With 20+ years of experience in drug development and manufacturing, and a global presence with state-of-the-art facilities, we deliver high-quality, customized solutions for complex products.
Eurofins CDMO offers expert drug product development and manufacturing across solid, semi-solid and liquid dosage forms for oral, nasal, buccal, topical, ocular, and parenteral delivery.
Focusing on understanding the physical and chemical properties of the drug molecule (e.g. solubility, stability, polymorphism). In collaboration with our solid-state R&D experts, we assess solubility and rank drug candidates to optimise bioavailability.
Based on pre-formulation data, various formulation strategies are explored based on a quality by design approach to develop a stable and effective drug product. This involves selecting appropriate excipients and dosage forms (dependent on the drug’s characteristics and intended route of administration).
At Eurofins CDMO, we specialise in developing innovative formulations that provide solutions to enhance bioavailability e.g. Highway to Clinic platform for poorly soluble compounds) and control drug release (e.g colon targeting), especially for challenging-to-formulate drug candidates:
Compatibility studies are performed to evaluate potential interactions between the drug substance and selected excipients, packaging components, or formulation matrices. Our experts identify the impact on the assay, related substances, physical appearance, stability, and overall product performance, supporting the selection of suitable formulation components during development.
Our expertise lies in formulation and manufacturing process optimization. We identify critical process parameters, define design space, improve product performance, and enhance process robustness through data-driven approaches. Formulation optimization focuses on reducing variability, increasing yield, and supports efficient scale-up from development to clinical & commercial manufacturing.
We partner with clients to design formulation approaches that not only address complex development challenges but also create opportunities for proprietary product differentiation and intellectual property protection.
Our core focus is GMP clinical drug product manufacturing. Our state-of-the-art facilities and GMP compliant systems are specifically designed for quick-to-clinic operations. We specialize in process transfer and scale-up strategies, providing a seamless transition of programs from development through to later stage manufacturing.
Comprehensive documentation support for regulatory submissions, ensuring that development, manufacturing, and analytical data are accurately compiled and presented. We work closely with clients to prepare high-quality QbD based technical reports and CMC documentation that facilitate efficient regulatory filings and reviews.
To improve the solubility and enhance the effectiveness of the drug, our (pre)-formulation and solid state teams work together using their expertise and proven track record to quickly advance programs from API through to drug product development.