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Biopharmaceutical Development & Production Week


Create Unique End-to-End Bioprocessing Solutions that Guarantee Reproducible Results and Manufacturing Success

March 30 - April 02, 2015 · Hyatt Regency Huntington Beach Resort & Spa · Huntington Beach, CA

Preliminary Agenda

Preliminary Agenda

Preliminary Agenda & Early Confirmed Speakers

Get out of the office and join a new how-to environment that lets you concentrate on development and production challenges in the most effective and efficient ways possible. No matter where you work in the development and production path, everyone in your organization can benefit by attending BDP Week 2015.

  Download the agenda-at-aglance

Process DevelopmentAnalyticalManufacturingQuality & Regulatory

9 Focused Tracks to Help Your Improve Speed, Quality, Efficiency and Compliance

Antibody Drug Conjugate Development & Production

  • Quality and Regulatory Considerations for ADCs
  • New Modalities and Next Generation ADCs - Challenges in Development and Production
  • Analytical Characterization for ADCs
  • Process Development Approaches
  • Scale Up, Facility Fit & Implementing Single-Use Systems for Manufacturing ADCs
  • Formulations and Fill/Finish for ADCs that are more potent and less stable

Downstream Processing

  • Advances at Harvest Step
  • Continuous Processing
  • Integrating Disposables (Clinical and Commercial) in Downstream Processing
  • Approaches to Improve Efficiencies and Reduce Timelines
  • Automated and High Throughput Process Development
  • Advances in Modeling, Characterization and Impurity Studies to Better Predict, Understand and Control Downstream Processes

Upstream Processing

  • Cell Line Development & Engineering
  • Improving and Controlling Process and Product Quality / Impact of Cell Culture on Critical Quality Attributes
  • Development of Biosimilars - Considerations during Cell Culture
  • Media Development Optimization
  • Single Use Applications in Upstream Processing
  • Approaches to improve Efficiencies and Reduce Timelines from Discovery to Clinic to Commercial
  • Novel Formats, Modalities & Non-Antibody-Based Products

Single-Use Applications for Biopharmaceutical Manufacturing

  • Ensuring Successful Single-Use Implementation and Integrity
  • Risk-Based Approaches for Effective
  • Single-Use Deployment
  • Town Hall: BPSA / Roundtable Discussions on Issues and Application of SU
  • Single-Use Considerations for Downstream Applications
  • Overcoming Challenges Associate with Particles and Extractables & Leachables
  • Single-Use Vs. Conventional

Manufacturing Efficiencies: Strategy & Technology

  • What is the Strategic Outlook for Manufacturing Capacity in This Industry?
  • Continuous Processing
  • Process Portability and Technology Transfer - Manufacturing for Global Markets
  • Biomanufacturing of the Future

Flexible Facilities

  • Non Classified and Close System Considerations
  • Process and Facility Design Strategies and Considerations
  • Multi-Product Facility Case Study and Considerations
  • Design-Build Considerations
  • Facility Case Studies
  • Biomanufacturing of the Future

Analytical Methods, Strategies and Technologies

  • Total HCP Control Strategies
  • High-Throughput Methods and Strategies
  • Aggregation and Subvisible Particle Characterization and Control
  • Aggregation / SUB particles 9:15:00 AM Glycan Analysis Considerations
  • Glycan Analysis Considerations
  • Analytical Strategies for Diverse Products

Bispecific Antibody & Production

  • Discovering, Designing and Developing Transformative
  • Bispecific Antibody Therapeutics
  • Approaches to Early and Late Stage Process Development
  • Overcoming Downstream Challenges and Developing
  • Purification Platforms
  • Innovative Solutions for the Production of Bispecifics

Quality and Control

  • Meet the New Challenges of Process Validation
  • Take the Next Steps in Process Validation Innovation
  • Take the Next Steps in Process Validation Innovation Validaton Program
  • Viral Safety
  • Best Practices to Detect and Thwart Adventitious Agents
  • Innovative Uses and Upcoming Challenges for Nanofiltration
  • Risk Assessments Via HTST Treatments
  • Contamination Control (Environmental and Microbial)
  • Managing Raw Materials Quality Control

Confirmed Speakers

  • Keynote Presentation: Samsung's Foray and Impact on the Global Biologics Industry
    Tae Han Kim, President and CEO, Samsung BioLogics
  • Keynote Presentation: Engineering Novel Proteins and Protein Assemblies As Innovative Therapeutics, Vaccines, and Drug Delivery Vehicles
    James Swartz, Ph.D., James H. Clark Professor, School of Engineering, and Professor of Chemical Engineering and of Bioengineering, Stanford University
  • Featured Presentation: Overcoming Analytical Challenges during Development and Production of ADCs
    Yan Chen, Ph.D., Technical Development Senior Scientist, Protein Analytical Chemistry, Genentech, Inc
  • Featured Presentation: What does the Industry Need to Change in Order to be Successful? What Is Required To Bring Industry to Next Level and Better Serve Patients Worldwide?
    Patricia Turney, Amgen
  • Regulatory Perspectives and Expectations for New Modalities, Linkers, Payloads and Platforms
    Karen Cha, Director, Regulatory Affairs, Agensys, Inc.
  • Development of a Platform Site-Specific Conjugation Process Applicable to Monoclonal and BiSpecific Antibodies
    Ellen O'connor, Ph.D., Senior Scientist, MedImmune
  • Probody Drug Conjugates (PDCs): A Path to Safer and More Effective ADCs
    Sridhar Viswanathan, Ph.D., Vice President, Process Sciences & Manufacturing, CytomX Therapeutics, Inc.
  • A versatile, modular approach to building customized, site-specifically conjugated ADCs using SMARTag™ technology
    Penelope M. Drake, Ph.D., Biology Group Leader, Catalent Biologics West - formerly Redwood Bioscience
  • Updates on Candidates in the Clinic
    Robert Lutz, Ph.D., Vice President, Translational Research & Development, ImmunoGen, Inc.
  • A Look Ahead - What's Coming from Research and Development?
    Peter D. Senter, Ph.D., Vice President, Chemistry and Distinguished Fellow, Seattle Genetics, Inc
  • Real-time Monitoring of ADC Conjugation Process
    Yan Chen, Ph.D., Technical Development Senior Scientist, Protein Analytical Chemistry, Genentech, Inc.
  • Analytical Development and Characterization Tools (3-D Structure of mAb/ADCs, Mass Spec)
    Oscar Salas-Solano, Ph.D., Senior Director of Analytical Sciences, Seattle Genetics, Inc.
  • Approaches to Development of Non-Toxic Surrogate Payloads to Perfect the Conjugation Chemistry
    Birte Nolting, Ph.D., Senior Principal Scientist, Pfizer
  • Raw Material Variability - Assessing Quality of Polysorbate in the Formulations of ADCs
    Sonia Taktak, Ph.D., Analytical Scientist III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.,
  • A Novel Antibody Drug Conjugation Method Using Ambrx's EuCode™ Technology and Its Application in Product Development - Case Studies of Conjugation Development and Scale-Up for Clinical Manufacturing
    Yun Bai, Ph.D., Associate Director, Process Development, Ambrx Inc.
  • Rapid Scale Up and Facility Fit for a Mammalian Cytokine Developed in E.coli that was Destined to be Part of a Bioconjugate
    Shuang Chen, Ph.D., Principal Scientist, Pfizer Inc.
  • Single-Use Applications for ADCs
    Mary Robinette, Process Lead, Engineering, Sigma Aldrich
  • Manufacturing ADCs Utilizing Full-Disposable System
    Presented by Lonza
  • Health and Safety Issues as ADCs get More Potent
    Farrah Chaudhary, Contract Manufacturing Project Manager, ImmunoGe
  • ADC Formulation Development
    Janet Wolfe, Ph.D., President, Wolfe Laboratories
  • Conjugation & Fill/Finish: A New Concept Applied to the Supply Chain of ADCs, "from Earlier Conjugation Development to GMP Commercial Manufacturing
    Maria Elena Guadagno, Ph.D., Business Director, BSP Pharmaceuticals, Italy
  • Ultra scale-down characterization of bioprocessing materials for the early prediction of the impacts of industrial scale continuous centrifugation on the recovery and purification of new therapeutic candidate
    Alex Chatel, Ph.D., Bioprocess Enterprise Fellow, Biochemical Engineering, University College London, United Kingdom
  • Overcoming Reduction of Antibodies in Harvest Step
    Michael Laird, Genentech
  • Upstream Disposable Technology Supports the Implementation of Continuous Processing
    Shaun P. Eckerle, Principal Scientist, Cell Culture Development, Patheon Biologics
  • Platform Downstream Processes in the Age of Continuous Chromatography: A Case Study
    Funn Hung, Merck & Co.
  • Integrated and Fully Continuous Processing of Recombinant Therapeutic Proteins - From Cell Culture Media to Purified Drug Substance
    Veena Warikoo, Genzyme
  • Exploring Options for Continuous Diafiltration -Evaluate challenges, benefits and drawbacks for a continuous diafiltration process as compared to fed-batch UFDF
    Alex Brinkmann, Engineer III, Biogen Idec, Benoit Mothes, Pharm D, Senior DSP Scientist, Sanofi, France
  • Implementing an Aggressive Disposables Strategy
    David Pollard, Merck
  • Disposable Membrane Chromatography Systems as a Platform for mAb Purification
    Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon
  • The Evaluation of Disposable Column Components and Disposable Columns in Place of Traditional Stainless Steel Chromatography Column Equipment Used in Large Scale Bio-Processing
    Shaun Grier, Process Development, Shire
  • Development of a Streamlined and Cost-effective Downstream Process for Broadly Neutralizing Monclonal Antibody for HIV - From Bench to Clinical Manufacturing
    Xun Liu, Director and Staff Scientist, Vaccine Production Program Laboratory, National Institutes of Health
  • Practical Application in Modeling(Approaches and Tools) for Debottlenecking and Improving Process Efficiencies and Understanding
    Presented by: Genentech
  • Time to Clinic
    Edward Koepf, Biogen Idec
  • Robo-Characterization: Can HTS Miniature Columns Predict a Manufacturing Future?
    Jennifer Pollard, M.S., Principal Scientist, Merck & Co,
  • High Throughput Process Development: QbD Studies Across Multiple Formats
    Alex Berrill, Eng.D., Principal Scientist, Purification, Pfizer
  • Computational Modeling: Insights into Molecular Biophysics to Advance and Improve Biologics Purification
    David Roush, Merck,
  • Challenges and Solutions for Process Characterization of a Recently Approved Product (Cyramza)
    Richard Chin, Imclone
  • Novel Impurity Challenge Study in mAb Downstream Process
    Bo Qi, Eli Lilly
  • An Integrated Cell Line Development Platform for Generation of High Yielding CHO and 293 Stable Cell Lines Expressing Monoclonal Antibodies and Recombinant Viral Glycoproteins
    Althaf Hussain, Ph.D., Director, Cell Line and Pre-clinical Development, Vaccine Production Program lab, Vaccine Research Center, NIH,
  • Platform High-throughput Clone and Cell-line Selection Process for a Protein Therapeutic
    Bruce Tangarone, Associate Director, Analytical Development, Shire HGT
  • Approaches to Process Validation and Continuous Verification
    Steve Meier, Ph.D., Genentech,
  • A Roadmap for Improvement in Control Strategy using "Retrospective" Quality by Design (QbD) Principles for a Commercial Molecule
    Anup Agarwal, Ph.D., Senior Development Engineer I, Commercial MS&T, Shire HGT,
  • The Production of Antibodies as Single Glycoforms or with a Restricted Glycosylation Profil
    Michael Butler, Ph.D., Professor of Microbiology, University of Manitoba, Canada
  • Challenges in Comparability Studies of Carbohydrate Containing Biosimilars
    Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia
  • Evaluation of Alternatives to Animal Derived Reagents Used for Productivity Enrichment During Cell Line Development
    Christina Alves, Ph.D., Scientist II, Biogen Idec
  • Impact of Extractables and Leachables on Cell Culture
    Sally Kline, Ph.D., Scientific Director, Materials Science, Amgen
  • Scale up and tech transfer of a high cell density perfusion cell culture process utilizing a CHO cell line
    Rahul Chelikani, Ph.D, Senior Bioengineer, Shire HGT
  • Challenges of Cell Culture and Harvest for a High Cell Density Process in Disposables Platform
    Sigma S. Mostafa, Ph.D., Director, Process Development, KBI Biopharma
  • Streamlining Workflow from Discovery Through Clinic
    Daryl Powers, Ph.D., Staff Scientist, Early Cell Culture Process Development, Genzyme
  • Development of Complex Antibody-Cytokine Fusion Proteins at High Quality by an Integrative Early Development Approach
    Markus Neubauer, Ph.D., Principal Scientist, Cell Culture Research, Large Molecule Research, Roche Innovation Center, Pharma Research and Early Development (pRED), German
  • Finding Manufacturing Space for Early Manufacturing - Impact of Tighter Capacity on Industry
    Thomas C. Ransohoff, Vice President & Principal Consultant, BioProcess Technology Consultants, Inc.
  • 20 Years of Successful Transfers into Lonza Portsmouth: Early Adoption of Best Practices leads to Long Term Success
    Presented by: Lonza
  • Experiences from CMC Due Diligences of Early to Mid-Phase Antibody Projects
    Christain Cimander, Ph.D., Director, CMC Operations, Genmab AS
  • Development, Scale-Up and Process Validation of Anthim®: A Case Study in Effective CMO Management & Collaboration
    Pamela Wright, Ph.D., Senior Director of Manufacturing, Development & Manufacturing, Elusys Therapeutics, Inc.
  • BARDA Core Services enhancing Vaccine Development and Manufacturing
    Arlene Joyner, MS PMP, Project Officer, Manufacturing Facilities and Engineering Division, Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS)
  • Nothing to be Scared of, a lot to be Gained
    Sadettin S. Ozturk, Ph.D., Assoc. Deputy Director, Process and Analytical Development, MassBiologics of the University of Massachusetts Medical School
  • Approach to Rapid Global Deployment with Modular Facilities for Filling and Bulk Biologics
    Marc Devlaminck, Associate Director Engineering, Architect, Merck
  • Utilization of Facilities
    Phil McDuff, Sr. Director, Engineering, Biogen Idec
  • Defining Flexible and Multiuse Facilities
    Alain Pralong, Vice President New Production Introduction & Life Cycle, GSK Biologicals
  • Pushing the Controlled Non-Classified (CNC) envelope with the application of single use systems for bioprocessing
    Kenneth D. Green, Ph.D., Director, Continuous Improvement, Global Technical Services, Pfizer, Inc.
  • Processes of the Future : Single Use, Closed and Continuous for Faster, Cheaper and Safer manufacturing
    Sébastien Ribault, Ph.D., Director Biotechnology/Life Science, Head of BioDevelopment Center, Merck Millipore
  • Flexible modular facilities for contract manufacturing and training - The National Center for Therapeutics Manufacturing
    Michael Pishko, Ph.D., Associate Principal Investigator, Texas A&M Center for Innovation in Advanced Development and Manufacturing
  • Implementation strategies and challenges for single use in a large company setting
    Adam Goldstein, Genentech
  • Strategies for implementing single-use technologies in biopharmaceutical manufacturing
    Ying Gao, Ph.D., Process Analytical & Development Group, Development &Production, Public Health England
  • Implementation of Single-Use Technology for Production of the UK Anthrax Vaccine
    Kelly Thomas, Senior Project Team Leader, Vaccine Research Group, Public Health England
  • "Flexible & Multiproduct Facility: Disposables & Biocontainment Strategy
    Tammy Conrad, Sanofi Pasteur
  • Case Study of 12 Flexible Facility Biopharm Projects: Emerging trends in Flexibility for Strategic Advantage
    Niels Guldager, Senior Technology Partner, Senior Technology Partners, NNE Pharmaplan
  • Antigen Excess and Avoiding HCP Quantitation Errors
    Sara Parker, Ph.D. Senior Manager Analytical Operations, Genentech, Inc.
  • Analytical challenges and solutions for in-house HCPs assay development, case studies from HCPs antigen selection to anti-HCPs reagents qualification
    Fengqiang Wang, Ph.D., Principal Scientist, Sterile Product and Analytical Development, Merck
  • Multidimensional Analysis of mAb Formulations by High Throughput Methods
    Vladamir Razinkov, Principle Scientist, Process & Product Development, Amgen, Inc.
  • High Throughput Determination of IgG Titer in Cell Culture via Affinity Chromatograph
    Kevin Lin, Research Associate, Genentech
  • Assays of Higher Throughput for Efficient Measurement of Drug Potency and Impurity
    Wei Zhang, Ph.D., Principal Scientist, Analytical Development, Biogen Idec
  • Probing Structurally-Altered and Aggregated States of Therapeutically Relevant Proteins Using GroEL Coupled to Bio-Layer Interferometry
    Mark Fisher Ph.D., Professor, Department of Biochemistry and Molecular Biology, Robert E. Hemenway Life Sciences Innovation Center, University of Kansas Medical Center
  • Monitoring and Control of Particulates in Protein Therapeutics
    Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems, a wholly owned subsidiary of Eli Lilly &Co
  • New Steps to Ensure Successful Product Package Integrity Evaluations
    Donald Singer, Global Lead Quality Manager, Microbiology, R&D, GlaxoSmithKline
  • Comparison of Glycoproteins by Hydrogen-Deuterium Exchange-Electron Transfer Dissociation-Mass Spectrometry
    Jeffrey W. Hudgens, Ph.D., Research Chemist, Institute for Bioscience and Biotechnology Research (CARB II/2204B), BioProcess Measurements Group (Div. 645.07), Biomolecular Measurement Division, National Institute of Standards and Technology (NIST)
  • Orthogonal Analytical Characterization in Supporting Process Development
    Qin Zou, Ph.D, Senior Principal Scientist , Pfizer, Inc.
  • Comprehensive N-glycosylation characterization of Biopharmaceuticals
    Andras Guttman, Ph.D., Professor, Horvath Laboratory of Bioseparation Sciences, University of Debrecen, MMKK
  • Glycan Analysis: An Updated Method for Existing Products
    Deanna Hurum, Ph.D., QC Scientist, Global Method Management and Technology, Genentech, a Member of the Roche Group
  • Don't Go Into the Light! Analytical Characterization of a Photosensitive Therapeutic IgG1 Antibody After Exposure to Light
    Galahad Deperalta, Scientist, Protein Analytical Chemistry, Genentech, a member of the Roche Group
  • Overcoming Regulatory Challenges with Endotoxin Recovery Studies During Process Validation
    Donald Singer, Global Lead Quality Manager, Microbiology, R&D, GlaxoSmithKline
  • How Bristol-Myers Squibb Uses the FDA's Breakthrough Therapy Designation
    Kristen Manchester, Scientist, Manufacturing Sciences and Technology, Bristol-Myers Squibb
  • How to Protect GMP Facilities from Viral Contamination
    Paul W. Barone, Ph.D., Associate Director, BioMANufacturing Program, Center for Biomedical Innovation, Massachusetts Institute of Technology
  • State-of-the-Art Approaches to Robust and Effective Nanofiltration
    Nathan Roth, Ph.D., Director, Pathogen Safety, Global R&D, CSL Behring
  • Case Study: How to Design and Operate an HTST Skid
    Bill Ogden, Associate Director, Engineering Services, MedImmun
  • IIntegrity Testing of Single-Use Assemblies
    Weibing Ding, Ph.D., Principal Scientist, Materials Science, Amgen Inc
  • Genentech's approach to the regulatory environment surrounding disposables
    Kellen Mazzarella, Associate Regulatory Program Director, Genentech, a member of the Roche Group
  • Ensuring Single-Use System Reliability
    Mark A. Petrich, Ph.D., Associate Director, Component Engineering, Merck & Co.
  • Single-Use System: Obstacles to Implementations
    Christopher J. Smalley, Ph.D., Director of Validation Compliance, Merck & Co.
  • Particulate control recommendations for single-use
    James Dean Vogel, P.E., The BioProcess Institute
  • Integrated a fully disposable centrifuge into my completely disposable facility (200L scale)
    Brad Ebel, Manager, LSDL, Shire
  • Case Study for Rapid Development and Scale-Up of a High Productivity CHO Process for a Novel Anti-HIV mAb
    Bhargavi Kondragunta, Ph.D., Vaccine Production Program, Vaccine Research Center, NIAID, NIH
  • Downstream Application for Fill Finish
    Vivan Tsai, Senior Engineer, Amgen
  • Case study on single-use vs. reusable probes
    Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech
BPI 2015

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