Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC)

Our facility located in Bubendorf – a municipality in the district of Liestal in the canton of Basel-Country in Switzerland – is the current headquarters of CARBOGEN AMCIS.

The larger scale production facility was opened in 1987, and in more than 25-year of history it has continuously adapted to the changing needs of the pharmaceutical industry.

Activities

• Process optimization and supply of late-phase and commercial APIs
• Highly potent manufacturing up to 100 kg scale, up to Category 4
• Bioconjugation manufacturing
• Chromatography capabilities (including highly potent compounds)

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

Development and medium scale manufacturing

Our facility in Hunzenschwil (Neuland) – in the district of Lenzburg in the canton of Aargau in Switzerland – is located 25 km West of Zurich. The facility was opened in 2000 and is our second site to house laboratories for development activities with highly potent compounds. The site will be expanded with a new API plant. Construction works will begin in 2021. The new facility will fully operate by summer 2024.

Activities

• Analytical services
• API and intermediate stability studies
• API process research and development
• Small scale commercial API supply

Development HiPo and small scale production including chromatography and lyophilisation

Our facility in Vionnaz which opened in 2015 is located 70 km east of Geneva and is fully cGMP compliant. The site features a process development laboratory, a dedicated QC laboratory and 2 production units fitted with reactors up to 30 L, chromatography and a freeze dryer for lyophilisation.

Activities

• Development and manufacture of highly potent APIs & Intermediates
• cGMP Manufacturing
• Support Activities
• Scale-Up Services

Development and manufacturing and non-GMP

Our facility in Manchester is fully integrated into the in-house supply chain for complex APIs.

Activities

• Process research and custom synthesis of pharmaceutical intermediates, cosmetic ingredients and fine chemicals
• Larger production capacity (up to 4,500 L)
• Production of early-phase APIs and large-scale intermediates

Drug product - Early phase

Our 10,000 square meter facility in Riom opened in 1998. Our site focuses on formulation, aseptic filling, cytotoxics as well as other highly potent drugs and biologics. A new facility approximately 7 km away from the existing site will be added in Saint-Beauzire. Operations at the new site are slated to start by April 2023.

Activities

• Development and aseptic production of drug products
• Clinical Manufacturing
• Pharmaceutical development
• Sterile Fill & finish and Freeze dried products
• Vials and Pre-filled Syringes
• Biological Products and ADC
• Highly Potent, Controlled Substances and Toxins
• Complex Aseptic Processing For Drug Delivery Systems

Custom development and automated aseptic production of liquid and lyophilized drug product

Our new state-of-the-art facility, opened in Q1 2023, is dedicated to the development, sterile production, testing and release of injectable drug products. This facility has two fully automated filling lines and will allow CARBOGEN AMCIS to supply customers with clinical batches for phase III clinical trials and small-scale for commercial. The facility has the capability to handle complex formulations, including a large range of APIs from biologics to highly potent compounds.

Activities

• Two production lines offering liquid and lyophilized sterile injectable drug product
• Aseptic formulation of up to 400 litres
• Handling of Highly Potent products with OEB 4+ category
• Drug product formulation development and analytical method development, transfer and validation
• State of the art chemistry laboratories to support in-process and finished product testing
• Microbiological platform to perform bioburden, sterility and endotoxin testing
• Stability chambers to support ICH stability studies

Large scale manufacturing

Shanghai, the largest economic and trade center in China, contains our fully self-supporting GMP compliant development and production site. Our facility is located in the Shanghai Chemical Industry Park (SCIP) and is designed for large scale manufacturing of raw materials, intermediates and API.

The site is equipped with 13 reactors, segregated into 4 separate suites and has reactor capacities from 500 L to 8000 L. With an international team of highly qualified specialists, our facility can provide efficient and scalable solutions to customers globally.

Activities

• Large scale manufacturing of raw materials, intermediates and API
• Capable of manufacturing highly potent chemicals up to category 3
• Analytical capabilities allow GMP product release and analytical support for development activities

Large scale manufacturing of Cholesterol and Vitamin D analogs

CARBOGEN AMCIS B.V. is active in the manufacturing, marketing/sales and distribution of Vitamin D analogs, Vitamin D2, Cholesterol and Lanolin derivatives. These products are used in pharmaceuticals, cosmetics, (shrimp) feed, and industrial applications. Through our history of Dishman Netherlands, Philips, Roxane, Duphar, and Solvay Pharmaceuticals we have more than 70 years of experience in the development, production, sales and distribution of these products.

Activities

• Large scale dedicated Cholesterol production facility
• Vitamin D analog manufacturing
• Contract Research and Manufacturing Services