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Services >> Biologics Development & Manufacturing >> Drug Product Development

Drug Product Development

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Eurofins CDMO (Contract Development & Manufacturing Organization) 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 Eurofins CDMO 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

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