Flexible API clinical trial material development and cGMP assets to support your chemical synthesis
We provide clinical trial material for feasibility studies and early & late-phase clinical trials.
World-leading clinical facilities
Our small-scale and launch-scale facilities includes:
- R&D & kilo-labs
- Visp (CH)
- Nansha (CN) - 20-50L vessels
- Specialized HPAPI R&D labs
Small-scale plants are also available that offer API support for early trials and low-volume production. These plants are especially designed for potent compounds, even those at very low levels (down to OEL ≥ 1ng/m3) and for payloads used in Antibody-Drug Conjugates (ADCs).
Clinical trial material labeling and quality requirements
Our R&D pilot plants and small-scale plants adhere to strict global quality standards and facilitate seamless technical transfer into our launch and commercial-scale-facilities. Our QA and regulatory services teams provide all data, information, and support required for the CMC portion of regulatory findings.
| Small-Scale Plant Visp |
Small-Scale Plant Nansha |
Mid-Scale Plant Visp |
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|---|---|---|---|
| Purpose | Campaigns for projects in early clinical phase to low volume commercial API/Intermediates production | Campaigns for projects in early clinical phase to low volume commercial API/Intermediates production | Campaigns for projects in clinical phase to commercial API/Intermediates and HPAPI production |
| Equipment |
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| Some Special Features |
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| OEL | >1μg/m3 | >10μg/m3 | >100ng/m3 |
| Quality Aspects |
GMP ISO FDA Swissmedic |
GMP ISO |
GMP ISO FDA Swissmedic |
R&D deliverables for API drug development
Our R&D deliverables are based on customer technology, regulatory and development API needs.
We deliver:
- Feasibility studies which include: development of innovative processes and 2nd generation processes (1-3 months)
- Small-scale quantities (10–100 kg, 3–10 chemical steps; APIs) (2-3 months)
- Process development production of launch quantities (100 kg –5 tons), full regulatory support, validated processes (APIs, HPAPIs) (3-6 months)
- Support of direct API technology transfers from clients to our industrial plants (1-3 months)
You’ll get cost-competitive manufacturing on an industrial scale as we optimize chemical processes, utilize advanced PAT and minimize unit operations. All supported by specialized quality control and quality assurance expertise for effective, profitable product launch.
Development and optimization of API chemical processes
We have experience in many types of advanced chemical synthesis techniques and are prepared to adapt and/or optimize your process for the best results. You’ll get access to all the technologies you need for successful chemical development.
Our advanced chemical synthesis technologies include:
| Technology | Example |
|---|---|
| Hazardous and Highly Reactive Chemicals | HCN, ClCN, chlorosulfonyl isocyanate, SOCl2, Cl2 (gas/liquid), ketene, diketene, phosgene (cGMP), CO, acetylene, ethylene |
| Organometallic Reactions | Grignard, organolithium, sodium in liquid NH3, organozinc reactions, Heck reactions, Suzuki cross-couplings |
| Reductions | Catalytic hydrogenation (homogeneous and heterogeneous), metal hydrides (NaBH4, LiAIH4), Raney nickel |
| Oxidations | With ozone (batch and continuous), peroxides, oxygen/air, nitric acid, ammoxidation |
| Reactions Under Special Conditions |
Low-temperature reactions (-90°C) |
| Asymmetric Reactions | Transition metal catalysts (hydrogenation, oxidation, Heck/Aldol), biocatalysts, racemic separation, use of chiral building blocks |