Boston, MA

The #1 BioProcessing Event in the Industry

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BioProcess International Conference & Exhibition

Conference: October 20-23, 2014 * Exhibition: October 21-23, 2014 * John B Hynes Veterans Memorial Convention Center, Boston, MA

1,500+ Attendees - 200+ Speakers - 150+ Exhibitors

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Pall Life Sciences

Thermo Scientific

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THE Industry Meeting Place to Exchange Real-World Solutions to Improve Speed, Cost and Quality

Conference: October 20-23, 2014 · Exhibition: October 17-19, 2014 · John B Hynes Veterans Memorial Convention Center · Boston, MA

Preliminary Confirmed Speakers

Preliminary Confirmed Speakers

Cell Culture & Upstream Processing

Development of Transient Expression System Based in CHO
Gavin Barnard, Ph.D., Senior Research Scientist, Biotechnology Discovery Research, Lilly Research Laboratories

Implementation of Frozen Seed Train Intermediate to Initiate CHO Cell Culture Manufacturing Campaigns Quickly and Efficiently
Jason Goodrick, Senior Engineer, Late Stage Cell Culture, Genentech

From Gene to Manufacturing: Application of Efficient Strategies During Development to Deliver Reliable, High Quality Biomanufacturing Processes
Alison Porter, Head of Mammalian Cell Culture R&D, Fujifilm Diosynth Biotechnologies

Progress towards Efficient Implementation of Continuous Upstream Processes in Early Development
Daryl Powers, Sanofi

mAbs for the Multitude by Automated Continuous Processing Enabled by Single Use
David Pollard, Executive Director, BioProcess Development, Merck & Co Inc.

Biomanufacturing Using Solely SU Technologies - Case Study and Cost Comparisons with a SS Facility
Venkatesh Natarajan, Ph.D., Senior Process Engineer III, Global Engineering Sciences, Biogen Idec

UNICAN: Dual Capability in Single Use Bioreactor
Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech

Commercial Applications of Disposables
Jonathan Blackie, Senior Director of Manufacturing, BioMarin Pharmaceutical, Inc.

Cell Culture Small Scale Model Development for a Commercial Legacy Process
Hunter Malanson, Development Associate IV, Upstream Development, Alexion Pharmaceuticals

How to Identify and Manage Risk Associated with Materials
Kenneth Green, Pfizer

Understanding the Influence of Cell Culture Medium Composition and Process Parameters on Charge Variant Heterogeneity of Recombinant Antibodies
Kartik Subramanian, Manufacturing Sciences, Cell Culture, Abbvie Bioresearch Center

Influence of Trace Metals Concentration in Cell Culture Media on Process Performance and Product Quality
Anil Raghani, Principal Scientist, Process & Product Development, Amgen Inc.

Recovery & Purification

Decoupled Upstream and Downstream (Using SPTFF and Single Use Bulk Freezing Technology) to Improve Manufacturing Flexibility
Alex Brinkmann, Biogen Idec

Developing a Multi-Ton Antibody Production Process - Aggregate and Host Cell Reduction Challenges and Facility Fit
Christopher Teske, Ph.D., Senior Engineer, Purification Development, Genentech, Inc.

Emerging concepts in process characterization for host cell proteins: Potential impact on biosimilars and biotech products
Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts

Sequence Variant Analysis and Control of a Recombinant Monoclonal Antibody Therapeutic
Connie Lu, Ph.D., Senior Scientist, Global Method Management and Technology, Genentech, Inc.

Development and Process Characterization of a Precipitation Step using Sodium Caprylate for the Reduction of Host Cell Proteins
Jessica Prentice, Associate Scientist II, Purification Process Sciences, MedImmune

High-Throughput Screening for Profiling of Non-Antibodies Using Disposable Technologies
Amitabha Deb, Fellow, Integrated Biologics Profiling Group, Novartis Pharma

Development of Robust Wash Conditions for Protein A Capture Chromatography using High-Throughput Automation Technologies
Srinivas Chollangi, Ph.D., Scientist, Biologics Development, Bristol-Myers Squibb

Design and Optimization of Countercurrent Tangential Chromatography for Monoclonal Antibody Purification
Andrew Zydney, Professor and Department Head, Chemical Engineering, The Pennsylvania State University

Affinity Purification for Improved Process Understanding and Decision-Making in Bioprocess Development for Enzymes
Venkat Ryakala, Process Engineer, Purification Development, Genzyme, A Sanofi Company

Leveraging Mixed Mode Chromatograghy for Purification of Bispecific Antibodies
Carsten Voss, Bio-Rad

Analytical & Quality

Assessment of Higher Order Structure Techniques (CD, FTIR and NMR) for Characterization and Comparability of Monoclonal Antibodies
Jasper Lin, Ph.D., Associate Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

Investigation of Glycan-Structure Function Relationship of an IgG1 using In Vitro Glycoeningeering
Marco Thomann, Manager Development Analytics, Roche Diagnostics GmbH, Germany

Particulates Monitoring and Control Strategy for Protein Therapeutics
Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems, a Wholly-Owned Subsidiary of Eli Lilly & Co.

Emerging Concepts in Process Characterization for Host Cell Proteins: Potential Impact on Biosimilars and Biotech Products
Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts

Sequence Variant Analysis and Control of a Recombinant Monoclonal Antibody Therapeutic
Connie Lu, Ph.D., Senior Scientist, Global Method Management and Technology, Genentech, A Member of the Roche Group

Discovery of a Novel Protein Modification to a Recombinant Monoclonal Antibody
Chris Chumsae, Process Sciences, Protein Analytics, Abbvie Bioresearch Center

High Throughput Screening and Early Analytics to Assess Drug-like Properties and Manufacturability
Patricia Lowden, Scientist II, Eleven Biotherapeutics

High-throughput Protein Covalent Aggregation Measurement by Automated Simple Western Blot System Using Cell Culture Material
Janet Lau, Ph.D., Scientist I, Cell Culture Development, Biogen Idec

Highthroughput Characterization and Stability of Biologics
Leena Philominathan Ph.D., Scientist, Analytical Sciences, Alexion Pharmaceuticals

Elucidating the Structure/Function Relationships of Complex Glycoproteins (non-mAbs)
Johnson Varghese, Ph.D., Senior Director/Head, Analytical Development, Shire

Complex Glycoprotein Analysis: Mass Spectrometry-based Approaches
Tao He, Ph.D., Associate Research Fellow, Global Biotherapeutic Technologies, Pfizer

In vitro Assay Platforms to Assess the Biological Function of Enzymes
Peter Bernhardt, Ph.D., Senior Scientist, Analytical Development, Rare Disease Business Unit, Shire

Recombinant Protein-therapeutics: Structure-activity Relationship Studies In-vitro and Beyond
Yelena Lyubarskaya, Ph.D., Senior Principal Scientist, Analytical Development, Biogen Idec, Inc.

Structure-Function Relationships in Therapeutic Sulfatases
Bill Prince, Ph.D., Executive Director, Analytical Chemistry & Formulation, BioMarin Pharmaceutical

Testing Strategy as a Holistic approach: Risk-based Optimization for In-process, Release and Stability Testing
Alla Polozova, Scientist, Amgen

Biosimilar Characterization
Roxanna Butoi, Scientist, GlaxoSmithKline

Case Study: Increasing Efficiencies by Moving Analytics to the Manufacturing Floor
Michael Thomas, Director, Manufacturing, Amgen

Microbial Control: What's Bugging You?
Sarah Thomas, Site Quality Director, GSK Rockville, GlaxoSmithKline

Strategies for Continued Process Monitoring of Commercial Cell Culture and Purification at Large Scale
Pawel Drapala, Ph.D., Senior Process Engineer, Technical Manufacturing Services, Alexion Pharmaceuticals, Inc.

The Validity of Quality Risk Assessments and the Importance of Framing
Joseph A. Horvath, Ph.D., Senior Director, Quality Systems, Takeda Pharmaceuticals International

Application of QbD Concepts to Legacy Products
Elsie DiBella, Ph.D., Director, Manufacturing Sciences, Shire

Biologics Manufacturing Strategies

The Evolving Landscape of Biomanufacturing
Randy J. Maddux, Vice President & Site Director, GlaxoSmithKline

Biomanufacturing Strategies to Prepare for the Pipeline of the Future
Philippe Alexandre Gilbert, Scientist, Novartis

Supporting the "Facility of the Future" Concept: Closed Systems Operation and Disposables as Tools
Berthold Boedeker, Chief Scientist, Bayer Healthcare AG, Germany

Capacity, Technology and Innovation Trends in a High Variety Product Portfolio World
Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom

Continued Process Verification: A Model Plan Based on Cross-Industry Knowledge
Bert Frohlich, Director of Bioengineering, Shire

Supply Chain Collaboration, Transparency and Mutually Beneficial Relationships
Matthew Muldoon, Sourcing Manager, Strategic Sourcing Raw Materials & Medical Devices, Bayer HealthCare LLC

Overcoming Technical Challenges while Transferring an Updated Commercial Production Process into Manufacturing
Rick St. John, Ph.D., Senior Group Leader, Purification Development, Genentech, Inc.

Challenges during Scale Down and Up of E.coli Processes
Britta Krampe, Ph.D., Process Engineering Manager, Roche, Germany

Biomanufacturing Using Solely SU Technologies - Case Study and Cost Comparisons with a SS Facility
Venkatesh Natarajan, Ph.D., Senior Process Engineer III, Global Engineering Sciences, Biogen Idec

UNICAN: Dual Capability in Single Use Bioreactor
Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech

Commercial Applications of Disposables
Jonathan Blackie, Senior Director of Manufacturing, BioMarin Pharmaceutical, Inc.

Town Hall Forum: Standardization of Single-Use Systems: What is the Next Step for the Industry?

  • Moderator: James Dean Vogel, Founder and Director, The BioProcess Institute
  • BPSA Perspective: Jerold Martin, Senior Vice President, Global Scientific Affairs, Pall Life Sciences
  • ASME BPE Perspective: Jay Ankers, Director of Technology, M+W Group
  • PDA Perspective: Bob Repetto, Senior Director, External Affairs, Pfizer
  • ASTM Perspective: Robert Steininger, Senior Vice President, Manufacturing, Acceleron Pharmaceuticals, Inc.
  • USP Perspective: Dennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corporation

Challenges and Considerations around Relaxing Environmental Controls in Biopharmaceutical Facilities

  • Moderator: Kristin Murray, Associate Director, GCMC Regulatory Affairs, Pfizer
  • Moderator: Stephen Reich, Director, Quality Systems & Compliance, Pfizer
  • Jeffrey Skene, Ph.D., Acting Chief, Monoclonal Antibodies Division, Health Canada
  • Marc Pelletier, Ph.D., Director of Biotechnology, CRB Consulting Engineers
  • Alex Tschumakow, Director of Manufacturing, Shire
  • Joel Gates, Director of Quality Assurance, Shire
  • Anastasia Lolas, President, Visionary Pharma
  • Paul Smock, Sr. Director, QA, MedImmune

Formulation & Drug Delivery

Assessment of Higher Order Structure Techniques (CD, FTIR and NMR) for Characterization and Comparability of Monoclonal Antibodies
Jasper Lin, Ph.D., Associate Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

Investigation of Glycan-Structure Function Relationship of an IgG1 using In Vitro Glycoeningeering
Marco Thomann, Manager Development Analytics, Roche Diagnostics GmbH, Germany

Particulates Monitoring and Control Strategy for Protein Therapeutics
Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems, a Wholly-Owned Subsidiary of Eli Lilly & Co.

Photodegradation of Therapeutic Proteins under Drug Product Manufacturing Relevant Light Conditions
Li Yi, Ph.D., Technical Development Scientist, Genentech, A Member of the Roche Group

Formulation Robustness Studies for a High Concentration Antibody Product
Xiaofeng Lu, Ph.D., Principal Research Scientist, Abbvie Therapeutics Inc.

Insight into a Complex Degradation profile: Sometimes the Obvious Answer Isn't the Right Answer
Rachel Castell, Scientist II, Formulation Sciences, MedImmune, United Kingdom

High Throughput Screening and Early Analytics to Assess Drug-like Properties and Manufacturability
Patricia Lowden, Scientist II, Eleven Biotherapeutics

High-throughput Protein Covalent Aggregation Measurement by Automated Simple Western Blot System Using Cell Culture Material
Janet Lau, Ph.D., Scientist I, Cell Culture Development, Biogen Idec

Highthroughput Characterization and Stability of Biologics
Leena Philominathan Ph.D., Scientist, Analytical Sciences, Alexion Pharmaceuticals

A Holistic Approach to Early Preformulation and Developability Studies Can Inform and Speed up Later HCLF and Process Development Work
Mark Krebs, D.Phil., Senior Scientist, Protein Pharmaceutical Development, Biogen Idec

Use of Intrinsic Viscosity to Determine Antibody-antibody Interactions and How this Parameter Predicts Liabilities Such as Phase Separation and Aggregation
R. Joe Carrillo, Preformulation, Abbvie Bioresearch Center

Case Study of Phase-Appropriate Formulation Development for Late Stage Molecules
Angela Blake-Haskins, Ph.D., Manager, Biopharma, Drug Product Sciences Department, GlaxoSmithKline

Innovative Characterization Methods to Identify an Optimal Vaccine Drug Product Formulation
Patrick Ahl, Ph.D., Assistant Principal Scientist, Vaccine Drug Product Development, Merck Research Labs

Biophysical Characterization of Flublok, a Recombinant Hemagglutinin (rHA) Influenza Vaccine, by Differential Scanning Fluorimetry
Erin Matthews, Ph.D., Group Leader, Analytical Development, Product Realization, Protein Sciences Corporation

DoE HTP Plate-based Antibody Drug Conjugation Formulation Screen for Optimal Buffers and Excipients: Accelerated Stability Characterization of Physical and Chemical Stability
Stanley Kwok, Ph.D., Senior Scientist, Formulations, Fill/Finish, Seattle Genetics

Formulation Perspectives of Therapeutic Peptides
Ana Santos, Ph.D., Formulation Senior Scientist, Biopharmaceutical Development, Medimmune, United Kingdom

Formulations for Drug-device Combination Products
Sujit Basu, Ph.D., Head, Drug and Combination Products, Global Technical Operations, Shire

Knowledge Management across the Process and Process Lifecycle

Risk-Analysis and Knowledge Management: New Tools and Approaches for the Bio/Pharma Industries
Jose Menezes, Ph.D., Professor, Institute for Biotechnology & Bioengineering, Technical University of Lisbon, Portugal

Knowledge Management and Process Understanding: Putting the Pieces Together
Joseph A. Horvath, Ph.D., Senior Director, Quality Systems, Takeda Pharmaceuticals International

A State-of-the-art Information Management System to Improve Bioprocessing Knowledge Management and Decision-making
Andreas Schneider, Vice President, International Business Leader Custom Biotech, Roche Diagnostics International Ltd., Switzerland

The Needle in the Haystack: Actionable Insight Gleaned from Historical Data Improves Commercial Enzyme Product Output
Rick Baggio, Ph.D, Senior Process Engineer, Therapeutic Manufacturing and Development, Genzyme Corporation, a Sanofi Company

Success Factors for Early Stage Biologics and Early Stage Companies: Moving Quickly to IND and Beyond

Efficient Biologics Lifecycle Development - Maximizing Value while Reducing Risk, Time, and Cost
Mark Moody, Ph.D.,, Biopharma Consultant and former Vice President, Merrimack Pharmaceuticals

Getting More Done with Less: Case Study of an Early Stage Company
Neil Schauer, Senior Vice President, Technical Operations, Avaxia Biologics

Case Study: Getting the Required CMC Studies Done, Balancing Time and Resources with Regualtory Expectations
Paul Giannasca, Ph.D., Vice President of Development, Genocea Biosciences, Inc.

Panel Discussion: Identifying and Integrating Critical Early Development Activities to Enable Successful Progression from Discovery to First-in-human Clinical Trials
Moderator: Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants, Inc.

The Massachusetts Accelerator for Biomanufacturing: A cGMP-like Manufacturing Opportunity for Early Stage Companies
Paul Vigeant, Professor, University of Massachusetts, Dartmouth (Invited)

Single-Use Applications for Biopharmaceutical Manufacturing
BDP Week

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