Industry-leading commercial-scale API production services

 

We provide customized product development, cGMP clinical and commercial-scale production services for API and their intermediates. Commercial scale 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 development. 

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. These 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 trend towards specialty and patient-centric medicines increasingly demands more complex chemistry and integrated solutions

View the press release

New capacity completes Lonza's range of HPAPI capabilities from development to commercial scale manufacturing, including formulation and delivery

Extensive capabilities to meet your commercial API needs

 

Our launch and large-scale 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 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.

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