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 StudyOptimized 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, Sr. 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
Mechanical Stress in Standard and Single-Use Pumps Using Cell- and Particle-Based Stress Analysis
The development of shear sensitive pumps is necessary to avoid cell or even product damage in the biopharmaceutical industry. In this study, the mechanical stress acting on cells, proteins and an emulsion were determined for commonly used pumps (e.g. peristaltic and diaphragm pumps) and compared to an alternative pump technology - the magnetically levitated centrifugal-pump (MagLev pump). For these investigations, the MagLev pumps caused lower mechanical stress on cells, proteins and emulsion drops compared to their counterparts.
Ina Dittler, MSc. Research Assistant, School of Life Sciences and Facility Management, Zurich University of Applied Sciences
The Future Journey from Molecule to Commercial Production
Perhaps the not so distance future of biodevelopment and production will have significantly reduced clinical development timelines, flexibility when utilizing single use technologies such as direct scalability, closed upstream processing, and continuous downstream options, as well as the ability to implement local production facilities on a global basis. The past decade has been one of rapid growth and change for single use technologies and they are establishing their identity within biopharma. And technology in general, the principle driver of globalization, has made the world larger in terms of access to emerging markets. This presentation will discuss the potential future state for processing using single use technologies as well as accelerated biodevelopment and deployment of these production facilities on a global basis.
Sue Walker, Provantage End-to-End Solutions, Merck Millipore
Integrate, Acquire, and Centralize In-Process Data from Roche Cedex Analyzers: Overview of Auto-Sampling Technologies from Flownamics and Bend Research and Data Management Solutions from Musa
Paul Strand, Application Engineer, Flownamics
Ali Yeyinmen, Product Manager, MUSA
Clint Pepper Ph.D., Bend Research
Technology Workshop with Light Continental Breakfast
Simplify and Intensify: Solutions for Cell Culture Process Intensification
Transformative cell culture technologies will be reviewed. The award winning ATF cell separation device enables process intensification and continuous processing, allowing for smaller bioreactors and smaller facilities in more locations. Media plays a key role in perfusion, the leading application for ATF, where addition of LONG®R3 IGF-I cell culture supplement boosts productivity significantly because it is 200 times more potent than insulin.
Millie A. Ullah, Ph.D., Associate Director, Product Management & Marketing, Repligen
Concurrent Technology Workshops
Case StudyUsing Process and Activity to Drive Clone Selection
During a manufacturing cell line development project in stable CHO-K1 cells, a significantly reduced specific activity of target protein was observed when compared to a reference standard. This case study highlights how the lack of activity was identified and how the development of an optimized cell culture process enabled identification of high productivity clones.
Oren E. Beske, Ph.D., COO, Aragen Bioscience, Inc
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.
Henrik R. Ihre, Ph.D., Director Custom Design Media, GE Healthcare Life Sciences
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
Case StudyNew DataIntroducing Amsphere A3: The Relationships and Considerations of Bead and Pore Structure, Surface Chemistries, and Ligand Design on Affinity Resin Performance
Industry needs, patent expirations of ligand design and market dynamics have accelerated the development and availability of many protein affinity resins. Technology providers must consider a range of design parameters such as resin backbone, bead size, pore size, surface chemistry modification, ligand construct and how they relate to performance criteria such as DBC, life time, caustic stability, and column packing among others. JSR's approach to designing Amsphere A3™ affinity resin will be discussed. The balance between resin design and resin performance will be illustrated through a case study.
Marty Siwak, Director, Separation Science Group, JSR Life Sciences
Zhuo Liu, Ph.D., Scientist, KBI Biopharma, Inc
Increasing Protein Production with Novel Cell Ess Supplement without Affecting Metabolic Profile
Enhancing protein production is a common bioproduction goal. At a concentration of 1% Cell Ess supplement resulted in a 37% increase in productivity. Used as a feed, it resulted in a 25% increase in yield and extension of peak protein production. Our results suggest than an increase in protein production may not require a change in the metabolic state of the cells.
Adam Elhofy, Ph.D., CSO, Essential Pharmaceuticals
Delivering process and cost efficiencies for early clinical and biosimilars production with ProcessReady Columns
Time and cost pressure are significant for biosimilar producers or in early clinical phase production. The selection of highly productive, cost-effective resins for DSP is critical. The addition of ready-to-use formats to such a campaign can enhance process intensification and drive greater cost efficiencies. This workshop will present a platform process with ProcessReady™ columns from Purolite, pre-packed with Praesto™ affinity and ion-exchange resins.
Chris Major, MSc., Director of Agarose and Bioprocessing, Life Sciences, Purolite
Significant Technology Advances Enable Integrated Continuous Bioprocessing
An overview of cutting edge technologies supporting the adoption of continuous downstream processing will be provided. These technologies include BioSMB (R symbol) multicolumn continuous chromatography and Cadence (trademark symbol) Inline Concentrator. Pall has an exclusive license for acoustic wave separation (AWS), a disruptive technology from FloDesign Sonics for cell culture clarification applications. AWS complements Pall's industry-leading STAX(trademark symbol) depth filtration products to enable continuous clarification of cell culture.
Michael Egholm, Ph.D., V.P. and General Manager, Pall Biopharmaceuticals, Pall Biopharmaceutucals Division, Pall Corporation