A quick intro to BioTechnique, a highly potent sterile contract manufacturer located in Madison, Wisconsin USA 53719. We make oncolytics, vaccines and nanoparticles. We look forward to hearing about your important project!
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BioTechnique is a new facility designed for filling cytotoxic and
highly potent sterile injectables.
Facility History
2008: Construction completed for Mentor Biologics.
2009: Mentor was acquired by Johnson & Johnson
PSC supported the validation work for the facility.
2014: PSC acquired the facility with the intent of operating as a
fill/finish CMO.
2015: BioTechnique facility is customer ready and BioTechnique
completes first project for a major charitable trust.
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The ModBioTechnique – Madison Facility & Expansion
Proposed Expansion Sites
Location:
5501 Research Park Boulevard,
Madison, Wisconsin, 53719
Total square feet of building:
• 37,400 sq. ft (14,000 is office
space)
• Current facility expansion plans
have potential of 80,000
additional sq. ft.
Site and utilities are designed for
future expansion which will increase
filling capacity and will include
additional lyophilization, filling, and
cGMP space.
Expansion would include both ISO 5
& ISO 7 cleanrooms.
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Equipment:
• Bosch fill line:
• Rotary vial washer
• HEPA filtered depyrogenation tunnel
• Filler with rolling diaphragm pumps and RABS system
• Capper with individual crimping station
• Edwards
• 144 sq. ft., 13 shelves lyophilizer
• Getinge
• Autoclaves (Getinge GE 600-cGMP/Lab)
• PennTech
• EVW-300 External Vial Washer
Facility Details - 5
Facility Details - 3
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• Water–for-Injection (WFI)
system (Mueller),
• Clean steam (Mueller)
• Reverse Osmosis/Deionized
(RO/DI) Water (Siemens)
• Oil-free, medical grade
compressed air system
(Ohio/Quincy)
• Chiller (Trane)
Facility Details - 4
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FDA labeler code: 70217
FDA FEI number: 3011856764
Regulatory Background:
• BioTechnique is registered with the FDA. We
are administered by the Minneapolis Field
Office.
• Pre-operational design review with FDA in
Summer 2015.
• BioTechnique Quality Department holds
regular departmental quality audits.
• FDA will not initiate an inspection of
BioTechnique until we enter commercial
production, expected 2017.
Regulatory History
