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10:15 10:45 11:15 Friday, October 12, 2012 (continued) Cell Culture Recovery & Purification Early Process Development and Cell Line Engineering Session Sponsored by: Early Process Development Integrating Chemically Defined Supplements and Feeds The choice of chemically defined media, supplements and feeds is a widespread decision these days. But it is not easy to predict the success of a new process based on historical results. Four case studies will show that choice of cell culture medium and supplement alone, or in combination, has an impact on protein production, cell metabolism, and potentially quality, including evidence of potential deamidation and N-linked glycosylation variants. Elizabeth C. Dodson, Ph.D., Manager, Research & Development, Advanced Bioprocessing, BD Biosciences Targeting Gene Expression Hot Spots in CHO Using UNPUBLISHED Engineered Meganucleases DATA Precision BioSciences has developed a set of engineered meganucleases that target the insertion of transgenes into well-characterized housekeeping gene clusters in the CHO genome. We show that cell lines produced by targeting transgenes to these gene expression “hot spots” express at a high level consistently over time without the need to pre-engineer a “landing pad” into the cell. Derek Jantz, Ph.D., Vice President of Scientific Development, Precision BioSciences Engineering Enhanced Cell Lines Using Zinc Finger Technology UNPUBLISHED Nan Lin, Ph.D., Cell Engineering, Cell Sciences and Development, DATA Principal R&D Scientist, SAFC 11:45 Technology Workshop Opportunities Available 12:15 Lunch on Your Own 1:25 1:30 2:00 Eliminating Bottlenecks – Impact of New Tools on Cell Culture Development Chairperson’s Remarks Charles Sardonini, Ph.D., Associate Director, Process Engineering/Development, Genzyme, a Sanofi company A Holistic Approach to High-Throughput Process Development Over the recent years there has been an increasing need for shortening development timelines for initial process development. At the same time it is required to generate a substantial more profound process understanding towards commercial processes. Boehringer Ingelheim has expanded its technologies around flexible small scale model systems and the corresponding miniaturized analytical methods spanning the entire process chain. The presentation aims to show how these successes will be also critical to success for pipelines expanding towards classical IgG molecules. Hitto Kaufman, Ph.D., Vice President, Process Science, Boehringer Ingelheim GmbH & Co., KG, Germany Developing Analytical Systems to Support CASE STUDY UNPUBLISHED High Throughput Bioreactors in Cell Culture DATA Cell line and process development play a major role in producing therapeutic proteins with high productivity and appropriate product quality attributes. To support this development, analyses of large number of samples generated from thousands of clones and process optimization are critical. Analyzing large number of samples has been a bottleneck in biotech industries because conventional analytical assays are low-throughput. Here we present various high-throughput (HTP) analytical platforms to facilitate rapid and parallel analyses of product quantity and quality using 96-well plate formats. These platforms include HTP protein quantitation followed by HTP protein purification and product quality analyses. With these analytical capabilities, we can assess product quality in the early stage of clone screening, as well as expedite the cell line and process development. Shashi Prajapati, Ph.D., Senior Scientist, Cell Culture Development, Biogen Idec Impact of Disposable Technologies and Flexible Platforms/ Manufacturing on Downstream Processing Development and Start Up of a Fully Disposable Facility CASE STUDY UNPUBLISHED DATA A Biogen Idec warehouse has been retrofitted for use as a disposable manufacturing facility. The repurposed facility utilizes a combination of existing traditional infrastructure to make cell culture media and chromatography solutions along with new disposable technology equipment to produce and purify clinical products. The disposable technology includes a cell culture suite with 1000 liter single-use bioreactors and two purification suites. This case study will cover the facility design, development of purification disposable process and successful start-up of the facility. Lynn Conley, Associate Director, Process Biochemistry, Biopharmaceutical Development, Biogen Idec A Case Study on a Process and Economical/Analytical Approach for Virus Filtation Step - Comparison of Stainless Steel and Disposable Virus Filtration Skids Peter Rogge, Director, Downstream Processing, Rentschler Biotechnologie GmbH, Germany Keynote Address Implementation of a QbD Approach for a Monoclonal Antibody Biologic License Application: A Downstream Purification Case Study CASE STUDY UNPUBLISHED DATA CASE STUDY UNPUBLISHED DATA A case study of a Quality-by-Design (QbD) approach to characterizing a Monoclonal Antibody downstream process will be presented. Discussion will focus on Risk Ranking and Filtering tools, scale-down models, criticality assessments, and unit operation/Design Space linking approaches. Tony Cano, Ph.D., Senior Engineer, Purification Development, Genentech, Inc. Developing Downstream Processes for Novel Molecules and Next Generation Protein Therapeutics Chairperson’s Remarks David W. Kahn, Ph.D., Director, Late-Stage Purification Development, Human Genome Sciences, Inc. Application of a Novel Affinity Adsorbent for the Capture CASE STUDY UNPUBLISHED and Purification of FVIII Compounds DATA Factor VIII (FVIII) therapies are used for the treatment of Hemophilia A, an inherited bleeding disorder caused by mutation in the FVIII gene. The development of a chromatography step that results in a product of high purity and yield is a major complexity. In this work, we describe the use of the VIIISelect, a commercially available affinity adsorbent. Following laboratory-scale process development, the VIIISelect was scaled up and used in the large scale manufacturing of a FVIII compound. Keith Selvitelli, Senior Associate Scientist, Process Biochemistry, Biogen Idec Finding Solutions to the Challenges of Developing a Platform Purification Approach for Domain Antibodies and Other Non-mAb Molecules UNPUBLISHED DATA The emergence of novel classes of antibody fragments creates new challenges for the development of standard downstream platforms. An approach that combines high-throughput and small column process development is presented in the perspective of early and late stage process development. Particular emphasis is given to the development of capture steps that can accommodate a variety of molecular scaffolds. André C. Dumetz, Ph.D., Investigator, GlaxoSmithKline Early Registration and Group Discounts are Available (see page 27) 20
2:30 Friday, October 12, 2012 (continued) Cell Culture Recovery & Purification 3:00 Networking Refreshment Break 3:30 4:00 4:30 Development and Integration of a Fully Automated High-Throughput UNPUBLISHED Platform for Cell Line Selection and Cell Culture Development DATA This presentation will identify the advantages of integrating, within a single system, fully automated process workflows for both cell line and cell culture development. Both the development and implementation of an in-house, customized automation platform and software tools for data analysis will be highlighted. Data will be shared to illustrate key features of the platform and the impact on cell line selection and characterization. Results will illustrate how this approach increased efficiency and allowed for the processing of multiple cell line screening and cell culture development projects in parallel. John Cesarek, Staff Automation Engineer, Five Prime Therapeutics Disposables in Cell Culture Disposable Implementation in Conjunction with High UNPUBLISHED Throughput and Automation Technologies DATA A strategy will be presented applying targeted automation tools to resolve resource constraints in upstream development. This includes automated spin tubes for the elimination of manual shake flask stages during clonal evaluations. Development of a 250mL single use prototype bioreactor for both mammalian and microbial cultures designed to be implemented in an automated platform with robotic sampling, feeding and independent control. Finally, disposable perfusion systems to intensify cell culture densities to enable high protein production will be shown. Rachel Bareither, M.S., Research Biomedical Engineer, Bioprocess Development, Merck & Co., Inc. Take II – More Findings and Updates on Our Experiences with CASE STUDY Disposable Bags for Cell Culture Media Storage UNPUBLISHED Dr. Masaru Shiratori’s presentation at the 2011 BPI Conference & Exhibition in Long DATA Beach, CA investigated challenges associated with specific disposable bags and usage conditions that resulted in reduced cell growth and product yield. In this presentation, we will provide updates on the ongoing investigation and give an in-depth review of our current understanding of the root-cause of the problem. Lessons learned and recommendations for selecting disposables for future applications will be shared. Joseph Wood, M.S., Engineer I, Process Development Engineering, Genentech, Inc. Co-Development of a New 2-D Rocking-type Single-Use UNPUBLISHED Bioreactor to Streamline Cell Expansion Processes DATA Co-development by an equipment vendor and an operating company of a novel 2-D rocking bioreactor is presented. The rocking mechanism enables high oxygen transfer rates and the single-use bioreactor bag is designed to have a wide range of working volumes, eliminating labor-intensive multistage cell expansion trains. The bag is also fitted with integrated single-use sensors to allow better control of cell culture conditions. Bert Frohlich, Ph.D., Director, Bioengineering, Process Development, Shire Human Genetic Therapies, Inc. 5:00 Close of BioProcess International TM Conference & Exhibition 2012 Novel Single-Use Method for Concentrating and Purifying Therapeutic Cells and Incorporating Process Analytical Technology in Downstream Processing CASE STUDY As cell therapy lot sizes increase to larger scales, it will be important to apply scalable bioprocessing concepts and technologies to therapeutic cell production. We have developed and characterized a scalable, closed system concentration and purification technology for therapeutic cell processing based on Tangential Flow Filtration (TFF). Examples will be provided where disposable and noninvasive sensor technologies are used to acquire real time data to make process decisions, enhance process knowledge, monitoring process performance and product quality. Jacob Pattasseril, Engineering Manager, Cell Processing Technologies, Lonza Developing Downstream Processes for Next Generation and Novel Molecules Utilization of Fluidized Bed Centrifuge Technology for UNPUBLISHED Cell Therapy Bioprocess Development DATA A fluidized bed centrifuge (FBC) was used to process cell culture harvests by concentrating and washing cells for cell therapy applications. In cell therapy bioprocess development, it is crucial to take into consideration the capability to concentrate cells to an efficacious target dosage, dictated by viable cell density, as well as reducing remnants of cell culture impurities such as serum to acceptable levels. By optimizing FBC process parameters such as flowrates and centrifugal force, results showed that the FBC is effective in separating cells from the supernatant to achieve the targeted cell density dosage and at the same time efficient in the removal of undesirable impurities. Overall cell loss during processing was minimal thus achieving a high cell yield from the FBC. Detailed results will be discussed in the presentation. Paul Ko, Ph.D., Research Scientist, Cell Technologies, Janssen Research & Development Design Space Around a Non mAb Complex Protein Therapeutic CASE STUDY One of the important quality by design (QbD) concepts is to establish a design space around a drug product. This presentation discusses the development of a design space UNPUBLISHED DATA around one of our non mAb complex protein therapeutics. The minimal concentration requirement for the protein therapeutic is 20 g/L. Protein charge profiles were identified as a critical quality attribute that will affect the protein solubility. An ion exchange (IEX) chromatography step in the downstream process was identified as a critical step that will impact the protein solubility. A design of experiment (DoE) study was performed to define a design space to control the protein solubility. First, a risk assessment (FMEA) was performed to rank the process parameters in the IEX step. Second, the high risk parameters were screened by a high throughput screening (HTS) platform using Atoll Mini-columns. The significant parameters that might impact protein solubility, recovery, and impurity clearance were identified. Third, the significant parameters were further studied by scale down column runs to define a design space. Finally, a process control strategy was developed based on the DoE study results to better control the process performance and product quality. Yiming Yang, M.S., Senior Scientist, Purification Process Development, Shire Human Genetic Therapies, Inc. Development of an Integrated Protein UNPUBLISHED Reduction/PEGylation Platform DATA PEGylation has been shown to improve therapeutic protein half-life. A reduction and PEGylation process is optimized for a complex therapeutic protein to minimize by-product. The PEGylation efficiency is dependent of reductant and PEG concentrations as well as incubation time. The process is successfully incorporated into a scalable integrated platform where the entire reduction/PEGylation process is performed in a single unit operation. Brian To, Ph.D., Senior Staff Development Scientist, Isolation and Purification, Bayer HealthCare 21 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI
Page 1 and 2: "A must-attend conference every yea
Page 3 and 4: The world’s largest gathering of
Page 5 and 6: Agenda-at-a-Glance -With So Much Go
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Page 9 and 10: 10:15 10:45 11:15 Enhancing Manufac
Page 11 and 12: Achieving Rapid Process Development
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Page 23 and 24: Meet the People Behind the Products
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Page 27 and 28: Two-Day Training Courses: Combine i

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