Carbogen Amcis

Overview

Carbogen Amcis is a global CDMO providing integrated drug substance to drug product services across all stages of pharmaceutical development and commercialization. The company operates 8 sites across Switzerland, UK, France, Netherlands, and China, with over 40 years of experience in clinical API development.

Drug Substance Services

• API Development & Manufacturing: Comprehensive support from early-phase development through commercial-scale production, with capacity from gram to several thousand kilograms
• Process Development: Advanced capabilities including route scouting, process optimization, and scale-up support
• Analytical Services: Advanced characterization (absolute configuration, solubility profiling, salt screening, polymorphism, particle sizing, impurity profiling); method development, validation, and verification; specification development and justification
• Stability Studies: Stress stability, API stability, drug product stability, and degradation profiling
• Specialty Chemistry: Expertise in bromination, nitration, borylation, cryogenics (−80°C capable), hydrogenation, chiral synthesis, cyclization, and photochemistry
• Starting Materials & Intermediates: Manufacturing of API starting materials with technical transfer assistance

Drug Product Services

• Sterile Injectable Manufacturing: State-of-the-art facility for development and manufacturing of injectable drug products
• Fill-Finish Capabilities: Vial filling and related sterile manufacturing operations

Specialized Products

• Cholesterol and Vitamin D analogs
• GMP cosmetics and specialty chemicals

Manufacturing Infrastructure

• Pilot plant with reactors ranging 85 L to 4,500 L
• Operating temperature range: −80°C to +200°C; pressures up to 3 bar
• Modern kilo lab with four 25 L vessels and cryogenic capabilities
• Large-scale downstream chromatography facilities
• Complete analytical suite including on-site NMR
• Up to 6,300 liters of API production capacity

Regulatory & Quality

• NMPA GMP compliance confirmed at Shanghai site (unannounced inspection, no observations)
• Chemical Industries Association (CIA) recognition for manufacturing excellence and sustainability
• Full regulatory documentation and support throughout development lifecycle