Tham khảo tài liệu 'innovations in biotechnology part 16', kỹ thuật - công nghệ, cơ khí - chế tạo máy phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | Monoclonal Antibody Development and Physicochemical Characterization by High Performance Ion Exchange Chromatography 441 advanced antibody engineering technologies almost all antibody products currently in development are humanized or fully human mAbs and their derivatives. 3. Monoclonal antibody production Recombinant monoclonal antibodies are typically produced in mammalian cell lines under defined cell culture conditions. Commercial scale production processes vary depending on the mAb but generally cells are taken from a master cell bank and inoculated into smallscale bioreactors. The cell culture is transferred to increasingly larger bioreactors until it reaches the final commercial scale bioreactor. Currently final scale reactors have volumes ranging from 12 000 L to 24 000 L Gottschalk 2009 . The cells are cultured in a controlled environment for days to weeks and then the cell culture fluid is harvested by centrifugation Shukla Kandula 2008 . In mammalian cells the product monoclonal antibodies are secreted from the cells into the supporting fluid medium. Centrifugation separates the cells from the fluids and facilitates simpler recovery procedures downstream. Commercial mAb production requires considerable preproduction effort to ensure that the cell line is stable and can produce commercially appropriate quantities of antibody. In addition the commercial production process must produce a product that meets the quality expectations of regulatory authorities. In the past few years improvements have been made in critical areas such as cell line generation and large-scale cell culture production to maximize specific antibody productivity from a given cell line and improve overall productivity in bioreactors. These advances include the use of new expression vectors and transfection technology high-throughput robust screening technologies to select the highest producing clones rapidly and more effectively improvements in cell culture and optimized bioreactor .
