ADVERTORIAL
From molecule to market
Carbogen Amcis ' s integrated expertise in high-potency and complex drug products
In an era where drug development timelines are under constant pressure, integrated expertise across the entire product lifecycle can make the difference between success and delay. Carbogen Amcis, a global CDMO, combines over 40 years of drug substance expertise with state-of-the-art sterile drug product manufacturing capabilities, offering a seamless pathway from molecule to market. Unlike many CDMOs, Carbogen Amcis coordinates its services across multiple sites, enabling a smooth transition from early development to commercial supply without compromising quality or speed.
Global network & specialist capabilities
Operating eight world-class facilities across Europe and Asia, Carbogen Amcis provides:
• Contract chemical process R & D
• API supply for preclinical, clinical and small-scale commercial use
• Advanced handling of highly potent APIs( HPAPIs) and antibody-drug conjugates( ADCs) with containment down to OEL 0.01 μg / m ³
Seamless multisite integration
This coordinated, multi-site approach allows projects to progress efficiently through the full development cycle. For example, work can begin with non-GMP building blocks at our Manchester site, move into advanced development in Switzerland, and continue through to clinical and commercial supply at our Saint-Beauzire facility in France.
By removing barriers between stages, we minimise transfer risks, shorten timelines, and ensure quality and compliance at every step. The Saint-Beauzire site is a prime example of this seamlessly linked model in action, serving as the company’ s flagship centre for sterile drug product development and manufacturing.
Saint-Beauzire: Capabilities at a glance
Fully GMP-certified and Annex 1-compliant, the Saint-Beauzire site is designed to handle both clinical through to niche commercial supply. Key features include:
• Two fully automated, isolatorequipped production lines:
• Line 1: Liquid and lyophilised forms in vials
• Line 2: Liquid forms in vials( future capability for prefilled syringes and cartridges)
• Integrated R & D laboratories for formulation development and process optimisation
Complex formulation expertise
Saint-Beauzire offers advanced solutions for:
• Low-temperature and inertatmosphere processing
• Light-sensitive and poorly soluble APIs
• Challenging formulations requiring specialised environments
With development, manufacturing and analytical capabilities all on one site, the facility provides comprehensive technical support for complex projects— from fine-tuning formulation parameters to validating robust, compliant processes for commercial readiness.
End-to-end project support
Drawing on expertise across all Carbogen Amcis sites, crossdisciplinary teams in chemistry, microbiology, engineering and regulatory science deliver:
• Seamless continuity between project stages
• Reduced transfer risks through close coordination
• Accelerated timelines without compromising quality or compliance
For pharmaceutical and biopharmaceutical innovators looking to streamline development, reduce risk, and bring complex therapies to patients faster, Carbogen Amcis offers the expertise, infrastructure, and flexibility to make it happen.
DISCOVER HOW WE CAN SUPPORT YOUR NEXT BREAKTHROUGH
J j info @ carbogen-amcis. com www. carbogen-amcis. com
SEP / OCT 2025 SPECCHEMONLINE. COM
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