BioPharmaceuticals Production
We produce clinical trial and commercial material for all major markets according to FDA, EMA and PMDA requirements. We manufacture biopharmaceuticals from bacteria and yeast and offer significant know-how in the transfer, optimization and development of scalable and robust processes.
Highly scalable manufacturing from gram to kg quantities of plasmid for use as DNA vaccines, non-viral gene therapy or starting material for viral vector production.
More than 30 years of experience in the production and purification of recombinant proteins for human use, we are ready for your project goals.
Experience coupling peptides, proteins, polysaccharides and PEG to proteins for use human use with numerous coupling strategies.
We take your project from your lab to GMP production.
Eurogentec can transfer, develop and optimize fermentation, purification and quality controls methods required to manufacture protein and plasmid material for clinical and commercial uses.
We are a FDA inspected company.
We are focused on microbial production and have 30+ years experience in process development and GMP manufacturing.
Our 2200L facility is designed as a multi-product GMP facility.
We are able to produce recombinant proteins from E.coli and P.pastoris at this scale. The facility is designed to allow the safe use of methanol induction for host systems that require it.
The facility is also designed for large-scale production of plasmid DNA.
All production is done to US, EU and Japan human injectable quality standards.
I am satisfied with your work especially with respect to: very close contact with open mindedness, sincere attitude for customer and building up the relationship as collaborator.
We have received our IND approval from the FDA without serious comments in the CMC section, this could not have been achieved without the advice and collaboration of Eurogentec.
I would like to thank you and your team for the last production. Again, it was a pleasure to cooperate with you. We were very impressed that you were able to meet the tight timelines.
You've done a great job. By far, this GMP batch was the smoothest run I've ever experienced.
The reports are consistently of a high standard, succinct yet detailed, comprehensive, well articulated and easy to integrate into our system. Well done and please thank all staff that have been involved.
