Industry-leading clinical and commercial-scale API production services

 

We provide customized product development, cGMP clinical and commercial-scale production services for API and advanced intermediates. Commercial scale API production services are typically provided based on three scenarios:

  • Integrated services from concept or phase I through to commercialization
  • Late-phase clinical transfers often to facilitate an accelerated pathway to market
  • Second sourcing to better ensure security of supply

We maintain a dedicated launch facility for the cGMP production of launch-scale API. Rapid technology transfer into the launch plant from our small-scale plants is facilitated by adherence to strict quality standards at all stages of product  and process development leading API commercial production. 

We focus on flexible supply solutions tailored to your specific needs throughout the development cycle and into commercial-scale supply. Our extensive capabilities and phase-appropriate plants in Visp (CH) and Nansha (CN) facilitate this flexible approach to API manufacturing. Our API commercial production facilities are equipped with state-of-the-art equipment, incorporating years of process optimization, and are supported by multi-purpose plants for starting materials and intermediates.

The flexibility afforded by multi-purpose plants and phase-appropriate processing allows Lonza to meet our customers’ requirements for increasingly complex chemistry, more specialized target product profiles, integrated API and drug product solutions, and accelerated timelines.  

This peer-reviewed publication describes a method for developing intensified and dedicated pharmaceutical processes, known as mini-monoplants. Key value-generating aspects are described at each stage of development, from lab-based development of best-in-class processes to factory-based development for an accelerated time to market and finally to mini-monoplant technology for production at commercial scale.

View the peer-reviewed publication

Mini-Monoplant Technology for Pharmaceutical Manufacturing

Meeting your API commercial production needs through our extensive and flexible capabilities

 

Our launch and large-scale API commercial production facilities in Visp and Nansha provide flexible capabilities in meeting your commercial API requirements:

  • Contained environments (isolation, solids handling)
  • Low-temperature modules
  • Solvent recovery plants
  • Reactor volumes from 160-16000L
  • Low (-90C) to high (650C) temperature reactions
  • High pressure reactions (80 atm)
  • Back-integrated (diketene, ketene, HCN, acetylene)
  • On-site process development services and analytical support

Phase-appropriate assets are in place to support all phases of API development and manufacturing. To achieve robust and efficient process qualification for scale-up, we use modern tools such as in-process sampling and controls, automated workstations, statistical software, and reaction calorimetry.   We focus on cost-competitive manufacturing on an industrial scale by minimizing the number of unit operations of chemical processes and through specialized quality control and quality assurance departments. 

We maintain high containment trains in dedicated HPAPI small-scale to commercial-scale API production facilities at our Visp (CH) site.  

Our plant network operates to stringent global quality standards, and has an excellent regulatory inspection record inclusive of FDA, SwissMedic, MHRA and ANVISA.

Related content

Lonza Expands Highly Potent Drug Product Development and Manufacturing Capabilities
Capability for formulation development has been enhanced with the upgrade of drug product development laboratories for highly potent material handling.
Lonza Nansha, China for Global Excellence in Advanced Chemical Synthesis
Tech brief
The Rise of HPAPI Molecules: Trends in Highly Potent API Manufacturing
Whitepaper
Solid Dosage Manufacturing, Packaging and Distribution
Tech brief