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