Eurogentec Biologics offers cGMP manufacturing of GMP mRNA, plasmid DNA (linear and circular), recombinant proteins, and protein conjugates for all clinical phases and commercial manufacturing.
US FDA inspected 2011, 2013, 2014, 2017
GMP Product offering:- mRNA
- Plasmid DNA, super-coiled (up to kg scale)
- Plasmid DNA, linear
- Recombinant proteins (cytokines, antibody fragments, VHH, enzymes, etc)
- Protein conjugates (protein-peptide/protein/PEG etc)
- Antibiotic free selection and production methods
Service offering:- Upstream process transfer / development (DoE, FastTrack, OptiTrack)
- Downstream process transfer / development (Screening technologies)
- QC development / qualification / validation
- Stress stability studies
- GMP Cell Banking
- GMP API manufacturing
- GMP Drug Product manufacturing
- Process characterisation / validation
- ICH Stability Studies
- On-site Qualified Person (QP) release
Host systems:significant experience working with
- E. coli,
- P. pastoris,
- S. cerevisiae
- numerous BSL2 organisms
- any non-spore forming aerobic microbial organisms
Company History:- GMP accreditation in 1994 by the Belgian Ministry of Health
- Authorization to manufacture injectable GMP material
- Developed over 180 different GMP microbial processes
- Released over 700 GMP batches
- US FDA inspected 2011, 2013, 2014, 2017
Client portfolio:- Big Pharma, biotechs, virtual companies
- Europe, North America, Asia and Africa
Eurogentec is part of Kaneka Corporation