Eurogentec Biologics

Eurogentec Biologics offers cGMP manufacturing of GMP protein, protein conjugates, and plasmid DNA for Phase I, II, III clinical trials and commercial manufacturing.

US FDA inspected 2011, 2013, 2014, 2017


GMP Product offering:
  • Recombinant proteins (cytokines, antibody fragments, enzymes, etc)
  • Protein conjugates (protein-peptide/protein/PEG etc)
  • Plasmid DNA, super-coiled (up to 200g scale)
  • Plasmid DNA, linear
  • 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 of both Drug Substance and Drug Product

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 140 different GMP microbial processes
  • Released over 500 GMP batches
  • US FDA inspected 2011, 2013, 2014, 2017

Client portfolio:
  • Experience with all sizes of biotherapeutic companies, including Big Pharma, biotechs, virtual companies
  • Europe, North America, Asia and Africa

Eurogentec is part of Kaneka Corporation

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Locations


Belgium
Eurogentec Biologics
Liege Science Park
Rue Bois Saint-Jean, 14
Seraing,   4102
Belgium, Europe

GMP Experience
Eurogentec Biologics is a Contract Manufacturing Organisation (CMO) offering manufacturing of GMP protein, plasmid, vaccine and conjugates for Phase I, II, III and commercial uses.

Contacts


Pascal Bolon, PhD
Biologics Sales & Marketing Manager

Production Lines

Eurogentec Biologics    500L Fermentation
Location: Seraing, Belgium
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L500L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 18MAY17

Send Inquiry about this Production Line
Eurogentec Biologics    150L Fermentation
Location: Seraing, Belgium
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L150L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 18MAY17

Send Inquiry about this Production Line
Eurogentec Biologics    80L Fermentation
Location: Seraing, Belgium
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L80L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 18MAY17

Send Inquiry about this Production Line
Eurogentec Biologics    2200L Fermentation (coming soon)
Location: Seraing, Belgium
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  2000L-5000L2200L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  Bioreactor OnlyBioreactor Only
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 01SEP17

Send Inquiry about this Production Line

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