THE Industry Meeting Place to Exchange Real-World Solutions to Improve Speed, Cost and Quality
Conference: October 26-29, 2015 · Exhibition: October 17-19, 2015 ·
Concurrent Technology Workshops
Case StudyOptimal and Consistent Protein Glycosylation in Biosimilar Production
In the development of biosimilars, the biopharmaceutical industry is challenged with driving product quality toward equivalence with the innovative biotherapeutic. The consistent glycoform profile of biosimilars produced through large-scale cell culture is an important criterion that can dictate biological efficacy and ultimately regulatory approval. In addition, there is an increased interest in enhancing cell densities and product yields. This presentation will review advancements in glycosylation control in mammalian cell culture obtained through optimizing basal media, feeds, and process parameters. Case studies discussing recent optimization work utilizing the HyClone™ Metabolic Pathway Design process to, not only, improve product qualities, such as increased afucosylation or tri- and tetra-sialylated glycans, but also to increase cell density and enhance protein productivity, will be presented.
William G. Whitford, Senior Manager, Cell Culture, GE Healthcare
CQA Impurity Monitoring for Integrated Bioprocessing
This contribution proposes a novel approach using direct measurements of Critical Quality Attributes (CQA). We propose a CQA analyzer, which is based on a HPLC principle combined monolithic columns, which is used horizontally along the entire process, from upstream to downstream processing. Together with advanced multivariate data analysis algorithms, the chromatogram can be used as a fingerprinting method, allowing to track host cell impurities CQAs in a timely controlled way. Hence we present a PAT tool as per original definition.
Dr. Christoph Herwig, Professor of Biochemical Engineering, Vienna University of Technology, Austria
Technology Workshop with Light Continental Breakfast
Concurrent Technology Workshops
Case StudySingle-Use Fermentation: Understanding Process Economy and Process Performance
The entry of single-use bioprocessing and the benefits that come with disposables have generated interest in the microbial community. This talk will present results from a process economy comparison of fermentation scenarios based on stainless steel and single-use equipment. Additionally, data will be shown from a wet-work study of an E.coli domain antibody production using stainless steel and disposable equipment.
Kenneth Clapp, Senior Global Product Manager, Bioreactors, GE Healthcare
An Insight into Recent Developments in Protein A Chromatography
Protein A-based chromatography is the primary method used to purify MAbs. There has been a significant development of protein A chromatography media (resin), giving both higher capacity and improved stability to meet the changing requirements of the industry. More improvements are to come. We will provide some insights into the future plans of GE Healthcare's Life Sciences business for protein A media and our thoughts on what will be needed for the next generation of products.
Jonathan Royce, Senior Product Manager, Bioprocess Product Marketing - Downstream, GE Healthcare
Case StudyNew DataComparison of Methods and Materials for Single Use Bag Extractable Testing
This study highlights the relationship between two extractable test methods and the materials of construction of single use bag systems. The data show that the BioPhorum Operations Group (BPOG) protocol may not be sufficient as a single method for detecting extractables from single use bag systems, and that use of advanced materials like fluoropolymers allows more robust extractable detection methods.
Mike W. Johnson, Global Bioprocess Applications Manager for Life Sciences, Entegris, Inc