small molecules
biologics
cell & gene
bioscience
capsules
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.