Switzerland Europe
CHEMICAL-SYNTHETIC BIOLOGICS SERVICES in Europe
Development and medium scale cGMP manufacturing including chromatography
About the plant
Development and medium scale cGMP manufacturing including chromatography
Located in the heart of Switzerland, our facility in Aarau is centrally located between Zurich, Basel and Lucerne. The facility opened in 1994 after 4 years of operation at the University of Zurich. We aim to provide a wide range of technology tools such as solid state analysis, chromatography separation, isolation and analytical capabilities.
Activities
- API process research and development
- Small scale commercial API supply
- Chromatography services
Compliance
- ISO
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
- PMDA/MHLW (Japan GMP)
- 9001
- 14001
- 45001
Activity
- CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES, RSM (Raw Starting Materials), Fine Chemicals manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
- Controlled substance: N/A
- BSL: N/A
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), MFDS (South Korea)
Batch Size / Reactor
- Small, Medium, 1 - 10 L, 10-100 L, 100 - 1,000 L
Services
- Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Milling
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