Informa

Event Highlights

Preliminary Agenda Highlights

Examine the Entire Bioprocessing Spectrum Across Five Concurrent Content Tracks

Customize your BPI experience by choosing presentations most relevant to your line of work, or attend one of the five tracks in its entirety for a deep dive in a specific focal area.

Keynote Presentations

Improving Global Access to Biotherapeutics through Molecule, Process and Manufacturing Design

Dean K. Pettit, Ph.D., CSO and Founding Partner, Just Biotherapeutics

Tools for Mapping and Repairing Disease States: Can We Make Therapeutic Invention into a Mature Design Science?

Ed Boyden, Ph.D., Associate Professor, Media Lab and McGovern Institute, MIT

Pre-Conference Symposia

Continuous Processing
Vaccine Development and Production: Novel Technologies and Strategies
Biosimilar Development and Production
Modern CMC Regulatory Strategies and Insights
Advanced Control Strategies in Bioprocessing and Biomanufacturing: Disruptive Technologies and Emerging Platforms for Biologics Facilities of the Future
Cell-Based Immunotherapies

Two-Day Training Courses

CMC Analytical, Comparability and Stability Studies

Instructor

  • Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC
Introduction to Biopharmaceutical Manufacturing

Instructors

  • Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants
  • Frank Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants 

Manufacturing Strategy Track

Next Generation Automation Enhances Single-use Process Platforms

Miriam Monge, Director of Marketing Integrated Bioprocess Solutions, Sartorius Stedim Biotech 

Thorsten Peuker, Ph.D., Vice President, Integrated Solutions Sartorius Stedim Biotech

Strategies and Best Practices for Management, Assessment and Implementation of Raw Material and Manufacturing Changes to Filters and Chromatography Resins

Bernd Kraemer, Ph.D., Head Supplier Quality Management Americas, Genentech

A Technology Roadmapping Process to Transform the Biopharmaceutical Manufacturing Industry

Udayanath Aich, Ph.D., Principal Scientist, Sanofi-Genzyme

Pitfalls of Back to Back Technology Transfers From an Established DS Manufacturing Production Site to a Non-Licensed Facility

Lisa Day, Engineer, Manufacturing Sciences, Genentech

Case Study Using Bio-Analytical Comparability for Licensure of a Vaccine Manufacturing Facility

Indresh Srivastava, Ph.D., Vice President, Process & Analytical Development, Senior Program Manager - Influenza, Protein Sciences Corporation

Case Study: Accelerated Late Phase Process Development and Transfer of a Mab Manufacturing Process

Kathryn Aron, Senior Scientist, Process Development, Bristol-Myers Squibb

Manufacturing Case Study in Raw Material and Storage Conditions

Bunyada Kwong, Engineer II, Manufacturing Sciences, Cell Culture, Genentech

Advanced Manufacturing Progress and Impact on US National Security

R. Thomas Warf, Director, Manufacturing, Facilities and Engineering, BARDA

Jean Hu-Primmer, Senior Advisor for CBRN and Pandemic Influenza, Office of Counterterrorism and Emerging Threats, US Food & Drug Administration

Integration of Technology Transfer and Site Readiness to Ensure Successful Production Campaign

Chiali Liu, Ph.D., Principal Scientist, Technical Operations, Janssen Supply Chain

Rapid Prototyping Applications to Support Technology Transfers in the Commercial Manufacturing Environment

Andy Norriss, Senior Engineer, Materials Science, Genentech, Inc.

Choosing the Right Biomanufacturing Strategy: Decision Points and Development Path Considerations

Steve Lam, Senior Vice President, Biologics, Patheon

Functional Collaborations to Successfully Validate a Mab Process at a Contract Manufacturing Site

Harish Santhanam, Associate Engineering Advisor, Biotech Manufacturing, Eli Lilly, Ireland

Overview of Current Drivers of Vaccine Manufacturing Development from Facility, Technological, Regulatory and Analytical Perspectives

Joshua Speidel, Ph.D., Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc.

Vaccine Delivery and Device Innovation

Darin Zehrung, Senior Technical Officer & Portfolio Leader, Vaccine and Pharmaceutical Delivery Technologies, PATH

Enabling Flexibility in Supply Chain and Product Presentation through Bulk Powder Drug Substance Manufacturing of Biologics

Kapil Gupta, Ph.D., Associate Director, Protein Pharmaceutical Development, Biogen

Closed Systems in CNC Ballroom, A Risk Based Approach

Lars Hovmand-Lyster, Senior Engineering Specialist, Global Project Office, Novo Nordisk

Effectiveness of Raw Material Purity in Drug Product Manufacturing

Speaker TBA, Avantor

Control of Raw Materials, Processes, Extractable and Particles Improves Single Use Compatibility with Biologics  

Jean-Marc Cappia, Group Vice President Marketing & Product Management, Sartorius Stedim Biotech, France

Complex Resolution of a Product Quality Issue for a Commercial Product

Peter Wojciechowski, Ph.D., Head, Process Investigation and Innovation, Shire

PANEL DISCUSSION: The Future of Vaccine Antigen Manufacturing

Panelist: Mario Barro, Ph.D., Senior Director, Innovation, Sanofi Pasteur

PANEL DISCUSSION: Global Health Vaccine Manufacturing Challenges: Innovation to Support Reduced Cost of Goods

Subhash Kapre, Ph.D., CEO, Inventprise Bas du formulaire

Drug Product, Fill Finish & Formulations Track

Unexpected Findings Discovered during the Formulation Development of a Freeze-dried Ebola-Expressing Adenoviral Vector (ChAd3-EBOZ)

Frederic Mathot, Ph.D., Senior Scientist, Drug Product R&D - Global Vaccines Technical R&D, GlaxoSmithKline Vaccines, Belgium

Case Studies Demonstrating Challenges, Solutions, and Process Improvements Associated with the Drug Product Manufacturing Process of Biopharmaceuticals

James Colandene, Ph.D., Manager, Biopharmaceutical Product Sciences, GlaxoSmithKline

Satisfying Very-high Dose Needs of Biologics: Ultra-high Concentration Formulation Development, Manufacturing and Delivery

Vineet Kumar, Ph.D., Principal Scientist, Drug Product Development, Johnson and Johnson

Particulate Formation During Product End-use: Characterizing Nano- and Sub-visible Particles

Vivek Kumar Garripelli, Ph.D., Senior Scientist II, Biologics Formulation Development, AbbVie

Unexplored Benefits of Controlled Ice Nucleation during Lyophilization

Shubhadra Singh, Ph.D., Investigator, Biopharm Product Sciences, GlaxoSmithKline R&D

Quantify Pressure Distribution in the Filling Line - Pressure Analysis by In-Line Monitoring

Edwin Vilanova Velez, MSAT Engineer, Finished Goods, Genentech

Case Studies on the Impact of Changes of Drug Substance on Final Fill-finish Product

Shen Chen, Ph.D., Director, PEH Pharm Sci, Pfizer CentreOne R&D

A Practical Approach for Assessing the Impact of Visible and Ultraviolet Radiations on Biomolecules

Ganapathy Gopalrathnam, Principal Research Scientist, Lilly Research Laboratories, Eli Lilly and Company

PANEL DISCUSSION: How to Mitigate Drug Product Technical Challenges

Panelists TBA

Criticality of Equipment Design on Protein Product Quality during Drug Product Manufacturing: A Case Study

Benson Gikanga, Engineer II, Pharmaceutical Processing and Technology Development, Genentech

Bulk Freezing in Shelf-Life Extension and Drug Product Manufacturing

Mark Yang, Ph.D., Director of Fill Finish Development, Pharma Development Biologics, Sanofi

Enabling Flexibility in Supply Chain and Product Presentation through Bulk Powder Drug Substance Manufacturing of Biologics

Kapil Gupta, Ph.D., Associate Director, Protein Pharmaceutical Development, Biogen

A Risk-Based Process Control Strategy for Low Endotoxin Drug Product Manufacturing

Robert Simler, Associate Director, Biogen

Analytical & Quality Track

Evaluation of Analytical Methods for High-throughput Glycan Analysis

Ashley Wilson, Development Associate III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

Advances and Challenges in the Analytical Characterization of Biosimilar Products

Jeff Allen, Ph.D., Biosimilar Sciences Fellow, Pfenex

Development of Multiplex Sensitive Anti-drug-antibody (ADA) Assays for CRISPR/Cas9 Genomic Medicines

Junxia Wang, M.D., Ph.D., Associate Director, Immunosafety and Bioanalytical Development, Editas Medicine

PANEL DISCUSSION: In-country Release Testing and Method Transfer

Panelist: Melissa Morandi, Vice President, Global Quality, Aegerion Pharmaceuticals 

Transforming Deviation Management using a Proven Risk Based Approach 

Brian Chviruk Associate Director of Investigations, Production Technical Support, Shire

Jay Antonetti, Associate Director of Quality Assurance, Sanofi

Analytical Comparability Strategies for Biosimilars

Anna Schwendeman, Ph.D., Assistant Professor, Pharmaceutical Sciences, University of Michigan

Monitoring of Methionine Oxidation in Antibody-drug Conjugates (ADCs) by UV-UPLC

Alexandra Zaitsev, Development Associate II, Analytical & Pharmaceutical Sciences, ImmunoGen, Inc.

Particulate Formation During Product End-use: Characterizing Nano- and Sub-visible Particles

Vivek Kumar Garripelli, Ph.D., Senior Scientist II, Biologics Formulation Development, AbbVie

Multi-attribute Monitoring

Rich Rogers, Scientist, Just Biotherapeutics

Analytical CMC Considerations for Biotherapeutics

Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

Multi-Variate Data Analysis and its Potential Contribution to Quality

Randall Kilty, Technology Scientist/Process Engineer, Pfizer

General Strategies for Characterization of Subvisible Particles(SVP) Based on Product Specific SVP Library

Yu Hayashi, Researcher, Astellas Pharma, Japan

Potential Impact of Nano Particulate Impurities from Sugars on Therapeutic Proteins

Anant Sharma, Formulation Scientist, Eli Lilly & Company

Integrating Novel Analytical Tools into Development Workflow of Biologics: nanoDSF and MST for Discovery, Development and QC

Alexey Rak, Ph.D., Head of Bio Structure and Biophysics, Sanofi R&D, France

Specifications and Change Control across the Product Lifecycle

Melissa Morandi, Vice President, Global Quality, Aegerion Pharmaceuticals

Nanofluidic Device Enabling Real-time Product Quality Assessments in Biomanufacturing System

Sung Hee Ko, Ph.D., Postdoctoral Fellow, Massachusetts Institute of Technology

Phase-appropriate Approaches to Streamlining Bioassay Testing

Tariq Warsi, Ph.D., Senior Scientist, Process Development. Amgen

Recovery & Purification Track

Virus Filtration: Throughput Comparison of Commercial Filters and Development of New Prefiltration Strategy

Dr. Abhijit Shrike, Scientist, Teva Pharmaceuticals

Evaluating Novel Harvest Methods for High Density Cell Culture Processes

Mahsa Rohani, Scientist, Amgen

A Comprehensive Regeneration Strategy for Protein an Affinity Resin in Monoclonal Antibody (mAb) Purification

Lu Wang, Senior Scientist, Teva Pharmaceuticals

Multi-target Approach to Affinity Purification of Recombinant Proteins

Andrew Keefe, Senior Downstream Development Engineer, Shire

Reduction of Process Related Impurities in Ocular Therapeutics

Nicole Lee, Sr. Research Associate, Genentech Inc

Selectivity Analysis of Multimodal Cation-Exchange Chromatography on Protein Impurity Separation

Keith Selvitelli, Senior Associate Scientist, Biogen

Removal of CHO Protein - Phospholipase B-Like 2 (PLBL2) during Downstream Processing of a Monoclonal Antibody

Mukesh Mayani, Scientist II (Process Development), Bristol-Myers Squibb

Purification Process Development for a Light-Sensitive Monoclonal Antibody

Nathaniel Macapagal, Scientist I, Medimmune

Characterization of a Recombinant Enzyme Downstream Process Using Modern DOE Techniques

Michael Coolbaugh, Scientist, Sanofi

Optimization of Manufacturing Operations and Timelines Driven Through the Pilot Scale Plant

Douglas Osborne, Senior Manager, Biogen

Impact of Depth Filtration on Monoclonal Antibody Interchain Di-Sulfide Bond Stability during Downstream Processing from CHO Cell Cultures

Manju Kuruganti, Scientist, Bristol-Myers Squibb

Acoustic Wave Separation as a Novel Clarification Technique for the Removal of Aggregate-Enriched Calcium Phosphate Precipitates during Bispecific Antibody Purification

Lindsay Arnold, Scientist, MedImmune

The Link between Protein A Eluate Turbidity and Virus Filtration Fouling

Robert Duffy, Principal Scientist, AbbVie

Flow-through Versus Bind-and-Elute: an Alternative Strategy for Improved Robustness and Manufacturability for a Challenging Cation Exchange Chromatography

Jessica Prentice, Associate Scientist, MedImmune


Cell Culture & Upstream Processing Track

How to Measure and Harness CHO Cell Genetic/Functional Instability for Improved Cell Factory Performance

Dr. David Jones, Professor of Bioprocess Engineering, University of Sheffield

Optimization of Manufacturing Operations and Timelines Driven Through the Pilot Scale Plant

Douglas Osborne, Senior Manager, Biogen

A Novel Integrated End-To-End Workflow System Supporting High Throughput Cell Line and Scale-Down Upstream Process Screening   

Christoph Freiberg, Senior Scientific Consultant, Genedata

Improving Antibody Titers through Media and Process Improvements, While Maintaining Product Quality Attributes

Wei Gu PhD., Group Leader, Upstream Process Development, Morphotek Inc.

Evaluating the Effect of Poloxamers on DNA Transfection Methods

Rachel Fergeson, Associate Scientist, Biogen

Evaluate Thermo 30L Single Use Bioreactor for Seed Train and Inoculum Train

Edward Chan, Technical Engineer II, Genentech, Inc

Scale-down Model of N-1 Perfusion Seed Bioreactor for High-Throughput Analysis

Yongqi Wu, Scientist, Bristol-Myers Squibb

A Fresh Approach to Process Characterization Through the Use of New Tools and Technologies

Rita Barros Costa, Senior Group Leader, Lonza Biologics

How to Measure and Harness CHO Cell Genetic/Functional Instability for Improved Cell Factory Performance

David James, Professor of Bioprocess Engineering, University of Sheffield

Interface Between Upstream & Downstream Processing

How Low Can We Go; Application of Multimodal Cation Exchange Chromatography for Reduction of HCP and High Molecular Weight Species for Non-IgG Purification

Zahira Begum, Senior Research Associate, Genentech Inc.

Leverage Partnership, Technical Development and Manufacture to Deliver Next Generation High Titer Biologics Production

Haofan Peng, Senior Engineer II, Biogen

Accelerating Upstream Process Characterization using Efficient Experimental Designs

Karna Shah, Manufacturing Sciences, Cell Culture, AbbVie Research Center


Risk-Based Approaches for Developing Product Control Strategies for Biologics Programs

Jonah A. Kaplan, Senior Scientist, AbbVie

DOE Study for Recombinant Protein Production by CHO Clone and Integration of Qbd during Bioprocess Optimization

Khandaker Siddiquee, Senior Scientist, Abbott Laboratories

Use of Novel Spiral Separators for the Continuous Capture of Monoclonal Antibodies Using Protein A Resins

Andrew Zydney, Distinguished Professor, The Pennsylvania State University

Manufacturing with InSCyT: Rapid End-To-End Production of Protein Biologics

Kerry Routenberg Love, Research Associate and Technical Program Manager, DARPA InSCyT Program