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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.


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

Dedicated infrastructure for HPAPI Development

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 to support early phase clinical to low volume commercial production of potent compounds (to OEL ≥ 1ng/m3) and ADC payloads. Investment continues 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

Experienced HPAPI Partners

And we have a track record you can trust. Our team at Visp has developed and is 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 account for more than 30% of the drug development pipeline.

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

technology
Liquid-Filled Hard Capsule Technology
Liquid-filled hard capsule technology has a proven track record in addressing a range of complex formulation challenges inclusive of solubility/bioavailability and low dose/highly potent issues. We provide integrated services for LFHC development and manu...
technology
Soft Gelatin Capsules
Softgels provide an important dosage technology that can be highly beneficial in addressing a wide array of formulation challenges, such as bioavailability enhancement and low dose/HPAPI applications including hormones.
service
Particle Engineering Services
Particle engineering is increasingly required to prepare active pharmaceutical ingredients for effective drug product formulation for oral solid and inhaled applications.
service
Process Definition and Sample Preparation
We have experience with a wide range of platform and novel bioconjugation technologies to support drug discovery activities. We can perform cell line construction/strain development, GMP cell banking, manufacture both your payload and linker and perform t...
service
Process Development and Optimization
We leverage our experience in biopharmaceuticals and small molecules to develop, scale-up and optimize processes for ADCs in support of both clinical and commercial manufacturing processes.
service
Formulation Development
Our Drug Product Services team (Lonza DPS) offers a smart approach that considers the interplay between solubility, local tolerance and systemic toxicity for rapid and successful development of your parenteral small molecule program.
service
ADC Payload Product Development
Lonza offers tailored services to fit your specific ADC development plan. Learn about our expertise in antibodies, payloads, and bioconjugation.
offering
Bioconjugate Services
A complete offering for the development and manufacture of bioconjugates including Antibody-Drug Conjugates, PEGylated proteins, and vaccines. Our end-to-end offering simplifies the value chain by manufacturing all intermediates, drug substance and drug ...
service
Small Molecule Parenteral Formulation Development
Our Drug Product Services team (Lonza DPS) offers a smart approach that considers the interplay between solubility, local tolerance and systemic toxicity for rapid and successful development of your parenteral small molecule program.
service
Analytical Services
We leverage our experience in biopharmaceuticals and small molecules to develop, robust analytical methods for the manufacture of intermediates and conjugated ADC drug substance. Phase appropriate methods are used to support both clinical and commercial m...
service
Small Molecule Parenteral Manufacturing
Our Drug Product Services (Lonza DPS) team manufactures GMP liquid and lyophilized parenteral small molecule drug product batches for clinical and commercial supplies, as well as non-GMP batches for toxicological and stability studies, in addition to refe...
service
Targeting Agent and Carrier Protein
We have extensive experience in expressing, developing and manufacturing recombinant proteins for use as targeting agents or carrier proteins for bioconjugates. Let us simplify your supply chain by manufacturing all intermediates as well as your bioconju...
service
Drug Substance Manufacture
By leveraging our experience in biopharmaceuticals and small molecule drug process development and scale-up, we support manufacture of a variety of bioconjugates including high potency ADCs to support both clinical and commercial supply. We offer a varie...
service
Drug Product Manufacture
Our Drug Product Services team manufactures GMP liquid and lyophilized drug product batches for clinical and commercial supplies, as well as non-GMP batches for toxicological and, stability studies, in addition to reference standards. This encompases a v...