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Recent projects where V2 Bio-Consulting has provided excellent client service:

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  • Assisted in the start-up, commissioning and validation of a new 100,000 sq. ft. large-scale cell culture production, filling and lyophilization facility.  Project included preparing the facility and organization for first cGMP production runs.  Assisted in preparing BLA for submission and associated PLA.

  • Provided operational and facility design reviews and developed associated SOPs for new GLP/GMP production and fill facilities.

  • Project managed the validation and licensure of BOC Edwards lyophilizer.  First of seven commercial products was licensed in December 2005.

  • Project managed the completion of production facility and labs to fill insulin for pulmonary delivery system.  Negotiated 3rd party agreement to package and ship product.

  • Prepared company for licensure of first product including PLA.  Audited CMOs and assisted in process validation and writing of CMC sections.