the only phase-based event to break down silos for … · 2017-01-10 · the only phase-based event...

THE ONLY PHASE-BASED EVENT TO BREAK DOWN SILOS FOR ACCELERATING BIOLOGICS FROM EARLY STAGE PROCESS DEVELOPMENT TO COMMERCIAL MANUFACTURING

February 27 - March 2, 2017Hilton San Francisco Union SquareSan Francisco, CA

Event Partners:

Register by January 13 to Receive a $300 Savings

800+ Global BioProcessing Professionals

100+ Presentations

80+ Exhibitors

40+ Posters

Register by January 13 and Receive a $300 Savings www.BioprocessWest.com

For up-to-date program information, visit: www.BioprocessWest.com 2

EARLY STAGE PROCESS DEVELOPMENT & CLINICAL MANUFACTURING TRACK

LATE STAGE PROCESS DEVELOPMENT & COMMERCIAL LAUNCH PREPARATION TRACK

COMMERCIAL MANUFACTURING & BEYOND

NEW! SINGLE-USE/ FLEXIBLE FACILITIES TRACK

NEW! VIRAL CLEARANCE & SAFETY TRACK

UNIQUE PHASE-BASED FORMAT TO ACCELERATE PRODUCT DEVELOPMENT

The BPI West 2017 agenda format is designed to break down silos across multiple departments that work in the same stage of development. With concurrent tracks focused on early stage process development through commercial manufacturing, attendees can collectively share challenges and discuss the solutions needed to improve the speed, cost and quality of biologics development.

Advance promising biologics from early stage process development to IND by learning how industry leaders reduce timelines, lower costs, develop robust cell lines, and utilize new technologies in downstream processing.

Ensure your product is ready for market launch by applying global best practices for process validation, raw material sourcing, process robustness, process simplification and scale-up manufacturing.

Create a sustainable commercial manufacturing program by applying innovating strategies for capacity improvements, supply chain continuity, lifecycle management and operational efficiencies.

Accelerate development for multi-product pipelines, global markets and capacity optimization by meeting requirements for validation, supply chain, design and operational considerations.

Ensure regulatory compliance by applying new technologies and strategies in viral risk mitigation in upstream processing and downstream viral clearance.


GAIN THE SCIENCE, TECHNOLOGIES AND CONTACTS YOU NEED TO ACCELERATE YOUR PROMISING BIOLOGICS TO MARKET

THE LEADING SCIENCE

THE MOST INNOVATIVE TECHNOLOGY

The scientific agenda offers 100+ speaker presentations designed to improve the speed, cost and quality of your process development and manufacturing efforts. Our large, multi-track format presents innovative scientific developments, industry updates and technology applications across the entire bioprocessing spectrum from early stage process development through commercial launch preparation.

The exhibit hall gathers 80+ exhibitors representing global CMOs, CROs, suppliers and technology leaders who can help your company accelerate your product to market. See live product demonstrations and discuss your needs with knowledgeable vendors from all over the world.

THE RIGHT PARTNERS FOR YOU

Whether you are looking to meet potential customers or partners, BPI West is the one-stop shop to network with global scientists and decision makers working across all aspects of the biopharmaceutical field. Networking luncheons, poster viewing hours and evening cocktail receptions offer simple yet effective opportunities. Plus, your registration includes access to our digital partnering app, allowing you to view the entire attendee list and schedule meetings before, during and after the event.

Priorities in Global Healthcare and Burden of Disease: Are We Doing the Right Things in Biopharma and Vaccines?

Drivers in Innovation and How Biosimilars Will Increase Price Pressures and Drive Innovation and Intensification

Jens Vogel, Ph.D. President and CEO Boehringer Ingelheim Fremont

Development & Manufacturing of Exosomes - A New Therapeutic Modality with Tremendous Potential

Konstantin Konstantinov, Ph.D., Senior Vice President Manufacturing & Process Sciences Codiak Bioscience

Günter Jagschies, Ph.D. Senior Director GE Healthcare Life Sciences

INDUSTRY EXPERTSPRESENT STRATEGIES FOR ACCELERATED PRODUCT LAUNCH

Register Early for Best Savings • www.BioprocessWest.com • 888-670-8200 4

AGENDA AT-A-GLANCEMonday, February 27, 2017 • Pre-Conference Symposia

1:00-5:00 Continuous Processing Biosimilars - From Early Stage Development to Commercialization

Filling the Bioprocessing Toolbox with Novel Tools and Technologies Development and Production of Cell & Gene Therapies

9:30 – 3:00 Site Tour: CHT™ Ceramic Hydroxyapatite Process Column Packing Workshop Sponsored by Bio-Rad

Tuesday, February 28, 2017 • Main Conference Exhibit Hall & Poster Viewing Hours: 3:15 to 6:30 pm

Single-Use Early Stage Process Development & Clinical Manufacturing

Late Stage Process Development & Commercial Launch Preparation

Commercial Manufacturing & Beyond

8:00-9:45 Standardization and Validation of Single Use Systems

Transition from R&D to Early Stage Process Development Sponsored by Sartorius Stedim Improving Process Robustness Innovative Strategies and Automation Advances

for Capacity Improvements

10:15-11:45 Supply Chain – Overcoming Scalability and Security Issues with Single Use Systems The Race from DNA to IND Raw Materials

Debottlenecking Operations & Improving Operational Efficiency

11:45-12:30 Technology Workshop Presentations12:30-1:40 Luncheon Presentations

1:40-3:15Can Single Use Support Adoption of

Continuous Processing? The Race from DNA to IND (continued) Innovation at the Interface of Late Stage PD and Commercial ManufacturingIntegrating with Monitoring Equipment

3:25-4:30 Keynote Presentations 4:30-6:30 Networking Reception & Grand Opening of the Poster & Exhibit Hall

Wednesday, March 1, 2017 • Main Conference Exhibit Hall & Poster Viewing Hours: 9:45 am to 6:30 pm




8:00-9:45Feasibility and Scalability of

Single Use Systems

Cell Line Development & Clone Selection Compressing Timelines for Process Characterization and Process Performance Qualifications

Equipment Cleaning and Change Over Strategies for Multi-Product Facilities

10:15-11:45 Cell Culture and Media Development Approaches to Optimize Efficiency, Quality and Productivity

Process Validation Strategies from Late Stage to Launch

Post Launch Supply Chain Continuity & Environmental Sustainability

12:05-12:35 Technology Workshop Presentations by GE Healthcare and Irvine Scientific12:35-1:40 Luncheon within the Poster & Exhibit Hall

1:40-3:15

Utilizing Single Use in Commercial Manufacturing & Hybrid Approaches

Process Development for Non-mAb and Non-Protein Products

Innovation in Bioprocess – Science Applied to Life Sponsored by 3M

Process Improvements, Optimization, and Post Launch Changes

4:00-5:30Utilizing High Throughput Development and

Process Modelling to Improve Predicting at Scale Performance

New Technologies in Bioprocess Development & Accelerating Bioprocess Development

Through Innovation Lifecycle Management of Mature Products

3M’s Young Scholar Award for Innovative Work in the Bioprocesses

5:15-6:30 BPI West Spring Party in the Poster & Exhibit Hall

Thursday, March 2, 2017 • Main Conference Exhibit Hall & Poster Viewing Hours: 9:35 am to 2:00 pm

Flexible Facilities Early Stage Process Development & Clinical Manufacturing

Late Stage Process Development & Commercial Launch Preparation Viral Safety

8:00-9:35Facility of the Future - What Technologies are Required?

What Flexibility is Required? Is it Scale Question or a Modality Question? Can it be Both? Use of New Technologies and Approaches in

Downstream Processing

The Technology Roadmap Viral Risk Mitigation in Upstream Processing

10:15-11:45 Closed Processing / Advantages & Disadvantages of Ballroom Approach

Ensuring Successful Process Scale Up, Transfer, Facility Fit, and Process Performance Qualifications New Technologies for Downstream Viral Clearance

11:50-12:30 Technology Workshop Presentation by GE Healthcare12:30-1:55 Luncheon in the Poster & Exhibit Hall

1:55-4:00 Design and Operational ConsiderationsPurification Process

Development for Non-mAbs

Next Generation Unit Operations, Continuous & Integrated Processes

Late Phase Viral Clearance RequirementsSponsored by AsahiKASEI


PRE-CONFERENCE SYMPOSIA • Monday, February 27, 2017

3.Filling the Bioprocessing Toolbox with Novel Tools

and Technologies 12:00 Registration & Coffee 1:00 Chairperson’s Opening Remarks

Upstream Processing 1:15 Advancing CHO Cell Factory Engineering

with CRISPR TechnologyHelene F. Kildegaard, Ph.D., Senior Researcher and Co-PI, Novo Nordisk Foundation Center for Biosustainability, University of Denmark, Denmark

1:45 Non-Cellular Based Platforms/In Silico SynthesisTrevor J. Hallam, Ph.D., Chief Scientific Officer, Research, Sutro Biopharma

2:15 Experiences Automating the Roche Cedex BioHT and HiRes with the Flownamics SegFlow On-line Sampling SystemKristin O’Neill, Associate Principal Scientist, Merck

2:45 Networking Refreshment BreakDownstream Processing

3:15 A Novel Chromatographic Technology: Enhancing Performance Utilizing a Modular Lattice Supported Resin Bed Marty Siwak, Director, Separ3tion Science Group, JSR Life Sciences

3:45 In-Line Diafiltration(ILDF): A Practical Solution for Continuous Buffer Exchange and Increased Plant VersatilityBriana Russo, MSc., Process Development Engineer II, Pre-Clinical Manufacturing and Process Development, Regeneron Pharmaceuticals, Inc.

4:15 Integrated High-Throughput Technologies for Rapid Process Development and Analytical SupportMagnus Schroeder, Ph.D., Director, Downstream Process Development, CMC Biologics, Inc.

4.Cell-Based Immunotherapies

– From Concept to Commercialization

Cell-based immunotherapies have the potential to transform current medical practice and offer an opportunity to effectively manage what were once considered untreatable diseases. Despite a large increase in basic science activity in the cell therapy arena, alongside a growing portfolio of cell therapy trials, the number of industry products available for widespread clinical use correlates poorly with such a magnitude of activity – with the number of cell based therapeutics in mainstream use remaining comparatively low. This symposium serves to incorporate key aspects of the commercialization process and examines how therapeutic candidates can be successfully translated from basic science into commercially viable products. The symposium will address fundamental translational barriers spanning the so-called “valley of death” and delineate sustainable and efficient mechanisms that can support the commercialization process. Topic coverage will include preclinical, clinical, manufacturing, intellectual property, regulation and market components.

Instructor:David A. Brindley, MEng, DPhil, FRI, FRSA, Chief Scientific Officer, Aegate; Managing Partner, IP Asset Ventures; Senior Research Fellow, Paediatrics, University of Oxford, United Kingdom

Keynote Presentation 4:50 Drivers in Innovation and How Biosimilars will Increase Price Pressures and Drive

Innovation and Intensification

Jens Vogel, Ph.D., President and CEO, Boehringer Ingelhiem Fremont, Inc.

5:30 Close of Pre-Conference Symposia

2.Biosimilars - From Early Stage Development to

CommercializationWhat are the Challenges for Biosimilars and Follow-On

Biologics During Early & Late Stage Development

• Reducing cost of goods • Cell culture process development • Similarity assessment and manufacturing challenges• Controlling/tailoring product quality attributes for

Biosimilars• Challenges and approaches in the development of a

biosimilar purification process

Challenges for Commercialization• Scale up challenges• Controlling/tailoring product quality attributes • Real-time glycosylation monitoring • Whole cell glyco engineering/Controlling

glycosylation patterns • Current regulatory landscape for biosimilar

commercialization

1.Continuous Processing

Early Stage Process Development• Challenges with scaling down process steps• Platform approaches• Considerations for characterization and validation for

continuous processes • What are the advantages of continuous at early

stage? • Right sizing the development program to meet your

goals • Process modeling for continuous processing

Late Stage Process Development• Going from early stage batch to late stage continuous

– What are the challenges?• Review of PAT that would need to be implemented to

support continuous processing• Review of overall automation and control strategy for

the continuous process• Validation of a continuous process in a GMP

environment • What is the definition of a batch? • How do you do viral clearance? Continuously or

single unit operation at a time?

Analytics for Continuous Processing• Real-time data analytics

PANEL DISCUSSION: Considerations Used to Choose Between Batch and Continuous • Modelling cost and benefits of continuous processing• Challenges in developing models for continuous

processing• Desired phenotype of cell line for continuous

processing

Sponsored by:9:30 am – 3:00 pm CHT™ Ceramic Hydroxyapatite Process Column Packing WorkshopBio-Rad invites you to visit the Process Chromatography Laboratory in Hercules, CA to learn best practices and guidelines for packing CHT Media at process scale. This workshop will include live demonstrations and training on CHT media transfer methodologies and column packing. Lunch will be served.All registrations are subject to approval, space is limited. A bus will depart from Hilton San Francisco Union Square at 9:30 am and return at approximately 3:00 pm.


MAIN CONFERENCE • Tuesday, February 28, 2017




7:00 Registration & Coffee8:00 Chairperson’s Opening Remarks Chairperson’s Opening Remarks Chairperson’s Opening Remarks Chairperson’s Opening Remarks

Standardization and Validation of Single Use Systems

Transition from R&D to Early Stage Process Development

Sponsored by Improving Process Robustness

(8:15) FEATURED PRESENTATION State of the Life Sciences IndustrySara Radcliffe, President, CLSA

8:15 Update on BPOG/BPSA Collaborations: Best Practices for Single-Use Change Notification and User Requirements Sabrina Restrepo, Ph.D., Associate Director, Sterile and Validation Center, Merck & Co.Jeff Carter, Ph.D., Strategic Projects Leader, Life Sciences, GE Healthcare

Developability Assessment of Therapeutic Antibodies – A Concept for Early Lead Selection & A Case Study (Upstream, Downstream, Formulation, and Analytics)Duc Nguyen, Ph.D., Lab Head, Integrated Biologics Profiling (IBP) Novartis Biologics Technical Department & Manufacturing (BTDM)

To Redevelop or Not; A CMO’s Perspective Matthew P. Zustiak, Ph.D., Head of Upstream Process Development, Process Development, Patheon Biologics Innovative Strategies and Automation

Advances for Capacity Improvements

8:45 Standardized Extractable/Leechable Testing Requirements Ekta Mahajan, M.S., Principal Engineer, Genentech, Inc.

Applying QbD Principles in Early Stage Process Development Facilitates the Scale-Up of Robust Processes Speaker: TBA

PCPV Strategies and Analytics Used for PCPV Studies Yun Tang, Associate Director, Genentech, Inc.

Automation and Data Integration in Biotherapeutic Production: Implementation of a Laboratory Execution System(LES) at Lonza Jessica Jean, Global QC Specialist, QC, Lonza Biologics

9:15 The Use of BPOG Generated Extractables Data for Toxicological Risk Assessment Sade Mokuolu, Ph.D., Group Product Compliance Manager, Product Compliance, Watson Marlow Fluid Technology Group, United Kingdom

Accelerated Biologics Development from Discovery to FIH and BeyondXiao-Ping Dai, Ph.D., Senior Director, Biologics Development and Manufacturing, Celgene Corporation

Design, Manufacturing and Implementation Considerations in Drug and Delivery Platform Development for Low Resource Setting Applications Stephen Gerrard, MEng, PH.D., Program Officer, Global Health, Bill and Melinda Gates Foundation

Enabling Flexibility Through Automation for a New Manufacturing Facility Ryan Hogan, MSc., Scientist I, Manufacturing Sciences & Technology, AstraZeneca

9:45 Networking Refreshment Break

Supply Chain – Overcoming Scalability and Security Issues with Single Use Systems

Sponsored by

The Race from DNA to IND Raw Materials Debottlenecking Operations & Improving Operational Efficiency

10:15 Bulk Freeze Challenges – Can SUT Really Address the Challenge for Full Scale?Adam S. Goldstein, M.S., Principle Scientist, Global Manufacturing Sciences, Genentech, Inc.

Accelerating Timeline to IND by Using Pool for Tox Strategy Wendy Hsu, MSc., Engineer II, Early Stage Cell Culture, Genentech, Inc.

A Synergistic Life Cycle Approach to Understand and Control Raw Material Variability through Collaborative Process Analytics Gunnar Malmquist, Ph.D., Staff Scientist, R&D, GE Healthcare, Sweden

Commercial Manufacturing & Beyond – Our Journey to Protect ‘white space’ Jennifer Martinez, MBA, Senior Manager, Manufacturing Initiatives, Genentech, Inc.Jeb Taylor, Associate Director, Downstream Manufacturing, Genentech, Inc.

10:45 Designing the Next Generation Single-Use Film: Utilizing Materials Science to Meet Performance Requirements and Security of Supply NeedsSusan E. Burke, Ph.D., Staff Scientist, Material Science Leader, Bioprocess R&D, GE Healthcare

Need for Speed: Platform Enablers and Enabling Platforms to Reduce Timelines in Early Phase Cell and Process DevelopmentBenjamin Sommer, Ph.D., Head, Early Phase Small-Scale USP Development, Biologics Technical Development & Manufacturing, Novartis Pharma AG, Switzerland

Managing Raw Material Variability Duncan Low, Ph.D., Scientific Executive Director, Amgen Inc.

Designing for Capability and Manufacturability: A Lifecycle ApproachGregory R. Naugle, MSc., Executive Director, Process Development, Amgen, Inc.

11:15 PANEL DISCUSSION How Do We Manage Change in the Single-Use World? Risk and Impact Moderator: Ekta Mahajan, M.S., Principal Engineer, Genentech, Inc. Panelists:Adam S. Goldstein, M.S., Principle Scientist, Global Manufacturing Sciences, Genentech, Inc. Duncan Low, Ph.D., Scientific Executive Director, Amgen Inc.

Site-Specific Glycosylation Analysis of Therapeutic Proteins by Pronase Digestion and Mass Spectrometry Zhikai Zhu, Ph.D., Ph.D., Senior Scientist, Analytical Development, Process Sciences, AbbVie

Extractables/Leechables Impact on Cell Culture

Overcoming Operational Challenges During Tech Transfer in a Multi-Product Facility by Utilizing Six Sigma ToolsPadmadhar Madupu, MS, Technical Manager, Manufacturing, Pfizer Inc.


MAIN CONFERENCE • Tuesday, February 28, 2017

Concurrent Technology Workshops11:50 Outsourcing Biosimilars Process Development

Cedric Bas, R&D Director, mAbxience

Luncheon Presentations12:30 New Single-Use Platforms for MAbs, ADCs and Vaccines

Reduce Costs and Increase Speed to Clinic & Speed To Market Speaker: TBA

TBA

1:40 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s Remarks

Single-Use Early Stage Process Development & Clinical ManufacturingLate Stage Process

Development & Commercial Launch

Preparation

Commercial Manufacturing

& Beyond

Can Single Use Support Adoption of Continuous Processing?

Sponsored by The Race from DNA to IND (continued)

Innovation at the Interface of Late Stage PD and Commercial Manufacturing

1:45 Topic TBDPall Life Sciences

Fast to IND: Decreasing Timelines from DNA to IND SubmissionDorothea Reilly, M.S., Senior Scientist, Early Stage Cell Culture, Genentech, Inc.

A Platform Approach for Commercialization of mAbs Abhinav Shukla, Ph.D., Senior Vice President, Development & Manufacturing, KBI Biopharma Inc.

2:15 Topic & Presenter TBD Speed to IND: Risks to Achieving Aggressive Breakthrough/Fast-track Product Timelines Susan Dana Jones, Ph.D., Vice President and Principal Consultant, BioProcess Technology Consultants

Topic & Presenter TBD

2:45 Integrating with Monitoring Equipment PANEL DISCUSSION: Accelerating to GLP MaterialTopics to be discussed include:• What are the benefits and risks of accelerate timeline to GLP material? How does it impact timeline to IND? • What are the major constraints and critical path items in development timelines to GLP and how these impact timeline

to clinic? • What are the different strategies and approaches that have been attempted in the industry to accelerate to GLP

material? Lessons learned and points to consider in adopting different approaches. • What are the Risk and Benefits of using material generated from non –clonal cell line /pools vs. clonal cell lines for

GLP studies? How is product quality comparability and pool instability addressed and managed?Moderator: Pranhitha Reddy, Ph.D., Consultant, Gene to BLA LLCPanelists:Susan Dana Jones, Ph.D., Vice President and Principal Consultant, BioProcess Technology Consultants

FEATURED PRESENTATION Unleashing the Power of Innovation to Tackle Biomanufacturing’s Greatest Challenges, Fuel Growth and Drive Value Creation Ran Zheng, Ph.D., Vice President, Development Supply Chain, Amgen, Inc.

Integrated PAT Tools for Upstream & Downstream Processes Anoushka Durve, MSc., Analytical Science, Analytical Science, Boehringer Ingelheim

3:15 Networking Refreshment Break

Keynote Presentations 3:55 Chairperson’s Remarks

4:00 Priorities in Global Healthcare and Burden of Disease: Are We Doing the Right Things in Biopharma and Vaccines? Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare, Sweden

430 Development & Manufacturing of Exosomes - A New Therapeutic Modality with Tremendous Potential Konstantin Konstantinov, Ph.D., Senior Vice President, Manufacturing & Process Sciences, Codiak Biosciences

4:30 Opening Night Reception in the Exhibit Hall


MAIN CONFERENCE • Wednesday, March 1, 2017




6:45 Registration & Coffee 7:15 Technology Workshop: (continental breakfast will be served)

Process Liquids and Buffer Handling: Solutions for Increased Efficiency David Jones, Senior Product Manager, Process Liquids and Buffers, GE Healthcare

8:00 Chairperson’s Opening Remarks Chairperson’s Opening Remarks Chairperson’s Opening Remarks Chairperson’s Opening Remarks8:05 FEATURED PRESENTATION

Innovations in Biomanufacturing with Single Use Technologies – Overcoming the Challenges Through CollaborationJeffrey Johnson, New Technology Lead and Director, Center for BioManufacturing Sciences, Merck & Co., Inc.

Cell Line Development & Clone Selection

Compressing Timelines for Process Characterization and Process Performance Qualifications

FEATURED PRESENTATION Transformations of a Large Scale Commercial Facility: From Reactive to Proactive to Preactive Thomas Seewoester, Ph.D., Executive Director and Plant Manager, Amgen Inc.

Next Generation of Automation for Cell Line Development at Light SpeedTrent Munro, Ph.D., Scientific Director, Amgen Inc.

Multiple Approaches to Process Characterization Studies Sigma Mostafa, Ph.D., Vice President, Process Development, KBI Biopharma

Equipment Cleaning and Change Over Strategies for Multi-Product FacilitiesFeasibility and Scalability of

Single Use Systems(8:30) Is There Only One Cell in the Well? David Shaw, Ph.D., Senior Scientist, Early Stage Cell Culture, Genentech, Inc.

(8:30) The Design, Qualification, and Application of Scale-Down Models for Protein Purification Process in BiopharmaceuticalsRichard Ding, Ph.D., Principal Scientist, Downstream Process Development, Patheon Biologics

8:35 Topic TBD Duncan Low, Ph.D., Scientific Executive Director, Amgen Inc.

Evaluating Protein Inactivation During Cleaning and Sterilization - Rational Approach for Setting Safety-Based Acceptance Limits for BiologicalsRizwan Sharnez, B. Tech., M.S., Ph.D., Scientific Director, Process Development, Amgen Inc.

(8:55) Doing More With Less: Higher Productivity in CHO Cells With Lower Selection PressureChristine DeMaria, Ph.D., Director, Cell Line Development, Sanofi

(8:55) Strategies for a Lean Process Characterization Program Ryan Hamilton, Ph.D., Principal Engineer, Late Stage Cell Culture, Pharma Technical Development, Genentech, Inc.9:05 Scale Up Vs Scale Out -

What Drives the Decision? Andrew Sinclair, MSc., FREng, President, Biopharm Services Ltd, United Kingdom

Development of a Synergistic Cleaning Method to Improve Protein A Resin Lifetime and Mitigate Bioburden ContaminationBharat V. Bhut, Associate Principal Scientist, Biologics Process Development & Commercialization, Merck Manufacturing Division, Merck & Co.

(9:20) Implementation of a High-Throughput Screening Platform to Accelerate Commercial Cell Line Production and Upstream Process DevelopmentJente Lu, Ph.D., Scientist II, Cell Culture Process Development, BioMarin Pharmaceutical Inc.

(9:20) Implementation of Various Technologies for Accelerated Development and Characterization of Biopharmaceuticals Torben P. Frandsen, MSc., Ph.D., Vice President, Process Development, CMC Biologics

9:35 Networking Refreshment Break in the Poster and Exhibit Hall

Feasibility and Scalability of Single Use Systems (continued)

Cell Culture and Media Development Approaches to Optimize Efficiency,

Quality and ProductivityProcess Validation & Continued

Process VerificationPost Launch Supply Chain Continuity

& Environmental Sustainability10:15 A Perfusion Bioreactor Platform Enabling

Fast, Cost-Effective Clinical Scale Biologics ProductionScott Waniger, Vice President, BioServices Division, Cell Culture Company

(10:05) Medium Development Approaches for a High Cell Density Fed Batch ProcessAmy Johnson, Ph.D., Senior Staff Engineer, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals Inc.

Process Validation - Internal Versus External Sourav Kundu, Ph.D., Senior Director, Global Biologics, Teva Pharmaceutical

Single Use Technology and Sustainability: Quantifying the Environmental Impact William P. Flanagan, Ph.D., Director, Ecoassessment Center of Excellence, Corporate, General Electric

(10:30) Development of a High-Seed Fed-Batch Cell Culture Process to Increase Volumetric ProductivityNing Liu, Ph.D., Associate Senior Consultant Engineer, Bioproduct Research & Development, Eli Lilly and Company

10:45 Feasibility of Sartorius’ Single Use Univessel® and Comparison with Applikon’s Glass Bioreactor for Monoclonal Antibody-Producing CHO Cell Cultures Adiba Zanghi, Ph.D., Senior Scientist III, BioProcess Development, Abbvie Biotherapeutics Inc.

Process Characterization – It’s Not a Science Project Michael Glacken, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.

Topic TBDRx 360 Representative

(10:55) Speeding Up Development of BispecificsAndy Racher, Ph.D., Associate Director, Future Technologies Group at Lonza Pharma & Biotech, United Kingdom

11:15 Scalability of a Single-Use Bioreactor Platform Based on Process Development for 25+ MoleculesNiket Bubna, MS, Senior Scientist, Process Development, KBI Biopharma

Continued Process Verification (CPV) Informatics Systems and Validation Carly Cox, Process Informatics Manager, Global Engineering, Pfizer

Topic TBD(11:20) Harvest Alternatives for Extremely High Cell Density Culture Juan Lagos, Senior Scientist, Upstream Process Development, Patheon Biologics


MAIN CONFERENCE • Wednesday, March 1, 2017

Concurrent Technology Workshops11:50 Understanding Sources of Variation in Chemically-Defined Media

and Feeds Through Raw Material Characterization Cory Card, Principal Scientist, Cell Culture, GE Healthcare

12:30 Networking Luncheon in the Poster and Exhibit Hall


Innovation in Bioprocess – Science Applied to Life

Sponsored by


1:40 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s Remarks Chairperson’s Remarks


Process Development for Non-mAb and Non-Protein Products

Sponsored by

New Technologies in Bioprocess Development & Accelerating

Bioprocess Development Through Innovation

Process Improvements, Optimization, and Post Launch Changes

1:45 Hybrid Single-Use/Fixed Clinical Manufacturing Facility Sourav Kundu, Ph.D., Senior Director, Global Biologics, Teva Pharmaceutical

Development of a THIOMAB™ Conjugation Process Utilizing Novel Linker ChemistryXin Xin Lin, Engineer II, Purification Development, Genentech, Inc.

Presentation by Merck Identification and Reduction of Variability in Culture Cell Specific Productivity Yuval Shimoni, Ph.D., MSc., Principal Engineer, Manufacturing Sciences, Bayer

2:15 Cell Culture in Stainless Steel and/or in Plastics – The Rentschler Decision ProcessPeter J. Rogge, Senior Director, Upstream, Process Technology and Manufacturing, Rentschler Biotechnologie GmbH, Germany

Hurdles and Opportunities for New, and Old, Vaccines David Robinson, Ph.D., Consultant, Robinson Vaccines and Biologics LLC

Presentation by RPI Novel Manufacturing ID Testing and Handling Technologies David Kolwyck, M.S., MBA, Director, Manufacturing Sciences, Biogen

2:45 Challenges in Forecasting the Demand for Biopharmaceuticals and the Value of Flexibility Thomas C. Ransohoff, Vice President and Principal Consultant, BioProcess Technology Consultants, Inc.

Moving Beyond Capture and Selecting Product Quality Attributes with Affinity PurificationWarren Kett, Ph.D., Chief Scientific Officer, Avitide

Presentation by BMS Multiproduct Resin Reuse (MRR) for Biopharmaceuticals - Application to Clinical and Commercial Manufacturing Rizwan Sharnez, B. Tech., M.S., Ph.D., Scientific Director, Process Development, Amgen Inc.



(continued)

Utilizing High Throughput Development and Process Modelling to Improve Predicting at Scale Performance

3M’s Young Scholar Award for Innovative Work in the Bioprocesses

Lifecycle Management of Mature Products

4:00 The Use of an End to End Disposable Manufacturing Train in the Production of GMP Clinical Immuno-Oncology Drug SubstanceBarry McCarthy, MSc., Director LM-API, Pharm Development & Manufacturing Sciences, Janssen R&D

Beyond Bind-and-Elute, Using High Throughput and Modeling to Develop Overload ChromatographyChris Williams, MSE, Senior Engineer, Purification Development, Genentech, Inc.

Eligibility: Scientist less than 35 years old that have applied new technologies in bioprocess development and/or have accelerated bioprocess development through innovation. 4:00 Young Scientist Presentation #1 from Amgen4:10 Young Scientist Presentation #2 from Genentech4:20 Young Scientist Presentation #3 from Regeneron4:30 Young Scientist Presentation #4 from GSK4:40 Young Scientist Presentation #5 from Gilead4:50 Young Scientist Presentation #6 from Bayer5:00 Presentation from 3M5:10 Announcement of Young Scientist Award Winners

Lifecycle Management of Analytical Control System – A Practical Application Case Study Paul Motchnik, Ph.D., Associate Director, Global Biologics, Quality Control, Genentech, Inc.

4:30 PANEL DISCUSSION What are the Gaps that Still Remain with Single Use Technologies?Moderator: Pete Latham, President and Managing Partner, Latham BioPharm Group Panelists: Jeffrey Johnson, New Technology Lead and Director, Center for BioManufacturing Sciences, Merck & Co., Inc.

Leveraging HTPD to Streamline Implementation of Non-platform Therapeutics to Minimize Impact to Development TimelinesJennifer Pollard, MSc., Senior Principal Scientist, Process Development and Engineering, Merck & Co.

Topic TBD Theresa Kitchener, Manager, Manufacturing Sciences and Technology, Genzyme

5:15 BPI West Spring Party


MAIN CONFERENCE • Thursday, March 2, 2017

Flexible Facilities Early Stage Process Development & Clinical Manufacturing

Late Stage Process Development & Commercial Launch Preparation Viral Safety

7:30 Registration & Coffee 8:00 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s Remarks Chairperson’s Remarks8:05 FEATURED PRESENTATION

Beyond Single Use and High Titer - More Efficient Facilities for the Next FrontierParrish M. Galliher, Chief Technology Officer, Upstream Bioprocessing, GE Healthcare

Use of New Technologies and Approaches in Downstream

Processing

FEATURED PRESENTATION Achieving High Throughput Manufacturing in a Multiproduct FacilityPaul Jorjorian, Senior Director, Operations, Patheon

FEATURED PRESENTATION Use of Confocal Microscopy to Study Virus Capture during Virus Filtration Andrew Zydney, Ph.D., Distinguished Professor, Chemical Engineering, The Penn State University

Facility of the Future - What Technologies are Required? What Flexibility is

Required? Is it Scale Question or a Modality Question? Can it be Both?

Mixed Mode Continuous Countercurrent Tangential Chromatography (CCTC) for a Model Monoclonal Antibody Purification Process David S. Kahn, Associate Engineering Advisor, API Process Engineering Center, Eli Lilly and Company

The Technology Roadmap Viral Risk Mitigation in Upstream Processing

8:35 Flexibility by DesignMorten Munk, Global Technology Partner, Global Best Practice, NNE Pharmaplan, Denmark

Improving Downstream Manufacturing Efficiency with Development Pre-Packed Chromatography Columns Michael J. Dittmer, Associate Scientist, BioProcess Engineering, MedImmune

A Technology Roadmapping Process to Transform the Biopharmaceutical Manufacturing Industry Stewart McNaull, Ph.D., Director, Development and Technical Services, Fujifilm Diosynth Biotechnologies

Topic TBDMilliporeSigma

9:05 Biomedical Advance Research and Development Authority’s Response to the Ebola and Zika Health Emergencies R. Thomas Warf, Director, Facilities and Engineering, BARDA

Development Strategies for Reducing Host Cell Proteins in Recombinant Proteins Bradley D. Johnson, Ph.D., Head of Purification Development, Process Development, Patheon Biologics

PANEL DISCUSSION Progress Toward Shared Vision to Align Industry’s Innovation EffortsModerator and Panelists TBD

Viral Risk Mitigation in Upstream Processing Shengjiang “Shawn” Liu, Ph.D., Chief Scientist, Pathogen Safety, Bayer Pharmaceuticals LLC


Closed Processing / Advantages & Disadvantages of Ballroom Approach

Use of New Technologies and Approaches in Downstream

Processing (continued)

Ensuring Successful Process Scale Up, Transfer, Facility Fit, and Process

Performance QualificationsNew Technologies for Downstream

Viral Clearance

10:15 Data-Driven and Risk-Based Approaches for Area Classification Selection for Biopharmaceutical Processes Scott T. Probst, Ph.D., Unit Head, Process Technology Development, Biologics, Engineering and Technology, Bayer

Challenges of Host Cell Proteins and their Removal in Process DevelopmentTroii Hall, M.S., Associate Consultant Chemist, Bioprocess Research & Development, Eli Lilly and Company

Technology and Facility-Fit Approaches to Late-Stage Biologics Development and Manufacturing for a Diverse Portfolio of Internal and Contract Manufacturing Products Nuno Fontes, Ph.D., Executive Director, Process Science, Boehringer Ingelheim

Characterizing and Enhancing Virus Removal with Protein A Min Zhang, MSc., Technical Development Scientist, Purification Development, Genentech, Inc.

10:45 Topic TBDBob Munday, PMP, General Manager, Site Head, CMC Biologics

Improved Downstream Operation Through Formulation Innovation Nicholas J. Darton, Ph.D., Technical Lead, Formulation, Arecor Ltd., United Kingdom

Highlights and Challenges of a MAb Tech Transfer from a DS Manufacturing Production Site to Another Donna Quicho, Principal Research Associate, Purification Development, PTD, Genentech, Inc.

An Integrated Approach to Viral Safety: Risk Assessment, Mitigation and Process UnderstandingHouman Dehghani, Ph.D., Director, Process Development, Amgen Inc.

Viral Safety for Continuous ProcessingSponsored by

11:15 PANEL DISCUSSION What does Ballroom Truly Mean?Moderator and Panelists TBD

Single-Use Primary Capture Technology Enabling New Process Development Opportunities to Improve Process Robustness for mAb ManufactureOliver Hardick, Ph.D., CEO, Puridify Ltd., United Kingdom

Things to be Required for Successful Process Lock, Tech Transfer and Process Performance QualificationYongjick Kim, Ph.D., Independent Consultant

Topic TBDPall Life Sciences

PRESENT A POSTER TO SHOWCASE YOUR COMPANY’S LATEST RESEARCHAny registered attendee may present a poster for display inside the Exhibit Hall at BPIWest. Presenting a poster is a great way to share your company’s latest research with the global bioprocessing industry. Submit your poster abstract online by January 27, 2017.Poster Fee: $125 for Industry, Complimentary for Academic/Government


MAIN CONFERENCE • Thursday, March 2, 2017

Concurrent Technology Workshops11:50 Bioburden Challenge and Improve Productivity with Extended

Disposable Downstream ToolsJosefin Bolik, Product Manager, GE Healthcare

12:30 Networking Luncheon in the Poster and Exhibit Hall

Flexible Facilities Early Stage Process Development & Clinical ManufacturingLate Stage Process

Development & Commercial Launch

Preparation

Commercial Manufacturing

& Beyond

1:55 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s Remarks Chairperson’s Remarks

Design and Operational Considerations

Purification Process Development for Non-mAbs

Next Generation Unit Operations, Continuous & Integrated Processes

Late Phase Viral Clearance Requirements

Sponsored by

2:00 Process Design for an All Single-Use Manufacturing Facility: Scaling Low to High Titer Processes to Fit Standard mAb Equipment PlatformsStewart McNaull, Ph.D., Director, Development and Technical Services, Fujifilm Diosynth Biotechnologies

Purification of Human Hemoglobin and Drug Conjugation for Liver TargetingJ. Gord Adamson, Ph.D., Scientific Director, Drug Development, Therapure Biomanufacturing, a division of Therapure Biopharma Inc.

Topic TBDUwe Gottschalk, Ph.D., Chief Scientific Officer, Lonza, Switzerland

Late Stage Viral Clearance Studies (BLA): Study Design and Experiences Made Horst Ruppach, Ph.D., Director, Viral Clearance and Virology, Biologics Testing Solutions, Charles River Inc.

2:30 A New Stainless Steel Manufacturing Facility: Flexibility without Complexity Joseph Neal, MSc., MBA, Scientist I, Manufacturing Sciences & Technology, AstraZeneca

Modular DSP Approaches for CoRe-Designing Purification Processes for Oligonucleotides; What’s Achievable?Robert Gronke, Ph.D., Senior Principal Scientist,Technical Development, Biogen

Continuous Manufacturing ApplicationsJonathan Souquet, Ph.D., Head of Biotech Process Sciences Technology & Innovation, Biopharma, Global Manufacturing & Supply, Merck Serono SA, Switzerland

Designing Robust Virus Filtration Processes to Maximize Operational Flexibility While Achieving Small Virus Removal Daniel Strauss, Ph.D, Senior Scientist, Asahi Kasei Bioprocess America

3:00 Flexible Facilities and Flexible Aseptic FillingJim Nadlonek, Pharmaceutical Operations Specialist, Bausch + Stroebel Machine Company

Modular DSP Approaches for Complex Non-mAB MoleculesStefan R. Schmidt, Ph.D., MBA, Vice President, Process Science and Production, Rentschler Biotechnologie GmbH, Germany

Topic TBDKumar Dhanasekharan, Ph.D., Senior Director, Biologics Process and Analytical Development, Amicus Therapeutics

Viral Clearance: Log Reduction Values and Trends Within the IndustryIjeoma Ikechukwu, Senior Scientist, Downstream Process Development, Patheon

3:30 Close of Conference


MEET THE PEOPLE BEHIND THE PRODUCTS & GET THE ANSWERS YOU NEED

TO LEARN MORE ABOUT BPI WEST AND BEGIN BUILDING YOUR CUSTOM SPONSORSHIP PACKAGE, CONTACT:A-L: JENNIFER WICKETT • 857.504.6694 • [email protected] | M-Z: AIMEE CROKE • 857.504.6697 • [email protected]

3MAdvantaPure/New AgeAminoAcids.comANGUS Life SciencesApplikon BiotechnologyAragen BioscienceAsahi Kasei BioprocessAvantorAvitideAxcellerate Pharma, LLCBD BioscienceBeckman Coulter Life SciencesBend Research, a division of CapsugelBerkeley Lights, Inc.Bio-Rad LaboratoriesBioTech LogicBoehringer IngelheimBroadley James CorpBrukerCatalentCell Culture CompanyCharles RiverCharter MedicalCMC BiologicsCPCCustom BiogenicsCytovanceDistek, Inc.Emergent BiosolutionsEndress + HauserEnsingerEntegrisEppendorfEssential PharmaceuticalsEurofins Lancaster LabsFarrar Scientific CorpFinesse SolutionsFlownamicsFrieslandCampina IngredientsFujifilm Diosynth BiotechnologiesGEGyros Protein TechnologiesHamiltonIDBS

ILC DoverInfors USAIrvine ScientificJNCJSR Life SciencesKaiser Optical SystemsKanekaKBI BiopharmaKuhner ShakerKyowa Hakko USA, Inc.LevitronixLEWAMalvern InstrumentsMeissner Filtration ProductsMillipore SigmaNOVA BiomedicalO3 Sterilization Systems created by BurkertOptek Danulat, Inc.Pall Life SciencesParker Domnick Hunter Process FiltrationPatheonPendoTechPneumatic Scale AngelusPrometicPuroliteQosinaRentschler Biotechnologie GmbHRepligenRocheSaint-GobainSartorius Stedim BiotechSpectrumLabs.comTherapure Biopharma Inc.Thermo Fisher ScientificTosoh BioscienceVacciXcellVR AnalyticalVWR Single-Use SolutionsWatson-Marlow Fluid Technology GroupWinpact Scientific YSI

EXHIBITOR LIST (as of January 4, 2017)SPONSORS (as of January 4, 2017)

Event Partners

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Exhibit Hall & Poster Viewing HoursTuesday, February 28th – 3:15 to 6:30 pm

Wednesday, March 1st – 9:45 am to 6:30 pmThursday, March 2nd – 9:35 am to 2:00 pm

the only phase-based event to break down silos for … · 2017-01-10 · the only phase-based event...

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