Biologics - DS/DP Development & Manufacturing
Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies 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 team optimizes expression of prokaryotic and eukaryotic organisms including generation of cell banks. We develop the complete purification process optimized for rapid delivery of high quality material for your preclinical and toxicology studies, and scalable – if not even fully representative – for production of clinical supply for Phase I and beyond. During the production process we cover the complete analytical package for your product.
We also perform innovative formulation development for optimal stability and bioavailability with solutions for solid and liquid dosage forms of manufacture proteins and bacteria or peptides and oligonucleotides. Drug product development services include preclinical development, formulation screening, analytical development and stability studies. We provide solutions for different delivery routes of your product including parenteral, oral (enteric coated), nasal and ophthalmic delivery.
Eurofins CDMO network of companies delivers biological drug products according to the desired dosage form for production of sterile and non-sterile batches for preclinical or early phase clinical studies. We can scale up for drug product clinical trial manufacturing, as well as commercial manufacturing of small batches and orphan drugs. We also work with clients and CMOs to provide seamless process transfer for large scale commercial manufacturing.
With more than two decades of manufacturing experience and 13 state-of-the-art facilities worldwide, we provide high-quality, customized solutions for complex products and unique production processes.
Choose 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).
? 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.
Our offer:
| Biologics Development & Manufacturing Services | ||
| Cell Banks (Research, Master, Working and End-of-Production) | Drug Substance | Drug Product & Formulation |
| Analytical Support | GMP Manufacturing (Clinical & Commerical Batches) | QC Testing and Batch Release |
| Process Transfer | ||
| Biological Product Types | ||
| Recombinant Proteins | Vaccines | Biological Raw Materials |
| Monoclonal Antibodies | Microbial Cells | Proteins Purified from Natural Sources |
| Delivery Methods | ||
| Parenteral | Oral | Nasal |
| Ophthalmic | ||
| Dosage Forms | ||
| Liquid | Solid | Semi-Solid |
