With 20+ years of experience in drug development and manufacturing and a global presence with state-of-the-art facilities, we deliver high-quality & customised solutions for complex products.

Our expertise

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.

adobestock_46595127

API bioavailability enhancement

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 programmes from API through to drug product development.

Expand_img

Particle size reduction

  • Control particle size through the API and Drug Product development lifecycle
  • Perform solid state characterisation to assess and control physicochemical properties
  • Conduct pre-formulation studies to evaluate solubility and permeability
  • Perform IND enabling API and drug product development
  • Perform clinical and commercial manufacturing for both non-potent and highly potent compounds
  • Integrate services to enable technical challenge resolution in real time 
  • Expertise in jet milling, nano milling

SEDDS (Self-Emulsifying Drug Delivery System) / SMEDDS (Self Microemulsifying Drug Delivery System) Formulation

  • Overcome challenges associated with first-pass metabolism through SEEDS/SMEDDS, a lipid based formulation to enhance bioavailability

Spray Drying

  • Development from g scale to 100s of grams
  • GMP spray drying at multi-kilo scale in support of a wide range of finished dosage forms

Our Highway to Clinic platform offers a comprehensive approach, screening different drug product innovative formulation technologies, to overcome bioavailability enhancement.

adobestock_115282973

Pre-formulation & compatibility studies

Focusing on understanding the physical and chemical properties of the drug molecule (e.g. solubility, stability, polymorphism) and testing the interaction between the drug substance and excipients. In collaboration with our solid-state R&D experts, we assess solubility and rank drug candidates to optimise bioavailability.

adobestock_77178317_form

Formulation optimization

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), to achieve the desired drug release profile, stability, and manufacturability

Expand_img

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:

  • Multiparticulate systems like mini tablets or beads
  • Bilayer / multilayer tablets
  • Hard capsules
  • Tablets
  • Orodispersible tablets
  • Amorphous solid dispersions
  • Solutions
  • Micro- and nanosuspensions
  • (Micro-) emulsions
  • Creams / gels / ointments
  • Powders
adobestock_564054966-bceu002lap53849

Eurofins CDMO has different state-of-the-art coating techniques carried out in-house (fluid bed coating, drum coating) to formulate coated drug products with a colon targeted release.

alphora_pilot-plantt

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 specialise in process transfer and scale-up strategies, providing a seamless transition of programmes from development through to later stage manufacturing.

adobestock_492195609-1 (2)

Comprehensive documentation of all formulation development activities and data, preparing regulatory submissions

adobestock_528567825_preview

Let's advance your innovation together