Implementation of new high potent drug product production unit
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Client: Confidential
Location: Belgium (North)
Completion: 2019
Total Investment Cost: Confidential
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Implementation of new High Potent Drug Product Manufacturing unit in an existing facility.
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Concept study, Basic and Detailed Design, Procurement, Construction Management and Commissioning/Qualification.
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HVAC, Clean Rooms Finishes, Utilities, Electrical, EMS and integration of Isolator technology.
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Commissioning & qualification of new viral vector production unit
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Client: Novasep
Location: Belgium (South)
Completion: 2019
Total Investment Cost: ca. 27m€
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Implementation of new Green Field Viral Vector Production facility, including 2 cGMP production units. One unit is dedicated to adherence cell culture for viral vectors in moderate quantities (to treat certain rare diseases or for lower dose indications and one unit for suspension cell culture with bioreactors up to 2000L to produce larger quantities.
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Commissioning and Qualification (including project qualification strategy, URS, Risk Analysis, FAT, SAT, IOPQ, CSV).
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Utilities/ Facilities: HVAC, Purified Water production and distribution, Clean gasses (Compressed Air, CO2, O2, N2) production and distribution
Process Equipment: Bioreactors, Clarification skids, (Ultra)filtration skids, chromato skids, buffer prep skids
Automation: AMS, EMS, Interlocking
Support Equipment: Decontamination System, Decontamination autoclave, Sterilisation autoclave, LAF cabinets, Biosafety Cabinets
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