This preliminary program is subject to change.

Bioseparations / Downstream Processing of Biopharmaceuticals


Description:
Separation unit operations make up a critical portion of biologics downstream processes. Complexity inherently associated with biologics manufacture such as product heterogeneity and host cell impurities presents process challenges not typically encountered in small-molecule separations. With bioreactor titers increasing steadily over the last several years, production cost and operational pressures are shifting further to downstream. In addition, biological metabolites are still produced in relatively low amounts. The development of cost- and time-effective bioseparation and concentration unit ops is thus key to efficient downstream processes. This session focuses on highlighting the latest advances in bioseparations and downstream processing, aimed at cost reduction, improved efficiency, and shortened development time. Topics to be covered include, but are not limited to: Centrifugation, Filtration, Crystallization, Extraction, Precipitation, Membrane-based Separation, Adsorption, Ion exchange and Expanded-bed chromatography as well as other Chromatographic Modes.

Sponsor:
Pharmaceuticals


Chair:
Nuno Fontes
Senior Engineer, Late Stage Purification
Genentech, Inc.
Late Stage Purification
1 DNA Way MS75
South San Francisco, CA 94080
Email: fontes.nuno@gene.com

Co-Chair:
Jose Cardoso Menezes
Research Center Pharmaceutical Engineering GmbH
Graz 8010
Fax Number: (+351) 21 841 9197
Email: cardoso.menezes@ist.utl.pt


Papers:
Ligation-Independent Cloning with Self-Cleaving Intein As a Tool for High-Throughput Protein Purification
Tiana D. Warren, The Ohio State University; Michael J. Coolbaugh, The Ohio State University; David W. Wood, The Ohio State University
Combination of Spectroscopic Methods for Inline Monitoring and Control of Mammalian Cell Cultivations
Stefan Buziol, Roche Diagnostics GmbH; Roman Greppmair, Roche Diagnostics GmbH; Rainer Mueller, Roche Diagnostics GmbH; Pedro Felizardo, 4Tune Engineering Ltd - Technology Services & Products; Joana Mendes, 4Tune Engineering Ltd - Technology Services & Products; Jose Menezes, Research Center Pharmaceutical Engineering GmbH
Towards a Next-Generation Harvest Strategy for Monoclonal Antibody Processes: Cost Considerations and New Technology Evaluation
Michael Felo, EMD Millipore Corp.; Nripen Singh, EMD Millipore Corp.; Neil Soice, EMD Millipore Corp.
Role of Intermolecular Interactions On Ultrafiltration of Pegylated Proteins
Krisada Ruanjaikaen, Pennsylvania State University; Andrew L. Zydney, The Pennsylvania State University
Challenges of UF Optimization for High Concentration Therapeutic Proteins
Sunitha Kandula, Merck &Co; Pragathi Peddi, NJIT; Edward Glowacki, Merck & Co.; Thomas Linden, Merck & Co., Inc.