Norwegian Institute of Public Health

The Biopharmaceutical production department of Norwegian Institute of Public Health offers GMP services including manufacturing, QC and release of investigational and licensed medical products.

Our Products & services includes:

  • Manufacturing of (bio)pharmaceuticals and medical devices
  • Manufacturing of vaccines and therapeutic drugs
  • Aseptic processing 
  • Warehousing and supply of products for clinical trials and for commercial sale
Our facilities and systems are designed for safe handling of infectious materials and/or GMM's according to Biosafety class 3 standards.

Our specific services are:

  • Cultivation of bacteria, viruses and cells
  • Formulation and blending
  • Aseptic filling and terminal sterilization
  • Quality Control services
  • Release for clinical trials and for commersial sale
  • Validation
  • Process scale-up and tech transfer
  • Development of manufacturing process and control methods
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Locations


Norway
Norwegian Institute of Public Health
Lovisenberggata 6
Oslo,   N-0456
Norway, Europe

GMP Experience
Authorised for Manufacturing operations of 1) Human investigational Medicinal Products 2) Human Medicinal products

Contacts


Truls Simensen
Director CMO Department

Production Lines

Norwegian Institute of Public Health   Biopharmaceutical up- & downstream
Location: Oslo, Norway
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Scale:  1L-100L100L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 3Biosafety Level 3
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is Not AvailableCell Banking
Cell Line Development is Not AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 19SEP12

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Norwegian Institute of Public Health   Fill/Finish
Location: Oslo, Norway
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
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 AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are AvailablePrefilled Syringes
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 07JUN10

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