CARBOGEN AMCIS

CARBOGEN AMCIS is a global Contract Development and Manufacturing Organisation (CDMO) providing drug development and commercialisation services to the pharmaceutical and biopharmaceutical industries at all stages of drug development.

Our capabilities include contract chemical process research and development, accelerated early-phase development support through our SPRINT offering, supply of Active Pharmaceutical Ingredients (APIs), and drug products for preclinical studies, clinical trials, and commercial use, as well as high-quality Cholesterol and Vitamin D analog products.

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We have extensive experience in supporting pharma and biotech companies in the successful development, manufacturing, and market launch of innovative drugs.

As a Dishman Carbogen Amcis Group member, we have a global presence with eight sites located in Switzerland, UK, France, the Netherlands, and China, employing more than 1,100 people worldwide. 

Drug Substance CDMO

We excel in Drug Substance development, offering comprehensive support throughout the entire drug development lifecycle. Our capabilities include process development, optimisation, accelerated early-phase development support, and scalable manufacturing of Highly Potent (HiPo) active pharmaceutical ingredients (APIs). By prioritising quality, safety, and efficiency, we help our clients streamline drug substance development, accelerating the path to market approval.
Our end-to-end drug substance CDMO services bridge the gap between clinical drug development and commercialisation.

Through the SPRINT offering, CARBOGEN AMCIS provides agile, cross-functional support designed to accelerate early development timelines and decision-making.
We offer a wide range of services including non-GMP supply, rapid early-phase development support, Clinical API supply, Commercial API supply, Stability studies and Reference standards. Our areas of expertise encompass HiPo APIs, ADCs and bioconjugation, chromatography, crystallisation, integrated analytical services, flow chemistry, process criticality assessment and stability studies. 

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Key Facts

  • Over 40 years of experience in clinical API contract manufacturing
  • Capabilities ranging from gram-scale production to several thousand kilograms
  • Supporting projects from early clinical trials to commercial supply at scales up to 6,300 litres
  • Six dedicated sites worldwide specialising in drug substance development and manufacturing
  • Agile early-phase development support through the SPRINT offering

CARBOGEN AMCIS

Drug Product CDMO

Our expertise in Drug Product development encompasses a wide range of pharmaceutical services. From early formulation development to commercial-scale manufacturing, we specialise in efficiently bringing your Drug Product to market while ensuring full compliance with regulatory standards. Our highly skilled team at our state-of-the-art facility in Saint-Beauzire, France, ensures that your Drug Product is manufactured with precision and meets the highest quality standards.

At CARBOGEN AMCIS, we have the specialised skills and extensive experience required to develop and manufacture sterile drug products. Our expertise spans pharmaceutical sciences, microbiology, engineering, and process development, enabling us to deliver exceptional results.

We excel in drug formulation, sterilisation methods, and aseptic pharmaceutical manufacturing. With a deep understanding of regulatory standards, we ensure the safe development and production of sterile Drug Products in full compliance with Good Manufacturing Practices (GMP) and other applicable guidelines.
Our integrated approach supports efficient progression from early development through to clinical and commercial manufacture.

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We offer Drug Product development services, industrial transfer, Clinical and commercial drug product manufacturing, Release testing and stability studies as well as QP services and regulatory support. 

Key Facts

  • Over 20 years of expertise as a Drug Product CDMO
  • Specialising in the development and manufacturing of sterile Drug Products
  • Providing both liquid and lyophilised Drug Product solutions
  • State-of-the-art facility designed for clinical and commercial supply, compliant with Annex 1 regulations
  • Expertise in handling complex compounds, challenging formulations, and high-potency compounds
  • Integrated sterile drug product development and manufacturing support from early-phase to commercial supply

Customer Journey at CARBOGEN AMCIS – Episode 2: Advancing ADC and Drug Product Solutions

Cholesterol and Vitamin D Manufacturing

CARBOGEN AMCIS has a strong presence in the manufacturing, marketing, and distribution of Vitamin D analogs, Vitamin D2, cholesterol, and lanolin derivatives.

These products are utilised across a wide range of industries, including pharmaceuticals, cosmetics, animal feed, food, shrimp farming, and industrial applications.

With over 70 years of experience, we have established ourselves as a trusted partner in the development, production, and global supply of these ingredients. Our production site in Veenendaal operates under a cGMP regime, holds EU GMP certification, and is classified as acceptable by the US FDA for API manufacturing.

Our comprehensive services include the production of Vitamin D analogs and Vitamin D2 products, cholesterol and lanolin derivatives, and Cosmetic GMP manufacturing. https://www.carbogen-amcis.com/specialities

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Key Facts

  • Over 70 years of experience in Vitamin D and cholesterol manufacturing
  • EU GMP-certified, cGMP-compliant, and US FDA-approved production site in Veenendaal
  • Serving diverse industries, including pharmaceuticals, cosmetics, and food production
  • Expertise in high-quality cholesterol, Vitamin D analogs, and lanolin derivatives

At CARBOGEN AMCIS, our flexible approach allows customers to benefit from tailored work packages that balance speed, cost, and quality. We also customise our communication and reporting processes to align with each customer’s specific requirements and documentation standards. This commitment to adaptability and excellence ensures efficient project delivery and consistently high-quality outcomes.

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Contact us

+41 58 909 00 00

info@carbogen-amcis.com

 

Bubrndorf (Headquarters)

CARBOGEN AMCIS

Hauptstrasse 171

CH-4416 Bubendorf

Switzerland

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