cGMP Fill/Finish Production Line


Innogenetics Biologicals

The one-stop-shop for cGMP-compliant Manufacturing, Fill & Finish of Antigens, Bacteria, Viruses and Vaccines.

Our Philosophy is to be "Transparent with your Time and Money".

Expertise :
• Extensive experience with cell-line and process development for manufacturing of proteins, fusion constructs and “recombinant” viruses
• Production of your biologicals of interest in a variety of bacterial or mammalian hosts
• Analytical method development
• Major US and EU Pharmaceutical companies as references
• Formulation and filling, including viruses in a cGMP compliant BL2 facility.

Facility :
• Top class cGMP facility
• Bio-Safety-Level 2 section
• Designed and equipped to facilitate customized production needs

Organization :
• The right Team for your request, in your Time-Frame
• Streamlined follow-through for on-time delivery
• Part of Fujirebio

Quality :
• Validation according to ICH guidelines
• Development and qualification of a widespread range of analytical methods
• Independent QC team for IPC and release testing
• Independent QA team with QP


Is this your Organization?   Request Access

Your Selected Production Line

Innogenetics Biologicals   cGMP Fill/Finish
Location: Ghent, Belgium
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
Supported Vial Size:  20+ ml20+ ml
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are Not AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 06JAN11

Send Inquiry about this Production Line

Locations


Belgium
Innogenetics Biologicals
Technologiepark 6
Ghent,   9052
Belgium, Europe

GMP Experience
• cGMP facility • Authorization No. 641 from Belgian Ministry of Health for API’s and DP, on behalf of EMA - European Medicines Agency.

Contacts


Frederic Caufrier, PhD
Business Development Manager Biologicals

Other Production Lines

Innogenetics Biologicals   Process development & cGMP Production - Microbial
Location: Ghent, Belgium
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Process:  PerfusionPerfusion
BioReactor Scale:  1L-100L100L Bioreactor
GMP Level:  Phase I/IIPhase I/II
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 AvailableViral Manufacturing
Availability: Available

Last Update: 06JAN11

Send Inquiry about this Production Line
Innogenetics Biologicals   Process development & cGMP Production - Cell line
Location: Ghent, Belgium
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Process:  PerfusionPerfusion
BioReactor Scale:  1L-100L100L Bioreactor
GMP Level:  Phase I/IIPhase I/II
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 AvailableViral Manufacturing
Availability: Available

Last Update: 06JAN11

Send Inquiry about this Production Line

Copyright © Kymanox, All Rights Reserved.