CSS - Agenda
2016 Technology Workshops
2016 Technology Workshops
Tuesday, March 15, 2016
Concurrent Technology Workshops
Case StudyDevelopment of Early Stage Therapeutic Antibody Candidates
Development of a therapeutic monoclonal antibody (mAb) candidate is a complex, multistep and interconnected process. In this workshop, through case studies, we will demonstrate how technologies constructed on a chemically defined CHO medium platform can be used to facilitate development timeline in taking a therapeutic mAb from discovery through early stage development and toward becoming a feasible clinical candidate.
David T. Ho Ph.D., Senior Scientist II, Irvine Scientific
Yves Durocher Ph.D., Research Officer, National Research Council Canada
In the Quest for an Optimized Upstream Bioprocess - Are We There Yet?
Ever increasing biopharmaceutical market demands for enhanced efficacy have driven the interest in continuous cell culture process development and optimization. With dramatic advancements in the areas of cell lines, culture media, and processes; upstream bioprocessing has seen a shift in development focus over the past decade. The early efforts concentrated on overcoming productivity bottlenecks to establish economic process viability and logistic feasibility. These efforts have resulted in titer improvements from mg/L to g/L. With current availability of high-performing, off-the-shelf commercial cell culture medium platforms that can eliminate titer constraints, the focus has switched towards product quality. Critical quality attributes, such as glycosylation profiles, product aggregation, and charge variants have become frequent targets of medium and process optimization. Case studies are presented to summarize some common strategies that have been used to address product quality concerns. Moreover, there is an emerging trend for adopting continuous manufacturing in bioprocessing. Proof of concept studies that demonstrate feasibility of intensified perfusion cell culture and its implication on product quality will also be discussed. The results will provide insight in the direction of next-generation upstream bioprocessing.
Nan Lin, Cell Culture Process Application Leader, GE Healthcare
Optimization of a Specific Enzyme Conversion Step to Generate High-Titer, Fully Processed Antibody in CHO Cells
Toward Continuous in Upstream and Downstream Processing
Continuous processing yields process efficiencies, the ability to manufacture more biotherapeutic with less resource. On the upstream side, cell culture with the ATF System cell retention device drives significant efficiency in multiple cell culture workflows. And in downstream processing, utilizing OPUS pre-packed chromatography columns drives efficiency in manufacturing readiness and enables continuous chromatography approaches.
Christine Gebski, Vice President Product Management and Field Applications, Repligen Corporation
Factors to Consider for Selection of an Auto-Sampling Technology and Process Management Systems with Roche Cedex Analyzers: Flownamics and Bend Solution, links in Bioprocess Automation with Cedex Analyzers
The Seg-Flow 4800 Automated On-Line Sampling System from Flownamics and Bend Research Modular Automated Sampling Technology otherwise known as MAST provide multiple bioprocess monitoring and control solutions for improving process performance. The Cedex Bio HT systems are designed to deliver the testing accuracy, system reliability, and operational efficiency needed for the bio-manufacturing processes. This workshop presents key factors that can impact data quality and speed to simultaneously acquire, integrate and centralize process data from multiple in-line, on-line and at-line analytical instruments.
Clint Pepper Ph.D., Director, Bend Research
Ashely Fisher Kapp, Product Manager, Flownamics
Wednesday, March 16, 2016
Technology Workshop with Light Continental Breakfast
Evolving Current mAb Purification Platforms: How the Sum of Small Changes Can Lead to Big Steps Forward in mAb Production
MAb purification platforms allow efficient processing, from process development to manufacturing of final product. Continuous platform improvements are necessary to meet demands for enhanced process efficiency. New tools with improved features are introduced. This presentation will show how small process changes can offer significant advantages and provide insights into recent technology developments in the field of MAb purification platforms.
Sofie Stille, BioProcess Media Business Leader, GE Healthcare
Concurrent Technology Workshops
Technical Considerations in Developing a New Plastic Film for Single Use Technologies
In the past decade, single-use systems have gained wide acceptance in biopharmaceutical manufacturing. With single-use bioreactors increasingly used in clinical trials and commercial production; their quality, reliability, and security of supply become more critical. This presentation focuses on the technical aspects of plastic films used to construct single-use bioreactor culture bags, which are essential for a robust performance in bioprocess applications.
Susan Burke, Ph.D., Material Science Leader, GE Healthcare
Case StudyNew DataHost Cell Protein Assays - New Tools for an Ongoing Challenge
Immunoassays are the workhorse for host cell protein quantitation but also have certain challenges associated with them. This case study shows a holistic approach to address these challenges starting with conditioning of the antigen, alternative immunization models (e.g., chickens) and the use of state-of-the-art orthogonal methods such as mass spectrometry and peptide immunization.
Olaf Stamm, Ph.D., Senior Specialist Biological Testing Solutions, Charles River
Thursday, March 17, 2016
Faster to Market: Case Studies on Successful Technical Transfer, Manufacturing and Support Utilizing Single-Use Systems and Flexible and Deployable Manufacturing Platforms
The biomanufacturing industry is challenged with aggressive timelines, while still reducing risk and cost. This presentation will explore case studies of how success has been achieved through working with a global service and technology provider focused on building strong relationships, supporting streamlined technical transfer strategies, conversion from stainless steel to single-use systems, and utilization of flexible and deployable manufacturing platforms.
Joe Makowiecki, Global Technical Manager, GE Healthcare Life Sciences