Biologics
Eurofins CDMO (Contract Development & Manufacturing Organization) provides integrated, end-to-end drug development solutions supporting clients from gene development through finished product.
We offer a full suite of drug development services encompassing development of the bioprocesses for a broad range of products, formulation screening, analytical development, pre-clinical testing, sterile and non-sterile bio-manufacturing of clinical trial batches, small commercial batches and orphan drugs. The group delivers solutions for the development and biomanufacturing of antibodies, proteins, enzymes, vaccines and different types of bacteria.
Our Capabilities Include:
- Cell Banks
- Drug Substance Development
- Pre-Formulation / Formulation Screening
- Drug Product Development
Why should you select us:
✔ 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).
✔ Produce cell banks, including research, master, working and end-of-production cell banks.
✔ Develop innovative formulations for liquid and solid dosage forms for proteins, oligonucleotides, peptides or microorganisms for various delivery routes.
✔ 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).
✔ Produce batches for preclinical and early phase clinical studies.
✔ Manufacturing small batches and orphan drugs.
✔ Offer regulatory support throughout the complete development pathway.
