Drug Product Development
Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies has state-of-the art cleanroom facilities for GMP (Good Manufacturing Practice) compliant clinical supply manufacturing, packaging and labeling of liquid, semi-solid and solid dosage forms on lab and pilot scale. Clinical supplies or Investigational Medicinal Products (IMPs) are quality controlled and released by a Qualified Person. We can also provide blinding and randomization of clinical materials.
GMP manufacturing capabilities include:
- Solutions
- Microsuspensions
- Nanosuspensions
- Amorphous Solid Dispersions
- S(M)EDDS
- Spray drying
- Freeze-drying
- Fluid bed granulation
- Bead layering
- Tablet manufacturing
- Capsules (encapsulation/over-encapsulation)
A wide range of analytical techniques are available for QC of the drug product:
- Forced degradation studies
- Assay-purity (HLPC/UPLC/LC-MS)
- Dissolution
- Particle size distribution
- Elemental impurities evaluation (ICHQ3D)
- Water content (KF)
- Characterization (DSC, XRD, SEM, Raman, FTIR, (hot stage) microscopy, rheometer, …)
- Stability studies
- Excipient compatibility studies
- Accelerated stability studies
- ASAP (Accelerated Stability Assessment Program)
- ICH stability studies (Zone, I, II, III, IV) semi-permeable containers
- Microbiology
- Sterility
- Bioburden
- Absence of host cell proteins
- Endotoxin determination
- Quantification of API and excipients
Bioactivity/potency assay
Choose the Eurofins CDMO network of companies for your drug product development:
- Sterile and non-sterile manufacturing capabilities tailored to your need
- Fast knowledge transfer from process development phase to GMP manufacturing
- Analytical methods evolved together with drug product from early development phases
