From formulation to clinical supplies
Eurofins CDMO 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 biologics. The broad set of available analytical techniques will help to characterize these different types of biologics 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.
Our expertise for your biologics Drug Product
Choose the Eurofins CDMO network of companies to help you:
- Accelerate pre-clinical and clinical phases of your product with easy scale-up and smooth transfer from development to GMP facilities, including fill & finish suites (manufacturing under isolator and single-use material).
- Perform complex formulation screening and development with a vast array of innovative technologies.
- Enhance bioavailability of poorly soluble drugs and controlling drug release.
- Develop and validate stability indicating methods, as well as stability evaluation of drug substances and developed drug products, including Accelerated Stability, ICH Stability, In-Use Stability, and Accelerated Stability Assessment Programs (ASAPs).
- Perform clinical trial manufacturing of non-sterile and sterile drug products.
- Perform commercial manufacturing (small commercial batches) and Orphan drugs.
- Ensure regulatory support throughout the complete development pathway.