Biotech China 2014

Schedule of Presentations:

Sunday, September 30, 2007
13:00:00 Pre-Conference Workshop B: Chairperson's Opening Remarks Yves Durocher
13:00:00 Pre-Conference Workshop B (13:00 - 17:00) Henry Chiou, Alison J. Mastrangelo, Gerald F. Casperson, Yves Durocher, Lekan Daramola
13:10:00 Pre-Conference Workshop B: Introduction to Transient Expression Systems Yves Durocher
13:30:00 Pre-Conference Workshops A & B (13:30 - 17:00) Henry Chiou, Nadine M. Ritter, Lekan Daramola, Gerald F. Casperson, Richard Francis, Alison J. Mastrangelo, Yves Durocher, Keith H Wells, Hersh Mehta
13:30:00 Pre-Conference Workshop A (13:30 - 17:00) Nadine M. Ritter, Hersh Mehta, Keith H Wells, Richard Francis
13:30:00 Pre-Conference Workshop A: Co-Chairperson's Opening Remarks Nadine M. Ritter, Keith H Wells
13:40:00 Pre-Conference Workshop A: Analytical Methods for Biotechnology Products: Heroic or Horrific? Nadine M. Ritter
13:50:00 Pre-Conference Workshop B: Development Towards High Yield in Large Scale Transient Protein Production in CHO Henry Chiou
14:10:00 Pre-Conference Workshop A: Regulatory Overview of Process Development Keith H Wells
14:30:00 Pre-Conference Workshop B: Protein Production Via Large Scale Transient Transfection of Mammalian Cells Gerald F. Casperson
14:40:00 Pre-Conference Workshop A: Networking Refreshment Break
15:00:00 Pre-Conference Workshop A: Voraxaze: Meeting the Regulatory Challenge Richard Francis
15:10:00 Pre-Conference Workshop B: Networking Refreshment Break
15:30:00 Pre-Conference Workshop A: Vaccine for CDAD - Challenges in Analytical Method Development for Process, Formulation, and Product Hersh Mehta
15:40:00 Pre-Conference Workshop B: Addressing IgG Expression Issues and Improving Productivity during Transient Expression Lekan Daramola
16:00:00 Pre-Conference Workshop A: Audience Interactive Panel Discussion with all Speakers
16:20:00 Pre-Conference Workshop B: Novel Approaches for the Improvement of Transient Expression using CHO Cells Alison J. Mastrangelo
17:00:00 Pre-Conference Workshop B: End of Workshop
17:00:00 Pre-Conference Workshop A: End of Workshop
Monday, October 1, 2007
07:00:00 Scaling Up from Bench through Commercialization , Best Practices for Strategic Scale Up Decisions : Registration and Coffee
07:00:00 Production & Economics of Biopharmaceuticals, Strategies for Flexible Facility Design and Capacity Optimization (07:00 - 11:30) Kristi M. Huntington, Michael A. Tyo, John Ward, Kevin Hanley, James Bouressa,, Andrew R. Ramelmeier, Abhinav Shukla
07:00:00 Production & Economics of Biopharmaceuticals: Registration and Coffee
07:00:00 Scaling Up from Bench through Commercialization , Best Practices for Strategic Scale Up Decisions (07:00 - 12:15) George Koch, Nicolas Voute, Ellen L. McCormick, Jose M. Hanquier, Robert J. Todd, Tom Ransohoff, Thomas J. Murphy, Robert S. Gronke, David H. Reifsnyder
08:00:00 Strategies for Flexible Facility Design and Capacity Optimization: Chairperson's Remarks Abhinav Shukla
08:00:00 Best Practices for Strategic Scale Up Decisions: Chairperson's Remarks and Update on the Antibody and Non-Antibody Pipelines Tom Ransohoff
08:15:00 Strategies for Flexible Facility Design and Capacity Optimization : Critical Considerations for Biologics Facility Planning, a Global Perspective John Ward
08:15:00 Best Practices for Strategic Scale Up Decisions: Connecting the Dots between Process Platforms and Facility Design Robert J. Todd
08:45:00 Strategies for Flexible Facility Design and Capacity Optimization : Adding Product #2 to an Existing Plant: Strategies and Challenges for Growth Andrew R. Ramelmeier
08:45:00 Best Practices for Strategic Scale Up Decisions: Evolution of a Process Development Strategy David H. Reifsnyder
09:15:00 Best Practices for Strategic Scale Up Decisions: Design Space for Late Stage Process Optimization: Application to Process Robustness at Commercial Scale Case Study Jose M. Hanquier
09:15:00 Strategies for Flexible Facility Design and Capacity Optimization : Capacity Planning for Late Stage Development and Commercial Launch Michael A. Tyo
09:45:00 Best Practices for Strategic Scale Up Decisions: Networking Refreshment Break
09:45:00 Strategies for Flexible Facility Design and Capacity Optimization : Networking Refreshment Break
10:15:00 Strategies for Flexible Facility Design and Capacity Optimization : Optimizing the Use of a Multi-Product Biologics Clinical Manufacturing Facility Case Study James Bouressa,
10:15:00 Best Practices for Strategic Scale Up Decisions: Challenges of Developing a Process for a PEGylated Protein Case Study Robert S. Gronke
10:45:00 Best Practices for Strategic Scale Up Decisions: CP-675,206: Manufacturing Strategy toward BLA/MAA Case Study Ellen L. McCormick
10:45:00 Strategies for Flexible Facility Design and Capacity Optimization : Technology Transfer: A Streamlined Business Approach to Lessen the Burden on a Multi-Project Facility Kristi M. Huntington
11:15:00 Strategies for Flexible Facility Design and Capacity Optimization : Retrospective Performance Review of a Flexible Facility Design Kevin Hanley
11:15:00 Best Practices for Strategic Scale Up Decisions: Audience Interactive Panel Discussion The Impact of Regulatory and Industry Trends on Process Development and Manufacturing Strategies Tom Ransohoff
11:45:00 Best Practices for Strategic Scale Up Decisions: Concurrent Technology Workshops ; Celsius: 1L and 2L Single-Use Containers for Freezing Application Nicolas Voute
11:55:00 Best Practices for Strategic Scale Up Decisions: Concurrent Technology Workshops; Validation of Single-Use Bioprocess Containers: Film Structure and Impact on Leachables and Extractables Thomas J. Murphy
12:05:00 Best Practices for Strategic Scale Up Decisions: Concurrent Technology Workshops; Reducing Cost-of-Goods for Commercial Products by Design Space Analysis George Koch
12:15:00 Best Practices for Strategic Scale Up Decisions: Lunch on your own
13:45:00 Scaling Up from Bench through Commercialization ; Regulatory and Quality Considerations (13:45 - 17:45) Thomas P. Garcia, Mary B. Sliwkowski, Markus Gemuend, Jeffrey C. Baker, Christina Graffner, Michael E. Kamarck
13:45:00 Production & Economics of Biopharmaceuticals : Enhancing Operational Excellence and Process Efficiencies (13:45 - 15:30) Mark Skoog, Dominique Sexton, Lisa Cozza, Duncan Low
13:45:00 Enhancing Operational Excellence and Process Efficiencies : Chairperson's Remarks Duncan Low
13:45:00 Regulatory and Quality Considerations : Chairperson's Remarks Jeffrey C. Baker
14:00:00 Regulatory and Quality Considerations : Update on Experience with FDA Pilot Program Thomas P. Garcia
14:00:00 Enhancing Operational Excellence and Process Efficiencies : Developing Clinical Manufacturing Business Strategies to Enable a High-Throughput Project Portfolio Dominique Sexton
14:30:00 Regulatory and Quality Considerations : Pharmaceutical Development Documentation within the EU Regulatory System Christina Graffner
14:30:00 Enhancing Operational Excellence and Process Efficiencies : The Path to Operational Excellence at HGS Lisa Cozza
15:00:00 Regulatory and Quality Considerations : A Biopharmaceutical Industry Perspective on Quality By Design Mary B. Sliwkowski
15:00:00 Enhancing Operational Excellence and Process Efficiencies : Fermentation Operational Excellence Case Study Mark Skoog
15:30:00 Regulatory and Quality Considerations : Networking Refreshment Break
15:30:00 Enhancing Operational Excellence and Process Efficiencies : Networking Refreshment Break
16:00:00 Regulatory and Quality Considerations : KEYNOTE PRESENTATION; Biomanufacturing Capacity - Chapter and Verse Michael E. Kamarck
16:45:00 Regulatory and Quality Considerations : KEYNOTE PRESENTATION; Genentech's Manufacturing Strategy and Vision of Future Needs Markus Gemuend
17:30:00 Regulatory and Quality Considerations : Exhibit Hall Opens with Cocktail Reception
Tuesday, October 2, 2007
07:00:00 Technology Workshop: Registration and Coffee
07:15:00 Technology Workshop: Reaching Extremely High Protein & Antibody Expression 30-80pg/Cell/Day in Three Weeks in Fast-Growing Cho Cells Matthew Hui
07:30:00 Scaling Up from Bench through Commercialization : Coffee
07:30:00 Production & Economics of Biopharmaceuticals ; Scaling Up from Bench through Commercialization (07:30 - 12:00) Ed Goudreau, Alex Fotopoulos, Kevin Hanley, Eric C. Jensen, Bob Steininger, Tom Ransohoff, Jeffrey C. Baker, John Finkbohner, Gunter Jagschies
07:30:00 Cell Culture & Upstream Processing: Coffee
07:30:00 Recovery & Purification : Coffee
07:30:00 Recovery & Purification (07:30 - 08:45) John Curling, Edward Cole
07:30:00 Cell Culture & Upstream Processing (07:30 - 08:15) Dennis M. Kraichely, Kathie Fritchman
08:00:00 Scaling Up from Bench through Commercialization : Co-Moderator's Opening Remarks and Panel Introductions
08:00:00 Production & Economics of Biopharmaceuticals ; Market Forces and Technology Developments Affecting Economics of Biopharmaceuticals (08:00 - 11:30) Dianne Jackson Matthews, Craig E. Sandstrom, Abhinav Shukla, Inger Mollerup, Joseph K. McLaughlin, Alex Fotopoulos, Gunter Jagschies
08:00:00 Scaling Up from Bench through Commercialization ; Scale Down Models, Process Characterization and Validation (08:00 - 12:00) Roger A. Hart, Reuben Cohen, Steven K. Rausch, Michael Gramer, Srikanth R. Chary, Richard Francis, Jonathan Romero
08:00:00 Scale Down Models, Process Characterization and Validation : Chairperson's Remarks Roger A. Hart
08:00:00 Market Forces and Technology Developments Affecting Economics of Biopharmaceuticals : Chairperson's Remarks Alex Fotopoulos
08:00:00 Recovery & Purification : Chairperson's Opening Remarks Edward Cole
08:05:00 Cell Culture & Upstream Processing: Chairperson's Opening Remarks Dennis M. Kraichely
08:15:00 Scaling Up from Bench through Commercialization : Discussion Begins
08:15:00 Scale Down Models, Process Characterization and Validation : Predictive Scale-Down Models for Cell Culture: Avoiding Pitfalls and Establishing Model Comparability Srikanth R. Chary
08:15:00 Recovery & Purification : Featured Presentation ; Lessons Learned and Not - Future Directions in Chromatography John Curling
08:15:00 Discussion Session 1: Strategies for Small Companies Managing Late Stage Development Tom Ransohoff, Bob Steininger
08:15:00 Early Stage Process Development - Getting to Clinic Faster (8:15 - 11:30) Alison Porter, Amy Shen, Florence Wu, Torsten W. Schulz, Jianguo Yang, Sunil Mehta
08:15:00 Market Forces and Technology Developments Affecting Economics of Biopharmaceuticals : Leveraging Contract Manufacturing as a Market Entry Strategy for Biologics Case Study Abhinav Shukla
08:15:00 Early Stage Process Development - Getting to Clinic Faster : CHO BI-HEX™ - A Unique Improvement Platform that Secures Fast Time to Clinic Torsten W. Schulz
08:45:00 Next Generation / Disruptive Purification Technologies (08:45 - 13:00) Jie Chen, Mark R. Etzel, Genova A. Richardson, Ping Y. Huang, John Liddell, Christine Gebski, Stephen K. Tingley, David Wood
08:45:00 Next Generation / Disruptive Purification Technologies : Self-Cleaving Inteins and Affinity Resin Substitutes for Non-Chromatographic Protein Purification David Wood
08:45:00 Market Forces and Technology Developments Affecting Economics of Biopharmaceuticals : Using Process Simulation to Prioritize Development Activities Case Study Joseph K. McLaughlin
08:45:00 Early Stage Process Development - Getting to Clinic Faster : Behavior of GS-CHO Cell Lines in a Selection Strategy Alison Porter
08:45:00 Scale Down Models, Process Characterization and Validation : Scaling up T cell Processing from a Phase I Clinical Trial to a Phase II Clinical Trial Case Study Reuben Cohen
09:15:00 Market Forces and Technology Developments Affecting Economics of Biopharmaceuticals : mAb Processes: Production Scenarios from 100 to 10,000 kgs per Year Gunter Jagschies
09:15:00 Scale Down Models, Process Characterization and Validation : Case Studies into Small Scale Process Models and Lessons Learnt Case Study Richard Francis
09:15:00 Next Generation / Disruptive Purification Technologies : Design Optimal Process Flow Platforms for Monoclonal Antibody Downstream Purification Manufacture Jie Chen
09:15:00 Early Stage Process Development - Getting to Clinic Faster : A Platform Strategy for Fast Development of High-Producing NS/0 Production Cell Lines in Animal Protein Free Medium Jianguo Yang
09:15:00 Discussion Session 2A: Modeling Up and Scaling Down: Use of Model Systems in Validation Assurance Jeffrey C. Baker, John Finkbohner
09:45:00 Scale Down Models, Process Characterization and Validation : Networking Refreshment Break in Exhibit and Poster Hall
09:45:00 Market Forces and Technology Developments Affecting Economics of Biopharmaceuticals : Networking Refreshment Break in Exhibit and Poster Hall
09:45:00 Next Generation / Disruptive Purification Technologies : Networking Refreshment Break in Exhibit and Poster Hall
09:45:00 Scaling Up from Bench through Commercialization : Networking Refreshment Break in Exhibit and Poster Hall
09:45:00 Early Stage Process Development - Getting to Clinic Faster : Networking Refreshment Break in Exhibit and Poster Hall
10:30:00 Next Generation / Disruptive Purification Technologies : Development of a Low pH Cell Removal and its Scale up to 10KL Scale for Large-Scale Antibody Manufacturing Ping Y. Huang
10:30:00 Discussion Session 2B: Quality by Design: Aspiration and Application Jeffrey C. Baker, Eric C. Jensen
10:30:00 Early Stage Process Development - Getting to Clinic Faster : Therapeutic Antibody Production Cell Line Development with an Improved Selection Process and Accelerated Timeline Amy Shen
10:30:00 Scaling Up from Bench through Commercialization : Discussion Resumes
10:30:00 Market Forces and Technology Developments Affecting Economics of Biopharmaceuticals : Single Use / Disposable Technology Case Studies for Biopharmaceutical Manufacturing Case Study Craig E. Sandstrom
10:30:00 Scale Down Models, Process Characterization and Validation : A Novel Statistical Approach to Setting Process Validation Acceptance Criteria Steven K. Rausch
11:00:00 Scale Down Models, Process Characterization and Validation : Disc Stack Centrifugation 2L to 20,000L Scale-up Evaluation for Mammalian Cell Clarification: Optimization of Bioreactor Harvest Conditions for Combined Cell Removal and mAb Purification Capabilities Case Study
11:00:00 Market Forces and Technology Developments Affecting Economics of Biopharmaceuticals : Biosimilars/Follow-on Biologics: Overview of Scientific/Regulatory Guidelines and Experience Inger Mollerup
11:00:00 Early Stage Process Development - Getting to Clinic Faster : Fluorescent Protein A/G Based Antibody Secretion Detection Assay Sunil Mehta
11:00:00 Next Generation / Disruptive Purification Technologies : Charged Membranes and Monoliths in Chromatography Mark R. Etzel
11:00:00 Discussion Session 3: The Impact of Evolving Process Capabilities and Adaptations on Facilities Kevin Hanley, Ed Goudreau, Alex Fotopoulos, Gunter Jagschies
11:30:00 Next Generation / Disruptive Purification Technologies : New Stationary Phases in Chromatography John Liddell
11:30:00 Scale Down Models, Process Characterization and Validation : Use of a Scale-Down Cell Culture Model to Support the Successful Start-Up of a New 10kL Manufacturing Facility Michael Gramer
11:30:00 Early Stage Process Development - Getting to Clinic Faster : Suspension of DNA Mismatch Repair Allows for the Isolation of CHO Cells Resistant to High Osmolarity Florence Wu
11:30:00 Market Forces and Technology Developments Affecting Economics of Biopharmaceuticals : The Challenges of Comparability for Biosimilar Medicines Dianne Jackson Matthews
12:00:00 Concurrent Technology Workshops : Disposable Biopharmaceutical Processes - Advances and Benefits Maik W. Jornitz
12:00:00 Concurrent Technology Workshops : A Rational Approach to Culture Media Design and Basic Process Integration Scott D. Storms
12:00:00 Concurrent Technology Workshops (12:00- 12:30) Maik W. Jornitz, Scott D. Storms, Peggy Lio, Henrik Ihre
12:00:00 Concurrent Technology Workshops : Cell Xpress™ Technology Facilitates High-Producing Chinese Hamster Ovary Cell Line Generation Using Glutamine Synthetase Gene Expression System Genova A. Richardson
12:00:00 Concurrent Technology Workshops (12:00 - 13:00) Christine Gebski, Genova A. Richardson, Stephen K. Tingley
12:00:00 Scaling Up from Bench through Commercialization : Discussion Ends
12:00:00 Concurrent Technology Workshops : POROS® Chromatography Media: The Fix for Your Downstream Process Bottleneck Christine Gebski
12:00:00 Concurrent Technology Workshops : Sequential Multi-Column Chromatography - Enabling Continuous Downstream Processing Stephen K. Tingley
12:00:00 Cell Culture & Upstream Processing:Session Sponsor's Introduction Kathie Fritchman
12:00:00 Cell Culture & Upstream Processing : Chairperson's Remarks Kevin J. Kayser
12:00:00 Concurrent Technology Workshops : Advances in Clone Selection: Cloning Media and Selection Criteria are Critical Peggy Lio
12:00:00 Concurrent Technology Workshops : Multimodal Chromatography - For New and Old Separation Challenges Henrik Ihre
12:30:00 Concurrent Technology Workshops : Networking Luncheon in Exhibit and Poster Hall
12:30:00 Concurrent Technology Workshops : Networking Luncheon in Exhibit and Poster Hall
13:45:00 Recovery & Purification ; Overcoming the Challenges of the Ton Scale Process (13:45 - 16:00) Brian R. Hubbard, Christopher Teske, Wolfgang Berthold, Michael R. Ladisch
13:45:00 Cell Culture & Upstream Processing (13:45 - 18:00) Bo Kara, Martin S. Sinacore, Susanne Leonhartsberger, Steven C. Peppers, Kevin J. Kayser, Friedrich Srienc, Darrel Menking, David Chang
13:45:00 Scaling Up from Bench through Commercialization : Discussion Begins
13:45:00 Scaling Up from Bench through Commercialization, Discussion Session 4A: Making the Connection: How to Hire, Train and Retain Talent Megan Driscoll
13:45:00 Production & Economics of Biopharmaceuticals ; Scaling Up from Bench through Commercialization (13:45 - 17:30) Sonia Wallman, Megan Driscoll
13:45:00 Overcoming the Challenges of the Ton Scale Process : Chairperson's Remarks Brian R. Hubbard
14:00:00 Plenary Session ; Keynote Presentations and Featured Discussion : Chairperson's Remarks Howard L. Levine
14:00:00 Plenary Session : Keynote Presentations and Featured Discussion (14:00 - 18:00) Howard L. Levine, Michael R. Ladisch, Helen N. Winkle, Fred Larimore, Barry C. Buckland, John Curling, Tobias Massa, Abhinav Shukla
14:00:00 Cell Culture & Upstream Processing : Differential Expression Profiling of Industrially Relevant CHO Cell Phenotypes Using a Proprietary CHO-Specific Microarray and Proteomics Technology Platforms Martin S. Sinacore
14:00:00 Overcoming the Challenges of the Ton Scale Process : Options to Overcome the Current Challenges in Downstream Processing Wolfgang Berthold
14:15:00 Plenary Session ; Keynote Presentations and Featured Discussion : Future of Cell Line and Process Development Barry C. Buckland
14:30:00 Overcoming the Challenges of the Ton Scale Process : Purification Process Development to Increase Capacity in an Existing Manufacturing Facility Christopher Teske
14:30:00 Cell Culture & Upstream Processing : Mammalian Cell Culture Monitoring and Control by Automated Flow Cytometry Friedrich Srienc
14:45:00 Scaling Up from Bench through Commercialization ,Discussion Session 4B: Building the Biomanufacturing Education and Training Infrastructure Sonia Wallman
15:00:00 Cell Culture & Upstream Processing : 20g/L and Beyond: Development of Advanced Expression Solutions for the Manufacture of Biopharmaceuticals Bo Kara
15:00:00 Plenary Session ; Keynote Presentations and Featured Discussion : Interactive Panel Discussion on the Future of Downstream Processing: How Best to Handle Higher Bioreactor Outputs and Greater Product Demands Abhinav Shukla, Alan Klotz, John Curling, Fred Larimore, Michael R. Ladisch
15:00:00 Overcoming the Challenges of the Ton Scale Process : Novel Technologies for Processing High Volumes in Downstream Manufacturing Michael R. Ladisch
15:30:00 Cell Culture & Upstream Processing : Networking Refreshment Break and Last Chance for Poster and Exhibit Viewing
15:30:00 Overcoming the Challenges of the Ton Scale Process : Networking Refreshment Break and Last Chance for Poster and Exhibit Viewing
15:30:00 Scaling Up from Bench through Commercialization : Networking Refreshment Break and Last Chance for Poster and Exhibit Viewing
15:45:00 Plenary Session ; Keynote Presentations and Featured Discussion : Networking Refreshment Break in Exhibit and Poster Hall
16:00:00 Regulatory Guidance, Validation & Viral Clearance : Evaluation of Process and Product Impact of UVC Treatment on a mAb Process R. Scott Rosenthal
16:00:00 Regulatory Guidance, Validation & Viral Clearance (16:00 - 18:00) Yaling Wu, R. Scott Rosenthal, Gail Sofer, Hannelore Willkommen
16:00:00 Cell Culture & Upstream Processing : Development of High Protein Producing Cell Lines from Hybridoma Clones Using Lentiviral Vectors Darrel Menking
16:15:00 Scaling Up from Bench through Commercialization : Discussion Resumes
16:15:00 Plenary Session ; Keynote Presentations and Featured Discussion : Regulatory Modernization Helen N. Winkle
16:30:00 Regulatory Guidance, Validation & Viral Clearance : A Novel Procedure for Validation of Adventitious Virus Removal from a Monoclonal Antibody Process Case Study Yaling Wu
16:30:00 Cell Culture & Upstream Processing :Secretion of Antibody Fragments and Target-Binding Proteins with E. coli Susanne Leonhartsberger
16:45:00 Scaling Up from Bench through Commercialization , Discussion Session 5: Publishing with BPI
17:00:00 Regulatory Guidance, Validation & Viral Clearance : The Importance of Virus Spike Preparation Gail Sofer
17:00:00 Cell Culture & Upstream Processing : Evaluation and Impact of Hydrolysates on Production Yield Improvement David Chang
17:00:00 Plenary Session ; Keynote Presentations and Featured Discussion : Industry Expectations of the New Pharmaceutical Quality Assessment System Tobias Massa
17:30:00 Scaling Up from Bench through Commercialization : Discussion Ends
17:30:00 Regulatory Guidance, Validation & Viral Clearance : European Draft Guideline on Virus Safety Evaluation of Products in Development Hannelore Willkommen
17:30:00 Cell Culture & Upstream Processing: Implementation of High Throughput Systems for Media and Process Development Steven C. Peppers
17:45:00 Plenary Session ; Keynote Presentations and Featured Discussion : Networking Reception and Dedicated Poster Viewing in Exhibit and Poster Hall
18:00:00 Close of Day Three
18:00:00 Close of Day Three
Wednesday, October 3, 2007
07:30:00 Recovery & Purification : Coffee
07:30:00 Cell Culture & Upstream Processing : Coffee
08:00:00 Cell Culture & Upstream Processing : Chairperson's Opening Remarks Laurel Donahue-Hjelle
08:00:00 Recovery & Purification : Chairperson's Opening Remarks: Disposables in Chromatography - The Good, the Bad, and the Ugly Uwe Gottschalk
08:15:00 Improving Downstream Economies and Efficiencies with Disposables, Platforms and Quality by Design (08:15 - 10:45) Jue Michelle Wang, Pranhitha Reddy, Dorothee Ambrosius, Marc Bisschops
08:15:00 Late Stage Process Development - Improving Yield and Quality (08:15 - 12:00) Thomas Jostock, Shawn R. Smith, Kenneth Green, Thomas Seewoester, Gene W. Lee
08:15:00 Improving Downstream Economies and Efficiencies with Disposables, Platforms and Quality by Design : The Role of Primary Recovery TFF in Non-Affinity Purification Schemes for HuMab Production Case Study Jue Michelle Wang
08:15:00 Late Stage Process Development - Improving Yield and Quality : Strategies for Changing Cell Lines and/or Processes During Late Stage Development Thomas Jostock
08:45:00 Late Stage Process Development - Improving Yield and Quality : Industry Perspective on Reducing Lot-to-Lot Hydrolysate Variability Thomas Seewoester
08:45:00 Improving Downstream Economies and Efficiencies with Disposables, Platforms and Quality by Design : Application of Platform Technologies in Downstream Development: Benefits and Limits Case Study Dorothee Ambrosius
09:15:00 Improving Downstream Economies and Efficiencies with Disposables, Platforms and Quality by Design : Impact and Benefits of Applying Quality by Design(QbD) in Cell Line Development to Downstream Process Development Pranhitha Reddy
09:15:00 Late Stage Process Development - Improving Yield and Quality : Panel Discussion, Reducing Hydrolysate Variability - Perspectives from the Suppliers Shawn R. Smith
09:45:00 Late Stage Process Development - Improving Yield and Quality : Networking Refreshment Break
09:45:00 Improving Downstream Economies and Efficiencies with Disposables, Platforms and Quality by Design : Networking Refreshment Break
10:15:00 Late Stage Process Development - Improving Yield and Quality : Development of a Robust Small-Scale Production Format that is Predictive of Bioreactor Performance Gene W. Lee
10:15:00 Improving Downstream Economies and Efficiencies with Disposables, Platforms and Quality by Design : BioSMB: Scaled Down MAb Capture in a Disposable-Format Continuous, Multi-Column Chromatography Process Case Study Marc Bisschops
10:45:00 Late Stage Process Development - Improving Yield and Quality : Title to come
10:45:00 Next Generation Process Control : A Systematic Approach for Process Improvement via Process Data Analysis: Example for Improving UFDF Recovery Efficiency Case Study Michael J. Bartkovsky
11:15:00 Late Stage Process Development - Improving Yield and Quality : The Application of Root Cause Analysis and Investigational Tools to Identify and Resolve Cell Culture Issues Observed at Commercial Scale during Technology Transfer Kenneth Green
11:15:00 Next Generation Process Control : Process Characterization during Development and Validation Steven Walfish
11:45:00 Concurrent Technology Workshops: Preview of a Novel and Robust Viral Clearance Solution from Millipore Mani Krishnan, Sal Giglia, Inese Lowenstein
11:45:00 Concurrent Technology Workshops : Luncheon and Technology Workshop
11:45:00 Concurrent Technology Workshops : Title to come.
11:45:00 Concurrent Technology Workshops: Process Optimization Using Peptones - Case Studies Demonstrating Increased Performance With Peptone Blends and Feed Strategies Stacy Holdread
12:00:00 Commercial Process Readiness, Troubleshooting and Improvements (13:45 - 17:00) Jin Yin, Marion Piquet, Michael Gammons, Eric Fallon, Geoffrey Hodge, Sadettin Ozturk, Nicole Bleckwenn, Carin Gray
12:00:00 Concurrent Technology Workshops (11:45 - 12:15) Mani Krishnan, Stacy Holdread, Inese Lowenstein, Sal Giglia
12:15:00 Integration, Implementation and Validation of Single-use Bioprocessing Technologies Ian Sellick
13:30:00 Recovery & Purification: Chairperson's Remarks Chris Dowd
13:30:00 Cell Culture & Upstream Processing: Chairperson's Remarks Suzanne Kuo
13:45:00 Novel Process Development Strategies (13:45 - 17:00) Paul Baptiste, Diane D. Dong, Peter DePhillips, Daotian Fu, Yuefeng Lu, Robert G. Luo
13:45:00 Commercial Process Readiness, Troubleshooting and Improvements : BioProcessing Challenges for Large Scale Disposable Bioreactors Geoffrey Hodge, Jin Yin
13:45:00 Novel Process Development Strategies : Process Development Strategy for High-Concentration UF/DF of MAbs Robert G. Luo
14:15:00 Novel Process Development Strategies : Accelerating Process Development: Automation of Analytical Assays Peter DePhillips
14:15:00 Commercial Process Readiness, Troubleshooting and Improvements : Comparisons of Product Quality from Disposable and Stainless Reactors Sadettin Ozturk
14:45:00 Novel Process Development Strategies : Exploring "Hot Spots" In Recombinant Monoclonal Antibody Molecules Yuefeng Lu
14:45:00 Commercial Process Readiness, Troubleshooting and Improvements : Efficient Cell Culture Characterization and Validation Studies Using a Scale-down Model for Changes to a Licensed Antibody Process Marion Piquet
15:15:00 Commercial Process Readiness, Troubleshooting and Improvements : Networking Refreshment Break
15:15:00 Novel Process Development Strategies :Networking Refreshment Break
15:30:00 Commercial Process Readiness, Troubleshooting and Improvements : A Custom Developed Integrated Bioreactor Control and Data Management System for Process Development - Leveraging Information from Early Stage Process Development through Commercial Manufacturing Case Study Michael Gammons, Nicole Bleckwenn
15:30:00 Novel Process Development Strategies : Humira After Launch - Opportunities and Challenges in Downstream Process Diane D. Dong
16:00:00 Novel Process Development Strategies : Use of Complex Analytical Methods to Support Process Development Daotian Fu
16:00:00 Commercial Process Readiness, Troubleshooting and Improvements : Characterization of the Operating Parameters for the WAVE Bioreactor Expansion Stages of a Commercial Scale Cell Culture Production Process Carin Gray
16:30:00 Novel Process Development Strategies : Evaluation of Conformation and Bioactivity of a Monoclonal Antibody Product as a Function of Time and pH Following Protein A Chromatography Paul Baptiste
16:30:00 Commercial Process Readiness, Troubleshooting and Improvements : Data Mining with Avastin® for Process Improvements and Optimization Case Study Eric Fallon
17:00:00 Commercial Process Readiness, Troubleshooting and Improvements : Close of Conference
17:00:00 Novel Process Development Strategies : Close of Conference
4th Annual Pharma R&D Asia Congress
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