Early to Late Stage Bioprocess Development Summit
Event Information
Document Title
Agenda
| Pre-Conference Workshop Monday, October 20, 2008 | DAY ONE | DAY TWO | DAY THREE | | ||||
| Comparability Strategies for CMC Development | ||||
| In research for this conference, bioprocess development scientists expressed that the planning for the succession of comparability studies required in preclinical and clinical development continues to be a challenge. In addition to identifying the most accurate assays, there are a wide range of approaches to questions of working in-house versus outsourcing, timing, assay selection and integration with regulatory filings. The workshop offers case examples of how companies have approached these critical steps and provides an interactive forum for asking questions specific to different organizations and programs. | ||||
| 7:30 | Registration and Networking Coffee | |||
| 8:20 | Chairperson's Opening Remarks Kenneth G. Payie, Ph.D., Senior Research Scientist, Eli Lilly and Company | |||
| 8:30 | Long Range Planning of Characterization Studies There are various goals for characterization studies of biological drugs and these goals differ, if not in intent but in emphasis, during the drug life cycle. Goals change from forging the link between product quality and clinical performance to helping ensure that the licensed and marketed drug remains comparable to drug that was studied during clinical trials, during which safety and efficacy were established. Stability studies are an important aspect of characterization. Product characterization studies, with an emphasis on the lifecycle, will be discussed in this talk. William M. Egan, Ph.D., Vice President, PharmaNet Consulting | |||
| 9:00 | Regulatory Strategies for Comparability Studies Demonstrating comparability is an ongoing activity throughout the full lifecycle of product development from Phase I to post-approval. Understanding intrinsic structural characteristics of the drug candidate and developing a suitable analytical methods package for effective characterization early in development are integral parts of the comparability strategy. Regulatory considerations for assessing and demonstrating product comparability and how it can facilitate preclinical and clinical development are discussed. Joan M. Shankle, Managing Director, Aurum Group, LLC | |||
| 9:30 | An Early Phase Strategy for Chronic Tox Comparability Abstract to come. Kenneth G. Payie, Ph.D., Senior Research Scientist, Eli Lilly and Company | |||
| 10:00 | Networking Refreshment Break | |||
| 10:30 |
The presentation focuses on the use of LC/MS for advanced characterization of proteins. Intact mass analysis, mass information of peptides from protein digestion, and detailed characterization of modified proteins such as glyco proteins are illustrated. Examples include humanized monoclonal antibodies and recombinant proteins. John Gebler, Ph.D., Director, Biopharmaceutical Sciences, Waters Corporation | |||
| 11:00 | Comparison of Fc Glycosylation Profiles across Host Cells and Cell Lines for IgG Based Therapeutics using Mass Spectrometry Glycosylation heterogeneity at the Fc site is well known, but its variance across cell types and cell lines is not well documented. Methods for rapid characterization of glycoprofiles from several host cell types (HEK, CHO, NS0) and numerous cell lines, to assess variability at the conserved N-linked glycosylation site of multiple IgG-based therapeutics are presented. Steven C. Pomerantz, Ph.D., Senior Research Scientist, Centocor Research and Development | |||
| 11:30 | Panel Discussion with Workshop Speakers | |||
| 12:00 | Workshop Ends; Lunch on Your Own | |||
| Main Conference - Day One Monday, October 20, 2008 | PRE-CONFERENCE WORKSHOP | DAY TWO | DAY THREE | | ||||
| 1:00 | Registration | |||
| 1:50 | Chairperson's Opening Remarks T. Shantha Raju, Research Fellow, Centocor R&D, Inc. | |||
| Keynote Presentation | ||||
| 2:00 |
A process excellence initiative led to the establishment of the "Pharmaceutical Development Advisory Committee". This cross-functional team supports the selection of biologic candidates by understanding the impact of critical structural and biophysical properties on drug development. This presentation outlines the processes used to manage the interface between Discovery Research & Pharmaceutical Development and gives examples of case study successes. Mark Cunningham, Lead Development Coordinator, Discovery Research, Centocor, Inc. | |||
| Planning a Scientific Strategy for Early Development Molecules | ||||
| 2:45 |
Timelines for the development of biopharmaceutical processes are becoming increasingly aggressive. A well prepared analytical & formulation development strategy is required for the long-term success of a product throughout the clinical development lifecycle. Our strategy is also designed to support the transition from clinical to commercial manufacturing. Case studies are presented to highlight the analytical steps required for the rapid development of an antibody process and the formulation development of a complex recombinant protein. Prathima Acharya, Ph.D., Staff Scientist, Analytical and Formulation Development, Diosynth Biotechnology, a part of Schering-Plough Corporation | |||
| 3:15 |
CSL360 is a therapeutic antibody targeting leukemia stem cells, currently in Phase I trials for patients with acute myeloid leukemia. The development strategy paralleled rapid first in human studies with controlled process development to optimize the manufacturing process and prepare for scale up. Simultaneously, a strategic partnership was formed with a CMO to create a large scale manufacturing program suitable for Phase III trials and commercial supply. This approach has allowed CSL to effectively balance capital investment and risk. Anthony Stowers, Ph.D., Director, Bioprocess Development, CSL Ltd., Australia | |||
| 3:45 | Networking Refreshment Break; Opening of Poster and Exhibit Hall | |||
| 4:30 | How Physicochemical Studies can Support the Clone Selection Process During the development of therapeutic monoclonal antibodies, clone selection decisions are frequently made strictly on the basis of biological activity and do not take into account how sequence changes affect protein structure. To better inform the decision making process, we studied changes in physicochemical properties resulting from specific back mutations made after CDR grafting. A correlation was observed between favorable substitutions suggested by molecular modeling and measurable changes in pI, Tm, and fragment/aggregate levels. W. Blaine Stine, Ph.D., Associate Research Investigator, Protein Analytics, Abbott Bioresearch Center | |||
| Effective Outsourcing Strategies | ||||
| 5:00 | Early Stage mAb Outsourcing Strategy: Analytics to Support Rapid Process Optimization Abstract to come. Paul R. Mehelic, Group Leader and Principal Scientist, Analytical Research and Development, Pfizer Global Biologics | |||
| 5:30 | Efficient Project Management of Outsourced Biopharmaceutical Development and Manufacturing Programs Efficient and cost effective biopharmaceutical product development requires coordination of numerous activities, including cell line generation, upstream and downstream process development, preparation of reference standard, analytical method development and qualification, stability testing of process intermediates and final bulk product, and aseptic fill/finish activities. In this talk, the interplay and dependencies of different development tasks is reviewed and tools to manage these tasks is presented. Thomas C. Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc. | |||
| 6:00 | Close of Day One | |||
| Main Conference - Day Two Tuesday, October 21, 2008 | PRE-CONFERENCE WORKSHOP | DAY ONE | DAY THREE | | ||||
| 8:00 | Networking Coffee | |||
| 8:25 | Chairperson's Opening Remarks Noreen Troccoli, Ph.D., Senior Manager, Process Development, Genzyme Corporation | |||
| Keynote Presentation | ||||
| 8:30 | Product Quality Ownership throughout Clinical Product Development Abstract to come. Sharon Ma, Ph.D., Senior Scientist, Clinical Quality, Genentech, Inc. | |||
| Designing a Long-Term Analytical Development Program | ||||
| 9:15 | Surface Plasmon Resonance-based Binding Assay for Proteins - Development and Validation Considerations For use in a Quality Control environment, complex assays require thorough validation to assure ruggedness. The development, qualification and validation of a surface plasmon resonance (SPR)-based binding assay should reflect careful consideration of several factors including the nature of ligand-analyte interaction, purity of both ligand and analyte, the choice of immobilization chemistries and the mathematical model used to analyze the data. This presentation highlights the significance of several of these parameters for an SPR-based protein-binding assay. Vijay Dhawan, Ph.D., Staff Scientist, Bioanalytical Development, Genzyme Corporation | |||
| 9:45 | The Development of Downstream Scale-down Models and their Application and Limitations for Understanding the Manufacturing Design Space Scale-down models provide an understanding of process robustness, conduct viral clearance, column lifetime and cleaning studies, and support the scale-up and transfer of processes to new manufacturing sites. This talk presents a Genzyme approach to the development and qualification of scale-down models and discusses lessons learned from model application, including those in which the model was not representative of full scale. Examples of how scale-down models were used to troubleshoot full scale processes are also provided. Noreen Troccoli, Ph.D., Senior Manager, Process Development, Genzyme Corporation | |||
| 10:15 | Networking Break, Exhibit and Poster Viewing | |||
| 11:00 | Small Group Problem-Solving Discussions In this set of focused problem-solving discussions, audience members may select from a set of four themes, and then join a group of colleagues to discuss common issues that arise within that area and how those in the group approach solutions to these problems. Each discussion will have a moderator, and all members of the group are invited to participate in the conversation.
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| Technology Workshop | ||||
| 12:00 | Next Steps with Avecia’s pAVEway™ Avecia's pAVEway™ expression system has been successfully applied to antibody fragments of various types and has allowed titers of active products as high as 10g/L to be obtained in simple and rapid E.coli fermentations. Recent results from pAVEway™ together with further developments at Avecia will be described which simplify and standardize the purification of these molecules, allowing rapid process development and full exploitation of the high fermentation titers to reduce cost of goods.Andy Topping, Ph.D., Director, Early Phase Development, Avecia Biologics | |||
| 12:30 | Networking Luncheon, Exhibit and Poster Viewing | |||
| 1:55 | Session Chairperson's Opening Remarks Rajesh Krishnan, Ph.D., Senior Principal Scientist, Fermentation Development, Schering Plough | |||
| Planning and Execution of Process Development Strategies | ||||
| 2:00 |
Abstract to come. Victor A. Vinci, Ph.D., Head, Bioprocess Operations, Eli Lilly and Company | |||
| 2:30 |
Abstract to come. Rajesh Krishnan, Ph.D., Senior Principal Scientist, Fermentation Development, Schering Plough | |||
| 3:00 | Strategies for Lean but Not Mean Cell Line and Process Development To simultaneously bring multiple products through Phase III and beyond while working on other early stage projects, one not only needs to establish an efficient early-stage cell culture platform but also to perform lean but not mean optimization for late-stage process with scalability and productivity improvement, while conforming to product quality. This presentation shares such strategies and the results. Shue-Yuan Wang, Ph.D., Senior Director, Fermentation and Cell Culture Sciences, Human Genome Sciences, Inc. | |||
| 3:30 | Networking Break, Last Chance for Exhibit and Poster Viewing | |||
| 4:15 |
Chinese Hamster Ovary (CHO) cells are used extensively to produce recombinant proteins that require post-translation modification to express full biological function. A case study illustrates the strategic platform of SAFC Biosciences to efficiently develop optimized formulations for a humanized IgG-producing CHO clone. By collaborating with Xencor Inc. on downstream process optimization, monoclonal antibody production was significantly improved from 1 g/L to more than 3 g/L. In addition, an effective gene silencing strategy to enhance glycoprotein sialylation to improve protein quality will also be introduced. Min Zhang, Ph.D., Senior R&D Scientist, Cell Sciences & Development, SAFC Biosciences | |||
| 4:45 |
Statistical experimental design, or Design of Experiments (DOE), has been used for a number of years within the process industries. However, the application of this powerful technique has been somewhat limited within bioprocess development. This presentation describes how DOE can be applied to all stages of the product development cycle. Specific examples will be used to illustrate how DoE can be utilized to enable the rapid development of robust bioproduction processes. Jim Mills, Ph.D., Director of Operations, Xenova Biomanufacturing, United Kingdom | |||
| 5:15 | Close of Day Two | |||
| Main Conference - Day Three Wednesday, October 22, 2008 | PRE-CONFERENCE WORKSHOP | DAY ONE | DAY TWO | | ||||
| 7:45 | Networking Coffee | |||
| 8:10 | Chairperson's Opening Remarks Joseph Kutza, Ph.D., Associate Director, IMID CMC Regulatory Affairs, MedImmune, Inc | |||
| Bioprocess Quality Management Programs | ||||
| Keynote Presentations | ||||
| 8:15 | Quality by Design Initiative in the Biotechnology Industry In this presentation Quality by Design initiative and its implementation in biotechnology and biopharmaceutical industry will be addressed. Such elements of QbD as Design Space, Process Analytical Technology (PAT) and Critical Quality Attributes (CQA) will be considered. Designing experiments using multi-parameter limits will be discussed and the role of PAT in biopharmaceutical process development will be demonstrated. Applications of analytical technology and defining CQAs through comprehensive structure activity relationship (SAR) studies, characterization of structural and biological properties of a biomolecule variants, isoforms and product related impurities will be discussed. Yelena Lyubarskaya, Ph.D., Principal Scientist, Bioprocess Development, Biogen Idec | |||
| 9:00 | From Clone to Clinic - The Art and the Science of an Optimum Development Strategy Abstract to come. Nicholas W. Warne, Ph.D., Director, Formulations & DP Process Development, Wyeth BioPharma | |||
| 9:45 | Integration of Quality by Design into Biopharmaceutical Drug Product Development: Early and Late-Stage Approaches The presentation describes how QbD strategies were used during early and late-stage development of therapeutic antibody formulations. In early stage programs, formulation screening studies were performed using a matrix approach once key parameters and excipients were identified. QbD was also applied to a late-stage program to evaluate formulation robustness of the drug product both inside and outside of the specification design space. Tia Estey, Ph.D., Scientist II, Protein Pharmaceutical Development, Biogen Idec | |||
| 10:15 | Networking Break | |||
| Formulation Development | ||||
| 10:45 | Planning the Extent of Early Formulation Development Abstract to come. Min Huang, Ph.D., Senior Scientist, Pharmaceutical Research and Development, Pfizer Global Biologics | |||
| Regulatory Issues | ||||
| 11:15 | Regulatory Risk Management: Common CMC Hurdles and Approaches for Improving Application Quality Early to late stage development of biotechnology-derived protein therapeutics not only covers a wide range of product development and testing but a wide range of regulatory requirements as well. Keeping current with regulatory and scientific developments, maintaining a relationship with regulators and updating regulatory submissions with new information gathered during product development is critical to be able to meet clinical trial requirements and efficiently assemble a marketing application. CMC issues that commonly invite questions from regulators, or are sometimes forgotten by sponsors, will be discussed along with approaches that can improve submission quality and may reduce the number of comments and questions from regulators. Participants are encouraged to bring their own examples and ideas for discussion. Joseph Kutza, Ph.D., Associate Director, CMC Regulatory Affairs, MedImmune, Inc. | |||
| 11:45 |
The last stage in developing a successful commercial process is execution of process validation. Preparation of appropriate validation plans and selection of appropriate statistical analyses is a crucial yet sometimes overlooked element of process validation. This case study will demonstrate some approaches to process validation is selection of appropriate validation and sampling plans as well as statistical analyses that can facilitate regulatory review of process validation. Margaret Worden, Director of Manufacturing Sciences, Stryker Biotech | |||
| 12:15 | End of Conference | |||
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