Continuous Processing In Pharmaceutical Manufacturing.pdf
With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.
Dr. Ganapathy Subramanian is a biotechnology consultant with over 30 years experience in industry and academia, encompassing the application and development of processing, purification methodologies, and chromatographic systems for largescale use in environmental science, food science, perfumery, cosmetics, and pharmaceuticals. He has also taught extensively in the area of food and medical technology. A chemistry graduate from Madras, India, Dr. Subramanian was awarded his doctorate, from the University of Glasgow, for work on natural products. His main research interests lie in the utilization of natural material separation processes and bioconversions. Dr. Subramanian has written and edited a number of books and articles in the field of biotechnology. For the last 15 years, he has been organizing conferences promoting the integration and sharing of knowledge between academia and industry.
Continuous production of bacteriophages Simulated moving bed, expanded adsorption and continuous ion exchange process in downstream processing Continuous Flow Manufacturing in downstream biologics Continuous and single-use technologies to establish a new downstream processing platform for monoclonal antibodies Continuous perfusion processes for mammalian cell cultures The Review of Flexible Production platforms for the future BioSMB technology as an enabler for a fully continuous disposable biomanuafacturing platform mAB continuous processing enabled by single use Perfusion process design in a 2-D rocking single-use bioreactor Multicolumn countercurrent gradient chromatography for the purification of Biopharmaceuticals Opportunities and Challenges for the Implementation of Continuous Processes to Biomanufacturing Implementation of CQA (Critical quality attributes) based approach for Development of Biosimilars Optimization of Continuous Downstream Process in Biopharmaceutical Manufacturing Automated single-use centrifugation solution for diverse biomanufacturing processes Evaluating the economic and operational feasibility of continuous processes for monoclonal antibodies The Potential Impact of Continuous Processing on the Practice and Economics of Biopharmaceutical Manufacturing Very high cell density in perfusion of CHO cells by ATF, TFF, Wave bioreactor and/or CellTank technologies - Impact of cell density and applications Advances in the application of perfusion technologies to Drosophila S2 insect cell culture Single-use Systems Support Continuous Bioprocessing