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 facilitate an accelerated pathway to market and/or reliable commercial supply
- Second sourcing to better ensure the 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.
A flexible approach to API manufacturing
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.