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 ·
Cell Culture & Upstream Processing
Cell Culture & Upstream Processing
Cell Culture & Upstream Processing
Process development scientists, engineers and technical experts share their recent achievements in reducing timelines and COGs while increasing efficiency and productivity through implementation of disruptive approaches and technologies across all stages of cell culture.
Registration and Coffee
Susan Dana Jones, Ph.D., Vice President and Principal Consultant, BioProcess Technology Consultants
Optimizing Interface with Discovery and Applying 'Omics and Systems Biology
High-Throughput Multi-Parametric Clone Screening Approach for the Generation of Tailored Production Cell Lines
Trent Munro, Ph.D., Principal Scientist, Process Development, Amgen
Next Generation Sequencing to Support CHO Cell Line Development
Stephanie Rieder, Ph.D., Principal Scientist, AbbVie
Case StudyNew DataTranscriptomics of CHO Pipeline Clones with Respect to Inherent Bioprocess Properties
The transcriptome analysis of CHO production clones with known differing bioprocess properties (>120 clones, similar cell age/condition) is described. The transcripts data were initially filtered based on the Principal Component Loadings (PCA), analyzed by linear regression and by Multivariate Data Analysis (PLS). The results are used as CHO specific functional annotation for future experiments/ interpretation and for "cell line diagnostics".
Wolfgang Budach, Ph.D., Lead Late Phase Process Development, BPRD, Novartis Pharma AG, Switzerland
New DataSystems Biology - From Improving Expression to Understanding GenomicHeterogeneity and Stability
In recent years, researchers have aimed at improving cellular performance by obtaining an enhanced understanding of cellular mechanisms using different -omics analysis tools. Recent data on DNA methylation, epigenetic regulation and genomic diversity in CHO cells lines highlight the ongoing genomic changes during cultivation and cell line development and the necessity to design engineering approaches by taking into account individual clonal requirements.
Nicole Borth, Ph.D., Professor, Department of Biotechnology, BOKU University Vienna, Austria
Networking Refreshment Break
Applying Novel Approaches and Tools to Cell Line Engineering and Development
Case StudyNew DataA Comprehensive Comparative Study Between DG44 and GS-KO Cell Line Generation Platform
Lianchun Fan, Ph.D., Senior Scientist II, Bristol-Myers Squibb
Case StudyBundling of Cell Line and Vector Technologies to Improve Expression, Stability and Timelines
Thomas Jostock, Ph.D., Senior Fellow, Novartis Leading Scientist, Biologics Technical Development & Manufacturing, Novartis Pharma AG, Switzerland
Case StudyNew DataApplication of CRISPR/Cas9 Technology to Improve Cell Line Development and Production
With the recent emergence of CHO genome sequences, CHO cell line engineering has taken on a new aspect through targeted genome editing. Facile genome editing using the bacterial RNA-guided CRISPR/Cas9 technology empowers researchers in the CHO community to elucidate the mechanistic basis behind high level production of proteins and product quality attributes of interest. Here, I will present the application of CRISPR/Cas9 technology for development of next generation CHO cell factories mainly focusing on knockout and knock-in approaches while highlighting both future perspectives and challenges.
Jae Seong Lee, Postdoc, Ph.D., The Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark
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
Chandana Sharma, Ph.D., Principal Scientist, Cell Sciences and Development, SAFC
New DataModeling of Glycosylation - Predicting Profiles of Glycosylation from Metabolic Data
Single glycoform monoclonal antibodies can be targeted for specific therapeutic functions. The glycosylation profile can be controlled by cellular glycoengineering, media manipulation or enzymic re-modelling. Possible strategies for the use of each of these methods will be shown for the production of an antibody. The expected outcomes of such strategies will be evaluated with specific examples of commercial mAbs.
Michael Butler, Ph.D., Professor of Microbiology, University of Manitoba, Canada
Integration of Automated Data Management Systems and Process Analytics
The Benefits of Applying Automated Data Management Systems to High-Throughput Clone Screening Experiments
New high-throughput culture techniques allow for an expansion of the scope of mammalian clone screening experiments to include process development parameters. The resulting data sets are larger and demonstrate new data management challenges. Uploading the process data to a database linked to analysis tools overcomes the data analysis bottleneck and allows for effective translation of complex data into faster decision-making.
Brandon Moore, Cell Culture Engineer, Technical Development, Biogen
Case StudyNew DataRaising the Bar: Advanced Analytics in Upstream Bioprocess Development
Advanced analytics result in identification of low level product related variants, many are previously undetected. Examples will be given on the identification and quantification of low level variants during cell line and cell culture process development. Improved understanding of upstream bioprocess and its impact on product quality pushes the frontier in safe, consistent and appropriately regulated biopharmaceutical production.
Christopher Yu, Ph.D., Senior Scientist, Protein Analytical Chemistry, Genentech, A Member of the Roche Group
Short Break to Move to Keynote Session
Innovating mAb Production to Support the Immunotherapy Revolution
A new paradigm in cancer therapy is emerging with the recent success of the antibody mediated, immune tumor killing response for melanoma. Evaluations have expanded to include a range of tumor types. In addition new alternatives and combinations are aimed at improving patient non responsiveness to PD-1. These foundational efforts of emerging cancer treatment need to be supported by agile antibody supply solutions that meet the capacity demands, while improving global access and lowering costs. Technology solutions have been implemented to speed process development and shorten the critical time to first in human clinical studies. Innovative approaches towards the 'process of the future' will be shown that support flexible multi product lower cost manufacturing. Continuous processing enabled by single use provides an integrated solution and the implementation challenges will be discussed.
David J. Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co. Inc.
Innovative Process Development Strategies to Drive the Rapid Clinical Introduction of Emerging Biologics
The movement of a large portfolio, consisting of a broad spectrum of biological molecule-modalities, requires seamless integration from the research bench to the clinic. Deep alignment and partnership between the Research and the Process/Analytics functions allows for rapid and systematic product candidate screening, eliminating the most problematic candidates. Combining state-of-the-art cell lines with a regimented application of robust high-throughput process and analytical development packages enables record speeds to the first patient with minimal resources.
Spencer Fisk, Global Head, Biologics Process R&D, Novartis Pharma AG, Switzerland
Novel Approach to Developing and Producing Human Experimental Vaccines for HIV
Michael Anthony (Tony) Moody, M.D., Chief Medical Officer, Associate Professor of Pediatrics, Duke Human
Trick or Treat! Halloween Reception and Exposition Hall Grand Opening
The opening night reception sponsored by Roche will feature a Halloween theme complete with a fun and festive ambiance. Come and enjoy Halloween-inspired food, drinks, decorations and games while networking with exhibitors, poster presenters and other attendees in the exposition hall.
Registration and Coffee
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
Amgen's Next-Generation Biomanufacturing Facility
Described here is the establishment of a biomanufacturing platform for the production of biologic medicines. Competitive product portfolios that can respond quickly to changes in market dynamics have necessitated optimization of production strategies. The "Next-Generation Biomanufacturing" platform allows for fast and flexible drug operations for synthesis of drug substance in a reconfigurable manufacturing system. Key enabling technologies include modular construction, single-use bioreactors, disposable plastic containers, continuous purification processing and real-time quality analysis. Amgen's Next-Generation Biomanufacturing changes the way we will manufacture in the 21st Century.
Kimball Hall, Vice President Manufacturing, Amgen Singapore Manufacturing Pte. Ltd.
What is the Future of Continuous Processing - What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme
Chandana Sharma, Ph.D., Principal Scientist, Cell Sciences and Development, SAFC
Development and Production of New Modalities
Wacker Biotech Refolding Technology - The Complement to ESETEC® Secretion Platform
Nicole Peuker, Ph.D., Scientific Specialist, Bio Process Development, Wacker Biotech GmbH, Germany
New DataEmulsification Process to Alginate Encapsulate Cells for Diabetes Therapy
James M. Piret, Ph.D., Professor, Michael Smith Laboratories & Dept. of Chemical and Biological Engineering, University of British Columbia
Case StudyNew DataDevelopment of a Scaleable and Productive Insect Cell Culture Based Process for Making Flublok, The First FDA Licensed Recombinant Influenza Vaccine
The hemagglutinin (HA) protein from the Influenza Virus has proven to be an effective vaccine. This presentation will demonstrate that the manufacturing process is reproducible and scaleable. An example is presented (for H7N9) on how the HA based vaccine process used to make Flublok by Protein Sciences is an ideal manufacturing platform for rapid response to pandemic influenza.
Barry Buckland, Ph.D., Senior Advisor, Protein Sciences
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
Networking Luncheon in the Exposition Hall
Roman Rodriguez, Senior Product Marketing Leader, Upstream, GE Healthcare Life Sciences
Perfusion and Continuous Processing in Cell Culture
Case StudyNew DataMitigating Scale up and Process Challenges for a High Cell Density CHO Perfusion Process in Single-Use Bioreactors
A high cell density perfusion cell culture process utilizing a CHO cell line was developed in a 10L laboratory scale bioreactor. The process was scaled up to 200L and 2000L single use bioreactors to enable the pre-clinical and clinical production of a recombinant protein. Challenges encountered during the development, scale up and tech transfer, such as cell retention device, mass transfer, mixing, shear stress, and centrifuge perfusion capacity will be discussed.
Hang Yuan, Ph.D., Associate Director, BioProcess Development, Shire
Case StudyNew DataHigh-Yield Production of Biologics Enabled by Perfusion and Intensification Process
Hao Chen, Ph.D., Director, Process Development & Engineering, Merck & Co., Inc.
Points to Consider for Commercial Continuous Bioprocessing
Over the last 30 years, a number of biologics have been commercially licensed that are produced by continuous bioprocessing for some portion of the production line. Today, continuous bioprocessing is being considered by more firms for development stage products and processes for a different set of industry trends, drivers and opportunities. This presentation will review the new drivers and opportunities as well as unforeseen points to consider for the commercial licensure of continuous bioprocessing.
Parrish Galliher, M.S., Chief Technology Officer, GE Healthcare
What is Driving Improvements in Efficiency, Productivity and Timelines in Cell Culture
Case StudyNew DataAccelerating Time to Clinical Manufacturing Following a TargetedGene Integration Approach
Dethardt Mueller, Ph.D., Head of Process Science, Rentschler Biotechnologie, Germany
Case StudyNew DataApplication of Novel Reactor Control Strategies for Upstream Bioprocess Development
In recent years, there has been a growing necessity to reduce the time, cost and risk associated to the development and scale-up of biopharmaceutical processes. The increasing pressures to reliably deliver critical quality attributes (CQAs) and process performance criteria (titre, cycle time, etc.) across manufacturing and supply scales compounds this challenge. As a result, process engineering strategies, to enable streamlined, reliable and robust scale-up, have become increasingly important. Within this presentation, novel process engineering strategies and technologies that facilitate the delivery of a robust process at scale will be discussed. This is achieved by identifying and implementing effective reactor control strategies. The application of novel scale down models, advanced process control and process modelling and simulation to upstream mammalian cell culture processes will be presented and illustrated through a number of case studies.
Jessica Whelan, Ph.D., Director, Tech Operations, Process Development, APC Ltd
Case StudyNew DataIdentification and Control of Novel Cell Growth Inhibitors in Fed Batch Cultures
Bhanu Chandra Mulukutla, Ph.D., Senior Scientist, Pfizer
Bioprocess "Problem-Solving" Discussion Topics and ModeratorsThese moderated discussions on a variety of bioprocess topics will allow you to share strategies and brainstorm solutions in an informal, small group setting.
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
Charles Sardonini, Ph.D., Director, Process Engineering/Development, Genzyme, a Sanofi company
High-Throughput Approaches to Process Development
Comparative Assessment of Bioanalyzer Technologies Through Analysis of Cell Culture Media Components
When optimizing cell culture media, accurately understanding culture conditions is critical for making parameter decisions to improve cell performance and protein quality. Having precise, real time data is essential for making feed and process decisions resulting in an optimally performing culture. A series of studies were conducted using the Roche Cedex Bio HT Analyzer and the NOVA BioProfile FLEX Analyzer to assess each instrument's accuracy and reproducibility. Ease of use and the overall instrument workflow were also evaluated to assess which instrument would better integrate into BD's media development and optimization processes. This evaluation was conducted over a four week period using four different analysts. Multiple metabolites were tested at various concentrations within each instrument's calibrated range to determine measurement accuracy. Spent and unspent media were also tested to determine measurement accuracy of each metabolite within the context of the complex media matrix. This study demonstrated the Bio HT Analyzer more precisely measured metabolites, especially when present at low concentrations. In summary, the combination of accurate data, improved workflow, and expanded application across our culture platform, the Bio HT enhances BD's media design capabilities.
Stacy Holdread, Staff Scientist, BD Biosciences, BD Advanced Bioprocessing
Case StudyNew DataMammalian Cell Culture Process Improvement Using Chemically Defined Media Via High Throughput Screening and Scale Up Production of a Monoclonal Antibody
Cell culture process development is challenge, because of long culture time and complicated media. In this study, high throughput screening with DOE design was effectively used to improve titer by 80% with chemically defined media to replace hydrolysate media in an old process. The new process was scaled up in 500-L bioreactors with similar drug substance quality attributes.
Jianlin (Jim) Xu, Ph.D., Senior Scientist II, Biologics Process Development, Bristol-Myers Squibb
New DataHigh Cell Density Fermentation of Micro Organisms for Production of Chemicals Using New Disposable High Throughput Ambr250™ Technology
The new system Ambr250™ technology is adapted for both microbial use, as well as, mammalian cell culture. The new single use 100-250 mL bioreactor vessels have been developed to avoid the need to clean reactors and sensors between fermentation runs. This enables all gas, liquid and sensor connections to be made, quickly and simply, for fast turnaround between experiments. Ingenza have been testing and comparing the new fermentation system to our standard 5 L fermentation system. The new system has enabled Ingenza to rapidly optimize our fermentation processes in a more efficient and economically competitive manner while still maintaining confidence that the resulting process is predictably scalable. During my talk I will detail our experience using this new system, comparing and contrasting result with those obtained from our standard fermentation process across a number of microbial production systems.
Alison Arnold, Ph.D., Head of Fermentation and Microbiology, Ingenza Ltd, United Kingdom
Ambr250™: An Advanced Tool for Optimisation and Process Development in Cell Culture Therapeutics
Nicolas Marceau, USP Laboratory Head, BST / BioRealization, Sanofi Aventis
Impact of Process Conditions on Product Quality
New DataImpact of Cell Culture Conditions and Cell Age on Sequence Variance
Karin Anderson, Ph.D., Associate Research Fellow, Pfizer
Case StudyPerfusion and XD Process Characterization, Building Robustness to Control Product Quality
The identification of critical process parameters can be understood through the execution of process characterization studies which can be guided by the assessment of parameter risk through failure mode effects analysis (FMEA). This case study represents the generation of process characterization data for a perfusion and XD process producing a complex recombinant biotherapeutic.
Shaun Eckerle, Senior Principal Scientist, Cell Culture Development, Patheon Biologics
Case StudyNovel Means to Reduce Acidic Species Varients on Recombinant Antibodies and Bispecifics
Patrick Hossler, Ph.D., Senior Scientist III, Process Sciences, AbbVie, Inc.
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
Pall Biopharmaceuticals' Leader Details Significant Technology Advances Enabling Integrated Continuous BioProcessing
There is a lot of talk about Continuous Bioprocessing, but how does the desire for a continuous bioprocess get turned into reality? Pall Life Sciences is committed to building a working GMP end-to-end continuous bioprocess. The building blocks are in place, now hear how they are to be assembled into an integrated process.
Note: The presentation will be followed by a curated tour of the technologies at the Pall booth
Michael Egholm, Ph.D., V.P. and General Manager, Pall Biopharmaceuticals, Pall Biopharmaceutucals Division, Pall Corporation
Networking Luncheon and Last Chance for Exposition Hall Viewing
Abel Hastings, Director of Process Sciences, Fujifilm Diosynth Biotechnologies
Process Characterization, QbD and Technology Transfers
New DataApplication of Equivalence Testing for Fed-Batch Production Cell Culture
Valerie A. Pferdeort, M.S., Engineer III, Cell Culture Development, Biogen, Inc.
Case StudyUse of Univariate and Multivariate Techniques for Targeted and Efficient Process Characterization: A Case Study
Dr. Graham McCreath, Ph.D., Head of Process Design, Fujifilm Diosynth Biotechnologies
Networking Refreshment Break
Process Characterization, QbD and Technology Transfers (continued)
New DataPerformance Consistency of Platform Fed-Batch Cultures across Multiple Systems Used in Industrial Process Development
The selection of a fed-batch cultivation system is often based on throughput and cost. However, the process knowledge derived from different systems and scales is not necessarily identical. Hence, a careful evaluation of systems which are already established or newly implemented is essential. Here, we describe the performance of 10 different recombinant CHO cell lines expressing the same antibody in fed-batch culture systems ranging from a few hundred microliters to lab scale. The 10 cell lines were selected based on distinct phenotypes covering a range which can be expected in typical industrial process development projects. The cell lines were cultivated using the same expansion and fed-batch protocol. The following cultivation systems were evaluated: shaking 96-deepwell plates, 50 mL vented shake tubes, micro- and lab-scale bioreactors. The results of this study show both the limitations and the potential of each cultivation system and their suitability for process development, process characterization and scale-up.
Matthieu Stettler, Ph.D., Manager, Biotech Process Sciences, Merck Serono SA
Application of Quality by Design (QbD) Principles to the Development, Characterization and Scale-up of a Late Stage Perfusion Cell Culture Process
This case study describes our systematic QbD approach to upstream development. Our approach involved manufacturability gap analysis, process parameter risk assessment, and design of experiment studies. In parallel, computation fluid dynamics and mathematical modeling were employed to support process scale-up. Through our systematic approach, we successfully developed, characterized, scaled-up and transferred a Phase III upstream process to a CMO GMP manufacturing facility.
Tom Hayes, Process Engineer III, Late Stage Process Development, Genzyme, A Sanofi Company
Case StudyNew DataAccelerated Late Stage Cell Culture Process Development to FacilitateTech Transfer and Ensure Success at Scale with Accelerated Timelines
This work describes rapid development of a monoclonal antibody production process to address manufacturing facility-fit concerns and improve production yield by 50% within 3 months. Process robustness studies were conducted to ensure the final successful large-scale GMP run. The improved process was then transferred to a manufacturing organization, with yield improvements and comparable product quality being further confirmed.
Yunling Bai, Ph.D., Senior Research Scientist, Upstream Process Development, Gilead Sciences, Inc.
Close of Conference