High-potency API expertise: bringing complex compounds to market with confidence

With a strong track record in complex chemistry, CARBOGEN AMCIS offers end-to-end drug substance solutions, from preclinical development to commercial supply.

We excel in drug substance development, offering comprehensive support throughout the entire drug development life cycle. Our capabilities include process development, optimisation and scalable manufacturing of highly potent (HiPo) 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

We offer a wide range of services including non-good manufacturing practice (GMP) supply, clinical API supply, commercial API supply, stability studies and reference standards. Our areas of expertise encompass HiPo APIs, antibody drug conjugates (ADCs) and bioconjugation, chromatography, crystallisation, integrated analytical services, flow chemistry, process criticality assessment and stability studies.

Capabilities:

• Process development and optimisation: Proficiency in flow chemistry, chromatography, crystallisation and process criticality assessment to ensure efficient, high-quality production

• Highly potent compounds: Advanced containment facilities and expertise in handling HiPo APIs, ADCs and bioconjugates

• Analytical excellence: Robust tools for characterisation, stability testing, reference standards and regulatory compliance

• Flexible manufacturing scales: Supporting projects from gram-scale production to 6,300L capacities for both clinical and commercial supply

• End-to-end support: Services include non-GMP supply, clinical and commercial API manufacturing, stability studies and more.

By prioritising quality, safety and efficiency, CARBOGEN AMCIS bridges the gap between clinical drug development and commercialisation, delivering tailored solutions to each project’s unique challenges. Whether working with small molecules, biologics or complex compounds, the company’s extensive experience and state-of-the-art facilities make it a trusted partner for accelerating the path to market approval.

Watch our video to find out more about the customer journey at CARBOGEN AMCIS – taking you from bench to market.