Keynote Presentations

Innovating mAb Production to Support the Immunotherapy Revolution David J. Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co. Inc. Innovative Process Development Strategies to Drive the Rapid Clinical Introduction of Emerging Biologics Spencer Fisk, Global Head, Biologics Process R&D, Novartis Pharma AG, Switzerland Novel Approach to Developing and Producing Human Experimental Vaccines for HIV Michael Anthony (Tony) Moody, M.D., Chief Medical Officer, Associate Professor of Pediatrics, Duke Human Amgen’s Next-Generation Biomanufacturing Facility Kimball Hall, Vice President Manufacturing, Amgen Singapore Manufacturing Pte. Ltd. What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production? Konstantin Kostantinov, Ph.D., Vice President, Technology Development, Genzyme – What is the Future of Continuous Processing

Pre-conference Symposia

Cell Therapy Bioprocessing

Allogeneic Cell Therapy Manufacturing Process Design: A Rational Approach Harvey Brandwein, Vice President, Business Development, Pall Corporation Development of a Lentiviral Vector Production Process by Transient Transfection in Serum-Free Suspension Culture for CAR-T Immunotherapy Qi Wei, Ph.D., Senior Scientist, Cell and Gene Therapy, Novartis Developing Novel Methods for Maintenance of Pluripotency in ESC During Expansion and Improvement of Directed Differentiation of OPCs Eric Whitely, Ph.D., Director of Development, Asterias Biotherapeutics

ADC Development and Production

ADCs: Leveraging Shared Learnings to Enable Next Generation Success Alan C. Rigby, Ph.D., Vice President, ADC Biology, Eli Lilly and Company Overcoming Challenges and Enhancing Production of Antibodies for Site-Specific Antibody-Drug Conjugates Marie Zhu, Ph.D., Director of Process Sciences & Manufacturing, Agensys Inc. Tuning the Efficacy of Antibody Drug Conjugates Via Site-Selective Conjugation Alan Wahl, Ph.D., Vice President, Research and Discovery, Ambrx, Inc.

Innovation In Process and Product Development Technologies for Biopharmaceutical Development

New Technologies for Platform Based Development of Antibody Processes Kumar Dhanasekharan, Ph.D., Director, Process Development, Cook Pharmica LLC Development of Platform Host Cell Protein Enrichment Strategies for Use in Impurity Spike Challenge Studies Ryan G. Soderquist, Ph.D., Senior Scientist, Purification Process Development, Amgen Accelerating Characterization Using Definitive Screening Design Dogan Ornek, Ph.D., Principal Scientist and Group Leader, Fermentation and Cell Culture Development, Fujifilm Diosynth Biotechnologies U.S.A., Inc.

Future of Biomedicine and Biomanufacturing

Presentations will be delivered from Industry Experts focusing on:

• Future Manufacturing Features and R&D Portfolio Discussion
• Biomarkers and Future Analytic/Process Control Strategies
• Facility of the Future
• Continuous Processing Strategies
• Closed Processing, Ballroom Concepts, and Single-Use in Future Manufacturing
• Future Molecules(Including Bispecifics and Designed Molecules) and Cell Therapies Replacing Antibodi

Cell Culture

Application of CRISPR/Cas9 Technology to Improve Cell Line Development and Production Jae Seong Lee, Postdoc, Ph.D., The Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark Raising the Bar: Advanced Analytics in Upstream Bioprocess Development Christopher Yu, Ph.D., Senior Scientist, Protein Analytical Chemistry, Genentech, A Member of the Roche Group Mitigating Scale up and Process Challenges for a High Cell Density CHO Perfusion Process in Single-Use Bioreactors Hang Yuan, Ph.D., Associate Director, BioProcess Development, Shire

Recovery and Purification

Overcoming Downstream Bottlenecks in Downstream Processing Siddharth Parimal, Ph.D., Senior Engineer I, Biogen Elastin-like Polyeptide Fusions for Purification and Delivery of Biologics Ashutosh Chilkoti, Ph.D., Professor and Chair, Department of Biomedical Engineering, Duke University High Throughput Methods to Streamline Process Development and Improve Process Understanding John Welsh, Associate Principal Scientist, Process Development and Engineering, Merck & Co.

Drug Product Manufacturing & Fill-Finish Processing

Streamlining Biological Drug Development to Ensure Manufacturing Continuum from Drug Substance to Drug Product: Phase-Specific Strategies to Improve Success Suketu Desai, Ph.D., Vice President, Biologics Development, Drug Substance and Drug Product R&D, Allergan, Inc. Developing a Strategy for Container Closure Integrity – Value of USP Guidance Donald Singer, Quality Manager, Microbiology, R&D, GlaxoSmithKline Combination Product Development – Drug Product Development and Fill-finish Challenges and Strategies Sujit Basu, Ph.D., Head, Drug and Combination Products, Shire

Manufacturing Strategy

A Holistic Approach to Developing a Robust Drug Product Manufacturing Process that Ensures Consistent Product Quality Attributes Ganapathy Gopalrathnam, Senior Research Scientist, Bioproduct Pharma Design/Formulations, Eli Lilly & Company Therapeutic Protein Production On-Demand Govind Rao, Ph.D., Professor and Director, Center for Advanced Sensor Technology, University of Maryland, Baltimore County A.S.A.P (Automated Seamless Antibodies Purification): Toward a Fully-disposable and Continuous Process Benoit Mothes, Scientific and Innovation DSP Head, Bioprocess Science and Technologies Department, Sanofi, France Jerome Pezzini, Ph.D., DSP Process Scientist, Bioprocess Science & Technologies, Sanofi, France

Analytical, Formulation and Quality

Innovation Development within a Strategic Supplier Program Dave Kolwyck, Director, Manufacturing Sciences, Raw Material Global Process Owner, Biogen Condensed Playbook for Continued Process Verification (CPV) Marcus Boyer, Ph.D., Associate Director of Process Life-cycle Management, Bristol-Myers Squibb Building a Process Improvement Strategy for a Legacy Biologics Process Which Enables Implementation of a Next Generation Process Amanda Ashcraft, Manager, Process Engineering Development, Manufacturing Technical Support, Genzyme

Early Stage Biologics and Companies

De-risking Timeline Acceleration and Improving Product Quality: A Case Study of Integrating Lead Selection and Early Development Activities Susan Dana Jones, Ph.D., Vice President and Principal Consultant, BioProcess Technology Consultants Going Small to Understand the Big: Scale-Down Model Qualification and Use in Process Characterization Klaus Kaiser, Ph.D., Head of Downstream Processing and Analytics, Global Biological Development, Bayer Pharma AG, Germany

Cell Culture Dish Sponsor Activities:

Beckman Coulter – Booth 200

BD Biosciences – Booth 707

Talks:

Thursday October 29th, 8:05 Comparative Assessment of Bioanalyzer Technologies Through Analysis of Cell Culture Media Components Stacy Holdread, Staff Scientist, BD Biosciences , BD Advanced Bioprocessing

Biovest International – Booth 225

Event:

Wednesday October 28th, 7:00 – 10:00 PM Bioprocess Networking Event Hosted by mAbVault Complimentary Food and Drinks Dillon’s Bar and Restaurant 955 Boylson St. (1 block from Hynes Convention Center) *By RSVP only – Space Limited – RSVP at: http://mabvault.eventbrite.com

Featured Products:

• mAbVault: a novel fixed-price protein contract manufacturing service

Corning – Booth 902

GE Healthcare Life Sciences – Booth 511

Talks:

Wednesday October 28th, 2:45 Points to consider for Commercial Continuous Bioprocessing Parrish Galliher, Chief Technology Officer, GE Healthcare Life Sciences Thursday October 29th, 3:45 BPSA’s 2015 Single-Use Quality Test Matrices Guide Jeff Carter, Ph.D., Director R&D, GE Healthcare

Technology Workshops:

Tuesday October 27th, 11:50 Optimized and Consistent Protein Glycosylation in Biosimilar Production William G. Whitford, Senior Manager Cell Culture, GE Healthcare Wednesday October 28th, 12:05 Single-Use Fermentation: Understanding Process Economy and Process Performance Kenneth Clapp, Senior Global Product Manager, Bioreactors, GE Healthcare Insights into Recent Developments in Protein A Chromatography Henrik R. Ihre, Director Custom Design Chromatography Media, GE Healthcare Life Sciences

Tour and Technology Workshop:

GE Single-Use Biomanufacturing Tour and Technology Workshop by bus – Marlborough, MA Thursday October 29th, 2:00 PM Friday October 30th, 8:00 AM Make the most of your visit to Boston by visiting GE Healthcare Life Sciences Single-Use Biomanufacturing facility in Marlborough, MA. GE will host a private tour and technology workshop demonstrating and discussing flexible and efficient GMP facilities (limited availability). See the factory … Meet the experts … Sign up today! Contact Jennifer Wickett: (508) 614-1672 • jwickett@ibcusa.com

New Product Announcements:

• ActiPro media platform
• Cytodex Gamma : cytodex 1 and cytodex 3 gamma compatible, and delivered sterile and ready to use. Launch Q1 2016
• New singke use Xcellerex Mixer 2500L Xduo and XDM. Launch Q1 2016.
• New SIngle Use fermentor 500L, Xcellerex XDR MO 500, launch Q2 2016.

EMD Millipore – Booth 317

Luncheon Presentation:

Tuesday October 27th, 12:20 The Future Journey from Molecule to Commercial Production Sue Walker, Provantage End-to-End Solutions, Merck Millipore

Talk:

Thursday October 29th, 3:30 Extractables Test Methods: Progress Towards a Standard Janmeet Anant, Ph.D., Product Manager, EMD Millipore

Essential Pharmaceuticals – Booth 1029

Talk: Thursday October 29th, 7:30 AM Increasing Protein Production with Novel Cell Ess Supplement without Affecting Metabolic Profile Enhancing protein production is a common bioproduction goal. At a concentration of 1% Cell Ess supplement resulted in a 37% increase in productivity. Used as a feed, it resulted in a 25% increase in yield and extension of peak protein production. Our results suggest that an increase in protein production may not require a change in the metabolic state of the cells. Adam Elhofy, Ph.D., CSO, Research & Development, Essential Pharmaceuticals

Poster Presentation as Selected by BioProcess International:

Thursday October 29th 11:30 AM at the BPI exhibit hall stage Novel Lipid Based Supplement Increases Protein Yield in Single Use Bioreactor Adam Elhofy, Ph.D., CSO, Research & Development, Essential Pharmaceuticals

Poster:

BPI Exposition Hall Use of Novel Cell-Ess Supplement Increases mAb titer and Productivity from CHO Cells Grown in Serum Free systems Tuesday, October 27, 2015: 4:45pm – 6:30pm Wednesday, October 28, 2015: 9:45am – 7:00pm Thursday, October 29, 2015: 9:45am – 2:00pm

Featured Products:

• Cell-Ess cell culture supplement increases protein yield in previously optimized cell-media systems without altering glycosylation or metabolite profile. Chemically defined, animal component free.

Finesse – Booth 517

Booth Presentations:

Finesse Solutions – The Future of Biomanufacturing

Featured Products:

• Smart MES
• SmartFactory
• Full Range of bench top offering for lab scale and process development:
  • G3 Lab Universal Controller
  • SmartGlass re-usable bioreactor line of all sizes 1-15L
  • SmartRocker rocking single-use bioreactor

PALL Life Sciences – Booth 309

Symposium:

Monday October 26th 8:30-5:00 Cell Therapy Bioprocessing

Talks:

Recovery and Purification Tuesday October 27th 8:00 Implementation of Continuous Processing Marc Bisschops, Ph.D., Principal Scientist, Continous Processing, Pall Life Sciences Tuesday October 27th 8:55 Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing Mark Schofield, Ph.D., Principal R&D Engineer, Applications R&D, Pall Life Sciences Manufacturing Strategy Thursday October 29th 11:30 Beyond Single-Use: Implementing New Manufacturing Strategies for Increased Process Efficiency Annelies Onraedt, Ph.D., Global Marketing Director, Cell Culture Technologies, Pall Life Sciences, Germany Practical Experiences from Single-Use Technology Implementation Lisa Bradbury, Ph.D., Director, Pall Life Sciences

Technology Workshops:

Thursday October 29th 12:05 Significant Technology Advances Enable Integrated Continuous Bioprocessing Michael Egholm, Ph.D., V.P. and General Manager, Pall Biopharmaceuticals, Pall Biopharmaceuticals Division, Pall Corporation Room TBD; followed by an optional booth tour

Featured Products:

• Acoustic Wave Seperation (AWS) Technology from FloDesign Sonics
• Cadence™ InLine Concentrator
• BioSMB System
• FlowStar LGR
• Octet K2
• Hyperion Stax™
• PadReactor Mini
• SoloHill® Microcarriers

For more information about Pall’s activities at BPI, please see the following: http://www.pall.com/main/about-us/event-details.page?id=20150611055620 http://www.pall.com/html/biopharm/bpi/index.html http://www.pall.com/html/biopharm/bpi/registration.html

Thermo Scientific – Booth 403

Posters:

Targeting desired N-linked glycosylation profiles through the use of glycosylation enhancing feeds and process development It has been well established that glycosylation is a key product quality attribute for many biotherapeutic proteins expressed in CHO cells. N-linked glycans may display macro- and micro-heterogeneity; the degree of this variation can depend on several factors, including cell line, media/feeds, and process. As a consequence, it has often been challenging to achieve and maintain preferred glycosylation profiles from cell culture development through bioreactor scale-up. In order to address these challenges, we have developed a new feed technology in conjunction with a unique fed-batch process that together have been shown not only to maximize protein titers but also to allow for precise targeting of desired glycan profiles. In recent studies with an IgG-expressing CHO DG44 cell line, when utilizing standard concentrated feeds in combination with concentrated glycosylation enhancing feeds we demonstrated a progressive series of adjustments of G0F glycan proportion from 45% to 90% while still maintaining growth and productivity. This approach avoids inherent limitations associated with supplement-based methods where it can be challenging to determine the appropriate amount required to achieve a specific profile.

Implementation and Scale-Up Results When Using a 50L Single Use Bioreactor and Alternating Tangential Flow Filtration (ATF) Device for Continuous Processing Improvements in single-use systems have allowed implementing high-density cultures in standard work flows. The current study shows integration of the Thermo Fisher Hyperforma S.U.B. and the Repligen ATF6 perfusion system to achieve high-density cultures. Scalability of the S.U.B. versus a glass bench-scale reactor is shown. The S.U.B. was able to support high-density cultures (>40E06 cells/mL) without modification to standard single-use components and maintained proper operating parameters similar to those at bench-scale. The data show that the 50L S.U.B. and ATF6 can be used in a high-density seed train or as a small-scale production vessel producing 100L/day of product.

Single Use Fermentor – Process Optimization and Scale-up of Microbial Cultures Recent innovations in single use technologies (SUT) have allowed traditional microbial fermentation processes to quickly capture the established benefits that have been proven over the past decade with animal cell culture processes when using disposable processing equipment. The Thermo Fisher Scientific Hyperforma Single Use Fermentor (SUF) is designed to deliver equivalent performance to stainless steel SIP/CIP reactors for research and pilot scale microbial bioproduction at 30L and 300L liquid working volume. To demonstrate feasibility, several studies were performed in 2014 for the purpose of determining if key process demand aspects of modern recombinant microbial strains like E. Coli and P. Pastoris could be met in the SUF. To this end, prior work did confirm the feasibility of meeting two critical benchmarks – high oxygen uptake demands (kLa of >600 per hour) and being able to monitor and control foam generation inside the disposable bag. Still there have been further questions from academia and industry as to if these new process systems have the ability to support broader and perhaps more aggressive applications. For example, being able to operate at an elevated process temperatures, rapid temperature shifts (heat shock induction), near precision exponential nutrient feed delivery, and cascade type oxygen sparge mass transfer control integrations are critical topics that merit further investigation. In this poster, new data we be presented that demonstrates the benefits of utilizing gain scheduling methods to enhance standard type PID control loops outcomes for the SUF when culturing E. Coli (results in more robust feed, pH, DO, and temperature regulation). Furthermore, new experimental results will present the benefits and technical challenges of configuring a system to deliver enhanced recombinant plasmid production via induction using rapid temperature shifts. This work serves to highlight that with proper guidance and relevant experience, SUT end users may successfully compensate for the constraints limits of both disposable bags and compact temperature control units that are commonly employed when using modern single use products.

Implementation and Scale-Up Results When Using a 50L Single Use Bioreactor and Alternating Tangential Flow Filtration (ATF) Device for Continous Processing Improvements in single-use systems have allowed implementing high-density cultures in standard work flows. The current study shows integration of the Thermo Fisher Hyperforma S.U.B. and the Repligen ATF6 perfusion system to achieve high-density cultures. Scalability of the S.U.B. versus a glass bench-scale reactor is shown. The S.U.B. was able to support high-density cultures (>40E06 cells/mL) without modification to standard single-use components and maintained proper operating parameters similar to those at bench-scale. The data show that the 50L S.U.B. and ATF6 can be used in a high-density seed train or as a small-scale production vessel producing 100L/day of product.

Featured Products:

Stop by the booth to learn more about 2 new products and bulk liquid capabilities:

• Gibco™ GlycanTune™ A+/B+/C+ Total Feed—a complete feed that offers the simplest and most efficient way to dial in a consistent glycan profile for consistent protein quality
• Gibco™ Water for Injection (WFI)—sterile, cell culture–grade, WFI-quality water now available in 20 L and 200 L sizes
• Bulk liquid capabilities—ready-to-use cell culture media, buffers, supplements, and other process liquids packaged in catalog standard and customized BioProcess Containers (BPCs)

Roche Custom Biotech – Booth 217

Talks:

Tuesday October 27th 8:05 Critical Quality Attribute (CQA) Assessment – From Theory to Practice! Marco Thomann, Ph.D., Group Leader, Development Analytics, Roche Diagnostics GmbH, Germany Thursday, October 29, 8:05 High-Throughput Approaches to Process Development Stacy Holdread, Staff Scientist, BD Biosciences, BD Advanced Bioprocessing

Luncheon Technology Workshop:

Tuesday, October 27, 12:20 p.m. Technology Workshop: Integrate, acquire, and centralize in-process data from Roche Cedex analyzers Clint Pepper, Ph.D., Bend Research; Ali Yeyinmen, Product Manager, MUSA

Products and capabilities that will be showcased:

• Cedex Bio and Bio HT Analyzers
• Cedex HiRes Analyzer
• mRNA portfolio and customization capabilities
• Pharma QC portfolio
• Glycoengineering product portfolio
• Proteases

Trick or Treat! Tuesday October 27th 4:45 Halloween Reception and Exposition Hall Grand Opening The opening night reception sponsored by Roche will feature a Halloween theme complete with a fun and festive ambiance. Come and enjoy Halloween-inspired food, drinks, decorations and games while networking with exhibitors, poster presenters and other attendees in the exposition hall.