent applications to 1 ng/m3. With more than 20 years of experience in high potency drug handling 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 for optimized HPAPI development and scale-up.
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.
|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.