Novasep

Novasep is a GMP biomanufacturing company, able to bring your new biomolecules from gene up to the crucial clinical validation stage (clinical batches and clinical trials up to phase III).


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Locations


Belgium
NOVASEP HENOGEN
Rue des Professeurs Jeener et Brachet, 12
Charleroi,   6041
Belgium, Europe

GMP Experience
• 2 cGMP production sites • 2500 m2 of cGMP suites including 1800 m2 of class C clean rooms and 3 class A aseptic filling suites • 10 BSL2 and 3 BSL3
France
Novasep Process - Pompey
81 boulevard de la Moselle
Site Eiffel, BP 50
Pompey,   54340
France, Europe

GMP Experience
1500m² GMP suites for DSP, class C

Contacts


Cedric Delsemme

Production Lines

NOVASEP HENOGEN   Mammalian Cell Culture
Location: Charleroi, 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:  100L-2000L250L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Biosafety Level 3Biosafety Level 3
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: 02DEC09

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NOVASEP HENOGEN   Fermentation
Location: Charleroi, 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 IIIPhase III
Biosafety Level:  Biosafety Level 3Biosafety Level 3
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: 03DEC09

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NOVASEP HENOGEN   Viruses
Location: Charleroi, Belgium
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Scale:  100L-2000L250L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Biosafety Level 3Biosafety Level 3
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: 02DEC09

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NOVASEP HENOGEN   Multi-Purpose DSP Production Lines
Location: Charleroi, Belgium
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  5,000-20,0005,000-20,000
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 3Biosafety Level 3
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is Not AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 08MAR10

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Novasep Process - Pompey   5 mullti purpose DSP production lines
Location: Pompey, France
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is Not AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 02OCT12

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