CARBOGEN AMCIS

Switzerland Europe

CARBOGEN AMCIS | Aarau

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

Certifications

ISO
FDA (cGMP)
World Health Organization (GMP / HACCP)
PMDA/MHLW (Japan GMP)

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)
DEA: N/A
BSL:
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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