Biologics Drug Product Development
Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies provides a wide range of biopharma services, including biological manufacturing, with well equipped R&D labs and 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.
We have an excellent in house experience with all kinds of biologicals including proteins, (cyclic) peptides and oligonucleotides. The broad set of available analytical techniques will help to characterize these different types of biologicals and support drug product development, scale-up and manufacturing. We support the development of different administration routes going from sterile parenterals to oral solution or tablets. For biologicals which are at risk of not meeting the stability criteria, freeze-drying development can be your go-to with support of Eurofins CDMO throughout the entire process: from the screening of lyo-/cryo-protectants, the freeze-drying cycle optimization to scale-up and manufacturing. More information on the formulation development for biologics on the (pre-)formulation page.
GMP manufacturing capabilities include:
-
- Solutions (sterile and non-sterile)
- Freeze drying
- Spray drying
- Wet granulation
- Dry granulation
- Bead layering
- Tablet manufacturing
- Capsules (encapsulation/over-encapsulation)
- Microsuspensions
A wide range of analytical techniques are available for QC of the drug product:
-
- Assay-purity (HLPC/UPLC)
- Purity (SDS-PAGE, cIEF, CE-SDS)
- Particle size distribution
- Water content (KF)
- Subvisible particles
- 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 excipients (anti-oxidants, preservatives, surfactant, …)
- Strong background in freeze drying of biologicals from R&D phase to scale-up and manufacturing
- Fast knowledge transfer from process development phase to GMP manufacturing
- Analytical methods evolved together with drug product from early development phases
- Sterile and non-sterile manufacturing capabilities tailored to your need
