SPOT LIGHT

How CARBOGEN AMCIS supports complex molecules and challenging formulations from early development to commercialisation

In an era defined by increasingly complex molecules and stringent regulatory demands, CARBOGEN AMCIS stands out as a contract development and manufacturing organisation (CDMO) partner delivering precision, adaptability and deep scientific expertise across every phase of drug development.

With more than 40 years of experience, CARBOGEN AMCIS provides an integrated suite of services spanning drug substance and sterile drug product development. As part of the Dishman Carbogen Amcis Group, the company operates eight state-of-the-art sites across Switzerland, France, the UK, the Netherlands and China, supported by a team of over 1,100 professionals. Its global footprint ensures consistent quality and regulatory compliance, with successful inspections from the US Food and Drug Administration, Swissmedic, Brazilian Agência Nacional de Vigilância Sanitária, and French Agence nationale de sécurité du médicament et des produits de santé.

CARBOGEN AMCIS offers a complete range of services for drug substance development, from preclinical studies through to commercial manufacturing. Its expertise encompasses:

• Process development and optimisation, including flow chemistry, chromatography, crystallisation and process criticality assessment

• Highly potent active pharmaceutical ingredients (APIs), antibody-drug conjugates (ADCs) and bioconjugates, managed in advanced containment facilities with demonstrated handling down to 0.01µg/m³ occupational exposure limit

• Analytical excellence, covering characterisation, stability testing, reference standards and regulatory compliance

• Scalable manufacturing, supporting gram-scale to 6,300L batch sizes

• End-to-end support, including non-good manufacturing practices (GMP) and GMP supply, tech transfer and life cycle management.

This integrated approach ensures a seamless transition from early development to market-ready APIs, whether for small molecules, biologics or complex conjugates.

The company’s dedicated sterile drug product facility in Saint-Beauzire, France, offers end-to-end capabilities for liquid and lyophilised injectables. GMP-certified and Annex 1 compliant, the site provides clinical and small-scale commercial supply, with two automated isolator-based lines. Key highlights include:

• Dual production lines: line 1 for liquid and lyophilised vials; Line 2 for liquid formats including future pre-filled syringes and cartridges

• Advanced formulation expertise: including low-temperature, inert-atmosphere and light-sensitive solutions

• High containment: capable of handling Category 1 to 4+ APIs

• Flexible batch sizes: suitable for technical, clinical and commercial requirements

• In-house quality control and microbiology labs: with full analytical capabilities, including high performance liquid chromatography, liquid chromatography-mass spectrometry and ICH stability studies

• Dedicated R&D and process optimisation labs: equipped with gloveboxes, isolators and lyophilisers.

With over two decades of experience in sterile manufacturing, CARBOGEN AMCIS delivers precision and reliability for even the most demanding drug product projects.

Capability spotlight: handling the most potent compounds

From cytotoxics to complex ADCs, CARBOGEN AMCIS provides a uniquely integrated pathway from drug-linker synthesis to final drug product. State-of-the-art containment systems and specialised staff ensure that even the most potent molecules can be managed safely, efficiently and in full regulatory compliance.

Recent investments reflect the company’s ongoing commitment to scientific excellence and client success:

• ADC cleanroom suite in Bubendorf, Switzerland, supporting advanced bioconjugation capabilities

• Advanced R&D and analytical labs in Saint-Beauzire

• Flow chemistry platforms supporting efficient process intensification

• Multi-site technology transfer frameworks to accelerate scale-up and reduce cost.

With a validated Media Fill Test strategy, the Saint-Beauzire facility has demonstrated a global lead time of six days, with a maximum lyophilisation cycle duration of 96 hours.

Whether you’re advancing a pioneering biologic or scaling production for a high-potency compound, CARBOGEN AMCIS brings together regulatory insight, flexible project management, and deep technical expertise to support your goals.

Learn how CARBOGEN AMCIS can advance your next sterile injectable or high-potency API with speed, precision and quality.