Drug Substance
Comprehensive Solutions for Biological Drug Substance Production
Eurofins CDMO network of companies takes pride in delivering cutting-edge solutions for the development and biomanufacturing of a diverse range of biologics, including antibodies, proteins, enzymes, vaccines, and various types of bacteria. All innovative products begin with proof-of-concept studies, and we offer small research scale productions to meet initial activity study needs. Our facilities are designed for scalability, ensuring seamless transition to larger batches while addressing potential regulatory challenges. We offer cost-efficient non-GMP batches without compromising on quality, thanks to the segregation in our facilities.
Central to our operations is our expertise in developing bioprocesses for a broad spectrum of products, including proteins. Once a molecule demonstrates efficacy, we work diligently to develop a production process optimized for swift delivery of high-quality material for preclinical and toxicology studies. Our processes are designed to be scalable, making them suitable for the production of clinical supplies for Phase I and beyond. Leveraging our extensive CMC expertise and scientific experience, we develop GMP manufacturing programs that strike the right balance between speed, budget, scalability to Phase III and commercial production volumes, and regulatory compliance.
Cutting-Edge Technologies for Biological Drug Substance Production
Eurofins CDMO network of companies brings advanced technologies to optimize the production of biological drug substances. Our team excels in optimizing the expression of prokaryotic and eukaryotic organisms and developing efficient purification processes. We have decades of experience in working with various microbial expression systems, from E.coli (soluble and insoluble, peri- and cytoplasmic) to high-efficiency yeast systems like Pichia and Hansenula. Additionally, we offer insect cell expression systems like S2 and Sf9 cells and mammalian expression platforms, including CHO, HEK293, NS0, and Per.C6 cells.
Streamlined Upstream and Downstream Processing
Our capabilities span both upstream and downstream processing to ensure a seamless and efficient production process for biological drug substances. In upstream processing, we offer various options for high-density fermentation, including batch, fed-batch, and perfusion mode. The process parameters are optimized in small scale experimental design studies, allowing for rapid identification of optimal fermentation and expression yield conditions.
In downstream processing, our experienced team develops purification protocols and downstream processes, including protein formulation. We employ a wide range of chromatography and filtration technologies, continuously updating and expanding our capabilities in this field. Additionally, our comprehensive portfolio of analytical competences covers biochemical and biophysical methods, as well as bioassays, ensuring the monitoring and characterization of critical attributes throughout the production process.
Choose Eurofins CDMO for Your Biological Drug Substance Needs
Experience the flexibility and expertise of Eurofins CDMO network of companies for your biological drug substance production. Our advanced technologies and in-house alignment of cell line development, upstream processing, downstream purification, and analytical QC ensure a streamlined and efficient process tailored to your specific requirements. Together, we can plan the most time-saving and economically viable production process for your biological drug substances.
