Biologics - DS/DP Development & Manufacturing
Eurofins CDMO offers a wide range of integrated drug development services, including upstream and downstream processing, protein formulation, and biomanufacturing. With state-of-the-art facilities and extensive expertise, we deliver customized solutions for biologics drug development and biological manufacturing.
Comprehensive Drug Development Solutions for Biopharmaceuticals
Eurofins CDMO (Contract Development & Manufacturing Organization) is a global network of companies dedicated to providing end-to-end solutions for drug development. Our integrated services support clients throughout the entire process, from gene development to the finished product. With over two decades of manufacturing experience and 13 state-of-the-art facilities worldwide, we specialize in delivering high-quality, customized solutions for complex biopharmaceutical products and unique production processes.
Comprehensive Suite of Drug Development Services
At Eurofins CDMO, we offer a full suite of drug development services to meet the diverse needs of our clients. Our services include the development of bioprocesses for a wide range of products, formulation screening, analytical development, pre-clinical testing, and sterile and non-sterile bio-manufacturing. We have extensive expertise in the development and biomanufacturing of antibodies, proteins, enzymes, vaccines, and various types of bacteria.
Optimized Expression and Purification Processes
Our team specializes in optimizing the expression of prokaryotic and eukaryotic organisms, including the generation of cell banks. We develop complete purification processes that are optimized for rapid delivery of high-quality materials for preclinical and toxicology studies. These processes are scalable and can be fully representative for the production of clinical supply during Phase I and beyond. Throughout the production process, we provide a comprehensive analytical package for your product, ensuring its quality and compliance.
Innovative Formulation Development
Eurofins CDMO excels in innovative formulation development to enhance stability and bioavailability. We offer solutions for solid and liquid dosage forms of manufacturing proteins, bacteria, peptides, and oligonucleotides. Our drug product development services encompass preclinical development, formulation screening, analytical development, and stability studies. Additionally, we provide solutions for different delivery routes, including parenteral, oral (enteric coated), nasal, and ophthalmic delivery, tailored to meet the specific requirements of your product.
Scalable Manufacturing Capabilities
As part of our commitment to supporting clients throughout the entire drug development journey, Eurofins CDMO delivers biological drug products in the desired dosage form. Whether it's sterile or non-sterile batches for preclinical or early phase clinical studies, we can scale up for drug product clinical trial manufacturing. Additionally, our expertise extends to commercial manufacturing of small batches and orphan drugs. We also collaborate with clients and contract manufacturing organizations (CMOs) to ensure seamless process transfer for large-scale commercial manufacturing.
Partner with Eurofins CDMO
With Eurofins CDMO as your partner, you gain access to our vast experience and state-of-the-art facilities. Our team of experts is dedicated to delivering high-quality, customized solutions for biopharmaceutical development and manufacturing. We understand the unique challenges associated with biologics drug development and provide tailored approaches to meet your specific needs. Contact us today to discuss how we can support your drug development journey.
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.
