All pharmaceutical facilities must meet a high level of construction and operational standards in order to be approved for pharmaceutical manufacturing.
Traditionally, ‘stick-built’ facilities have undergone extensive and expensive start-up and validation periods before achieving approval from the National Regulatory Authority.
Recently, the worldwide pharmaceutical industry is turning to modular pre-fabricated facilities that are built to international standards in well-equipped factories, shipped as completed modules to the manufacturing site and are then rapidly deployed, and prepared for regulatory inspectors. This approach is highly successful and greatly reduces the time required before manufacturing can begin and products can be sold.
KUBio is a prefabricated cGMP-compliant facility and process solution designed for the scalable and cost-efficient production of MAbs. Prevalidated modular units and processing equipment are transported to a site of your choice where they are assembled, and the resulting facility qualified, and ready-to-run within 14 to 18 months.