Flexible Manufacturing to Meet Every Stage of Product Development
At our Visp site, we provide customized 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. Integrated facilities ensure rapid scale-up and commercialization of drug substances.
|Small scale plant
||16 reactors (up to 250L)
|Launch / mid-scale plant
||57 multi-purpose reactors (250–3000L)
||6 multi-purpose reactors (10000L)
||6 reactors (10000L)
||10 reactors (600L)
|Continuous flow manufacturing
Our API 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.
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 QC/QA approaches.
The extensive capabilities and phase-appropriate plant network at Visp are augmented with our Nansha (CN) site, providing increased flexibility in meeting your program’s specific needs. Our manufacturing sites adhere to stringent global quality standards, with the Visp site having an excellent regulatory inspection record inclusive of FDA, SwissMedic, MHRA, ANVISA (Brazil), KFDA (Korea) and Taiwan FDA.
Specialized Capabilities / Highly Potent API Development and Manufacturing
Our launch and large-scale production facilities at Visp provide specialized capabilities and expertise across a full range of chemical synthesis.
- 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
The Visp site also serves as our Center of Excellence for HPAPI development and manufacturing, with dedicated HPAPI small-scale to commercial-scale production facilities and high containment trains in place.
Specialized HPAPI R&D labs and small scale plant are in place support early phase clinical to low volume commercial production of potent compounds (to OEL ≥ 1ng/m3) and ADC payloads. Investment is ongoing 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)
||3 production lines (4000–10000L))
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. Contained particle engineering and specialized drug product development and manufacturing for low dose / HPAPI applications (sterile fill/finish, liquid-filled hard capsule and soft gels) are also available within our plant network.