Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.
Issue link: http://gen.epubxp.com/i/695748
Genetic Engineering & Biotechnology News | GENengnews.com | JULY 2016 | 27 allel with preparation of the greenfeld site. FlexFactory biomanufacturing platform also uses disposable, single-use technologies, eliminating cleaning validation steps, and pro- viding signifcant time and cost savings. It is also easier to switch production from one ther- apeutic to another quickly between batches. The modular and standardized nature of KUBio also makes future expansion of the facility easy to implement, just by adding an- other KUBio, which can also be replicated at any number of sites in different locations, linked through a single automation platform to provide a global network of KUBios. GEN How will working in such a modular factory improve a company's product development and biomanufacturing activities? Mr. Makela The GE FlexFactory installed in the KUBio brings together bioprocessing equipment from the early stages of cell ex- pansion all the way through to the down- stream chromatography steps. The FlexFac- tory comprises technologies such as mixers, bioreactors, fltration and chromatography systems which are integrated through a sin- gle automation platform (such as Wonder- Ware or DeltaV). FlexFactory provides the fexibility to scale-up from process development to com- mercial production, and is capable of sig- nifcant production capacity within a small footprint. The KUBio just opened at JHL Biotech's site in China will be used to manu- facture up to 100 kg of monoclonal antibod- ies per year in 2,000 L single-use bioreactors. Initially, four 2,000 L bioreactors have been installed. The facility is a two-story building with a footprint of roughly 1,200m 2 , includ- ing manufacturing space as well as heating, ventilation, air conditioning, and storage. This output capacity is outstanding for the industry and exemplifes how manufacturers and equipment suppliers are working togeth- er to drive up the effciency and productivity of the manufacture of biopharmaceuticals. The process control system allows the user to monitor, control, and respond to the real-time performance of the manufacturing process from a number of positions through- out the facility, united with one user interface for simplicity. GEN Are there any diferent and specifc GMP guidelines that companies need to be aware of in working in this type of facility? Mr. Makela The facility is prequalifed to a cGMP-compliant standard and the stan- dardized nature of the facility also means that applications for drug approvals are simplifed. GE Healthcare handles all ap- provals with authorities so that the only responsibilities of the customer are the acquisition of the site, getting the appro- priate permissions, and preparing it for the KUBio, along with some supporting infra- structure required for the full site set up. GEN Are there other announcements coming soon about additional place- ment of the KuBio modular factory? Mr. Makela GE is now building another KU- Bio (the purchaser has not yet been publicly announced) and is discussing project oppor- tunities in such countries as Brazil, Mexico, South Korea, and Saudi Arabia, among oth- er places. Serving All Your Life Cycle Needs Pharma&Biotech; www.lonza.com Lonza's Peptide Experts Provide Total Life Cycle Management from Feasibility Studies through Commercial Supply Lonza recognizes the importance of starting with the right materials and maintaining stability of supply through every phase of the product life cycle. Partner with us for reliable custom peptides at every stage, and every scale. – Early Intermediate (GMP, non-GMP) – Development technology services for solid and liquid phase synthesis – Advanced Peptide Intermediates – Bulk Actives / Drug Substance – Generic Peptides peptides@lonza.com North America +1 201 316 9200 Europe +41 61 316 8111 JHL Biotech and GE Healthcare partnered to assemble a cGMP-compliant biomanufacturing facility in just 18 months. Speedy assembly was possible because JHL opted to use GE's KUBio solution, which consists of prefabricated modules. The facility, which is located in China, incorporates single -use technology and is designed to produce biosimilars and monoclonal antibodies. Perspectives BIOPROCESSING caption