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BioProcess International Conference & Exposition

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Conference: October 26-29, 2015 * Exposition:  October 27-29, 2015 * John B Hynes Veterans Memorial Convention Center, Boston, MA


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

Conference: October 26-29, 2015 · Exhibition: October 17-19, 2015 · John B Hynes Veterans Memorial Convention Center · Boston, MA

Manufacturing Strategy

Manufacturing Strategy

Manufacturing Strategy

Biomanufacturing experts share strategies to maximize efficiencies and cost savings across your manufacturing network through implementation of disruptive technologies, operational excellence and new facility concepts. Learn how to develop your manufacturing infrastructure so you can remain flexible to the production needs of a diverse pipeline of novel biologic molecules in a multiproduct environment.

Topics include:

  • Operational efficiency, facility optimization, process economics and manufacturing portfolio planning
  • Manufacturing technologies and case studies to increase efficiency in clinical or commercial production
  • Single-use technology implementation case studies (clinical and commercial)
  • Biomanufacturing of emerging modalities and complex molecules
  • Continuous processing and continuous biomanufacturing

Tuesday, October 27, 2015

Registration and Coffee

Chairperson's Remarks
Richard Reineke, Director, Upstream Manufacturing, Amgen, Inc.

Strategies to Ensure Manufacturing Efficiency and Quality

A Holistic Approach to Developing a Robust Drug Product Manufacturing Process that Ensures Consistent Product Quality Attributes
Ensuring consistent product quality attributes for a given manufacturing process begins with an understanding of the clinical design. The clinical design enables a quality target product profile (patient centered), which forms the basis for developing a robust manufacturing process, encompassing drug substance, formulation excipients, package components, formulation composition, manufacturing process, in-process testing, product specifications, and supply chain.
Ganapathy Gopalrathnam, Senior Research Scientist, Bioproduct Pharma Design/Formulations, Eli Lilly & Company

A Successful Lean Manufacturing System in a Biologics Manufacturing Plant
Can biologics DS supply be reliable and cost-reduced? Do operators connect daily performance to quality and cost? Are new product introductions too slow? A successful lean manufacturing system at Amgen Rhode Island has decreased cost, reduced errors and increased speed. New daily practices have reduced scrap, increased reliability and improved yields. Well-trained operators, purposeful presence and a safety-first culture have decreased non-conformances and improved new product introductions.
Richard Reineke, Director, Upstream Manufacturing, Amgen, Inc.

A Life Cycle Approach to Managing Risk throughout the Design, Qualification, and Operation of Manufacturing Systems
Risk management is most effective when used prospectively during product development and process design, when design and control systems are easily modified to reduce risk and improve product quality. Building quality into drug product manufacturing processes up front is better than testing these products for defects later. The use of risk management to design, qualify, and operate systems used in manufacturing processes is beneficial.
Ghada Haddad, Director, Engineering, Sterile & Validation CoE, Merck & Co.

Networking Refreshment Break

New Concepts in Facility Design and Biotherapeutic Production

Therapeutic Protein Production On-Demand
In a paradigm shift from the conventional large scale therapeutic protein manufacture at a site distant from the end user, our team has been developing a compact, agile platform designed to produce therapeutic proteins at the point-of-care. In this presentation, we will describe our progress towards making a briefcase size device that will serve as the factory of the future and enable biologics production on-demand at the point-of-care. Our core technology uses a novel CHO cell extract for in vitro expression of virtually any protein and couples it with a simple, single step intein-based purification system that has the potential of producing a therapeutic ready for delivery to the patient. This entire device and process are being robustly validated by analytics and regulatory teams. Case studies based on the production of Streptokinase and Erythopoietin will be demonstrated.
Govind Rao, Ph.D., Professor and Director, Center for Advanced Sensor Technology, University of Maryland, Baltimore County

Automation in Biotherapeutic Production: Implementation of Laboratory Execution Systems at Lonza
Jessica Jean, Associate Director, Quality Control, Lonza Biologics, Inc.

Process Simulation and Facility Modeling: Identification of Increased Throughput Enabling Projects in a Complex Multiproduct Manufacturing Environment
Biogen's portfolio of drug substance process/facility models is used to analyze multi-product manufacturing scenarios. Models are leveraged to identify potential capital projects that can directly increase facility throughput and quantify relative impact of "competing" projects (i.e. reductions in product changeover time vs. reductions in batch to batch turnaround times).
Suzanne Stuhler, Senior Process Engineer, Operations Technology & Innovation, Biogen

Concurrent Technology Workshops

Continuous Processing at 2000L Single-Use Bioreactor Scale
Christel Fenge, Vice President of Marketing for Fermentation, Sartorius Stedim North America

Case Study
Optimized and Consistent Protein Glycosylation in Biosimilar Production
In the development of biosimilars, the biopharmaceutical industry is challenged with driving product quality toward equivalence with the innovative biotherapeutic. The consistent glycoform profile of biosimilars produced through large-scale cell culture is an important criterion that can dictate biological efficacy and ultimately regulatory approval. In addition, there is an increased interest in enhancing cell densities and product yields. This presentation will review advancements in glycosylation control in mammalian cell culture obtained through optimizing basal media, feeds, and process parameters. Case studies discussing recent optimization work utilizing the HyClone™ Metabolic Pathway Design process to, not only, improve product qualities, such as increased afucosylation or tri- and tetra-sialylated glycans, but also to increase cell density and enhance protein productivity, will be presented.
William G. Whitford, Sr. Manager-Cell Culture, GE Healthcare

CQA Impurity Monitoring for Integrated Bioprocessing
This contribution proposes a novel approach using direct measurements of Critical Quality Attributes (CQA). We propose a CQA analyzer, which is based on a HPLC principle combined monolithic columns, which is used horizontally along the entire process, from upstream to downstream processing. Together with advanced multivariate data analysis algorithms, the chromatogram can be used as a fingerprinting method, allowing to track host cell impurities CQAs in a timely controlled way. Hence we present a PAT tool as per original definition.
Dr. Christoph Herwig, Professor of Biochemical Engineering, Vienna University of Technology, Austria

Rapid Production of Recombinant Proteins and Stable Cell Lines at Different Scales
James Brady, Ph.D., Vice President, Technical Applications & Customer Service, MaxCyte, Inc.

Mechanical Stress in Standard and Single-Use Pumps Using Cell- and Particle-Based Stress Analysis
The development of shear sensitive pumps is necessary to avoid cell or even product damage in the biopharmaceutical industry. In this study, the mechanical stress acting on cells, proteins and an emulsion were determined for commonly used pumps (e.g. peristaltic and diaphragm pumps) and compared to an alternative pump technology - the magnetically levitated centrifugal-pump (MagLev pump). For these investigations, the MagLev pumps caused lower mechanical stress on cells, proteins and emulsion drops compared to their counterparts.
Ina Dittler, MSc. Research Assistant, School of Life Sciences and Facility Management, Zurich University of Applied Sciences

Luncheon Presentations

The Future Journey from Molecule to Commercial Production
Perhaps the not so distance future of biodevelopment and production will have significantly reduced clinical development timelines, flexibility when utilizing single use technologies such as direct scalability, closed upstream processing, and continuous downstream options, as well as the ability to implement local production facilities on a global basis. The past decade has been one of rapid growth and change for single use technologies and they are establishing their identity within biopharma. And technology in general, the principle driver of globalization, has made the world larger in terms of access to emerging markets. This presentation will discuss the potential future state for processing using single use technologies as well as accelerated biodevelopment and deployment of these production facilities on a global basis.
Sue Walker, Provantage End-to-End Solutions, Merck Millipore

Integrate, Acquire, and Centralize In-Process Data from Roche Cedex Analyzers: Overview of Auto-Sampling Technologies from Flownamics and Bend Research and Data Management Solutions from Musa
Paul Strand, Application Engineer, Flownamics
Ali Yeyinmen, Product Manager, MUSA
Clint Pepper Ph.D., Bend Research

Chairperson's Remarks
Seongkyu Yoon, Ph.D., Assistant Professor and Director, Massachusetts Biomanufacturing Center, University of Massachusetts Lowell

Continuous Processing and Building in Manufacturability

A.S.A.P (Automated Seamless Antibodies Purification): Toward a Fully-disposable and Continuous Process
A new purification process has been developed in Bioprocesses Vitry, enabling to run 3 chromatography steps in continuous mode with no holding time nor open phase. A cell culture bulk containing the Monoclonal Antibody can be now fully processed through this continuous process to obtain a pure Monoclonal Antibody batch without human intervention, decreasing also resin and buffer costs. New updates were added to enable the use of membrane absorbers and become a fully disposable 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

Continuous Biomanufacturing: The Future of Antibody Production
We present a rapid continuous biomanufacturing platform process that combines a perfusion mammalian cell culture with a synchronized purification of the antibodies produced without the use of intermediate holding tanks or surge bags. The bioreactor is connected to a cell retention device and optimized to 1 (vvd) or less while immediate recovery and purification of the antibody is obtained using a single Protein A column bysynchronizing the rate of perfusion with the antibody capture. This approach offers a cost effective and flexible platform process for the manufacture of both stable and unstable therapeutic agents.
Seongkyu Yoon, Ph.D., Assistant Professor and Director, Massachusetts Biomanufacturing Center, University of Massachusetts Lowell

Manufacturability Considerations during the Development of a Phase III Cell Culture Process for the Production of an IgG4 Antibody
This presentation describes our systematic approach of building manufacturability into a Phase III cell culture process for the production of an IgG4 antibody using a cholesterol dependent NS0 cell line. In particularly, we will discuss a novel approach that was developed to control half antibody impurity, a critical quality attribute for this molecule, as well as progress made to address facility fit, improve productivity and reduce process complexity.
Marcella Yu, Ph.D., Staff Scientist II, Commercial Cell Culture Development, Genzyme, a Sanofi Company

Short Break to Move to Keynote Session

Keynote Presentations

Chairperson's Remarks

David J. Pollard, Ph.D. Innovating mAb Production to Support the Immunotherapy Revolution
A new paradigm in cancer therapy is emerging with the recent success of the antibody mediated, immune tumor killing response for melanoma. Evaluations have expanded to include a range of tumor types. In addition new alternatives and combinations are aimed at improving patient non responsiveness to PD-1. These foundational efforts of emerging cancer treatment need to be supported by agile antibody supply solutions that meet the capacity demands, while improving global access and lowering costs. Technology solutions have been implemented to speed process development and shorten the critical time to first in human clinical studies. Innovative approaches towards the 'process of the future' will be shown that support flexible multi product lower cost manufacturing. Continuous processing enabled by single use provides an integrated solution and the implementation challenges will be discussed.
David J. Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co. Inc.

Spencer Fisk Innovative Process Development Strategies to Drive the Rapid Clinical Introduction of Emerging Biologics
The movement of a large portfolio, consisting of a broad spectrum of biological molecule-modalities, requires seamless integration from the research bench to the clinic. Deep alignment and partnership between the Research and the Process/Analytics functions allows for rapid and systematic product candidate screening, eliminating the most problematic candidates. Combining state-of-the-art cell lines with a regimented application of robust high-throughput process and analytical development packages enables record speeds to the first patient with minimal resources.
Spencer Fisk, Global Head, Biologics Process R&D, Novartis Pharma AG, Switzerland

Michael Anthony (Tony) Moody, M.D. 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

Trick or Treat! 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.

Wednesday, October 28, 2015

Registration and Coffee

Technology Workshop with Light Continental Breakfast

Simplify and Intensify: Solutions for Cell Culture Process Intensification
Transformative cell culture technologies will be reviewed. The award winning ATF cell separation device enables process intensification and continuous processing, allowing for smaller bioreactors and smaller facilities in more locations. Media plays a key role in perfusion, the leading application for ATF, where addition of LONG®R3 IGF-I cell culture supplement boosts productivity significantly because it is 200 times more potent than insulin.
Millie A. Ullah, Ph.D., Associate Director, Product Management & Marketing, Repligen

Chairperson's Remarks

Keynote Presentations

Kimball Hall Amgen's Next-Generation Biomanufacturing Facility
Described here is the establishment of a biomanufacturing platform for the production of biologic medicines. Competitive product portfolios that can respond quickly to changes in market dynamics have necessitated optimization of production strategies. The "Next-Generation Biomanufacturing" platform allows for fast and flexible drug operations for synthesis of drug substance in a reconfigurable manufacturing system. Key enabling technologies include modular construction, single-use bioreactors, disposable plastic containers, continuous purification processing and real-time quality analysis. Amgen's Next-Generation Biomanufacturing changes the way we will manufacture in the 21st Century.
Kimball Hall, Vice President Manufacturing, Amgen Singapore Manufacturing Pte. Ltd.

Konstantin Konstantinov, Ph.D. What is the Future of Continuous Processing - What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme

Networking Refreshment Break in Exposition Hall Sponsored by:

Chairperson's Remarks
Dave Kolwyck, Director, Manufacturing Sciences, Raw Material Global Process Owner, Biogen

Strategic Supplier Programs and Leveraging Data Science

Innovation Development within a Strategic Supplier Program
The biopharmaceutical industry is developing increasingly stringent demands on the quality and consistency of the raw materials used in their manufacturing. To manage this complexity, many large pharmaceutical organizations are creating strategic supplier relationship programs to focus their development activities. This presentation will discuss strategies to manage a strategic supplier innovation pipeline that preserves the freedom to operate for both organizations and creates valuable solutions which can be broadly disseminated across the industry.
Dave Kolwyck, Director, Manufacturing Sciences, Raw Material Global Process Owner, Biogen

Solving the Genealogy Puzzle in Biologics Manufacturing
Data is being generated at all steps of biologics manufacturing from raw material suppliers through finished goods - but splits and joins in the process genealogy add tremendous complexity, which needs to be overcome in order to leverage all the data available. How can Data Science can help?
Gabe Josset, Senior Associate Scientist, Process Informatics, Biogen

Concurrent Technology Workshops

Case Study
Using Process and Activity to Drive Clone Selection
During a manufacturing cell line development project in stable CHO-K1 cells, a significantly reduced specific activity of target protein was observed when compared to a reference standard. This case study highlights how the lack of activity was identified and how the development of an optimized cell culture process enabled identification of high productivity clones.
Oren E. Beske, Ph.D., COO, Aragen Bioscience, Inc

Case Study
Single-Use Fermentation: Understanding Process Economy and Process Performance
The entry of single-use bioprocessing and the benefits that come with disposables have generated interest in the microbial community. This talk will present results from a process economy comparison of fermentation scenarios based on stainless steel and single-use equipment. Additionally, data will be shown from a wet-work study of an E.coli domain antibody production using stainless steel and disposable equipment.
Kenneth Clapp, Senior Global Product Manager, Bioreactors, GE Healthcare

An Insight into Recent Developments in Protein A Chromatography
Protein A-based chromatography is the primary method used to purify MAbs. There has been a significant development of protein A chromatography media (resin), giving both higher capacity and improved stability to meet the changing requirements of the industry. More improvements are to come. We will provide some insights into the future plans of GE Healthcare's Life Sciences business for protein A media and our thoughts on what will be needed for the next generation of products.
Henrik R. Ihre, Ph.D., Director Custom Design Media, GE Healthcare Life Sciences

Case StudyNew Data
Comparison of Methods and Materials for Single Use Bag Extractable Testing
This study highlights the relationship between two extractable test methods and the materials of construction of single use bag systems. The data show that the BioPhorum Operations Group (BPOG) protocol may not be sufficient as a single method for detecting extractables from single use bag systems, and that use of advanced materials like fluoropolymers allows more robust extractable detection methods.
Mike W. Johnson, Global Bioprocess Applications Manager for Life Sciences, Entegris, Inc

Case StudyNew Data
Introducing Amsphere A3: The Relationships and Considerations of Bead and Pore Structure, Surface Chemistries, and Ligand Design on Affinity Resin Performance
Industry needs, patent expirations of ligand design and market dynamics have accelerated the development and availability of many protein affinity resins. Technology providers must consider a range of design parameters such as resin backbone, bead size, pore size, surface chemistry modification, ligand construct and how they relate to performance criteria such as DBC, life time, caustic stability, and column packing among others. JSR's approach to designing Amsphere A3™ affinity resin will be discussed. The balance between resin design and resin performance will be illustrated through a case study.
Marty Siwak, Director, Separation Science Group, JSR Life Sciences
Zhuo Liu, Ph.D., Scientist, KBI Biopharma, Inc

Networking Luncheon in the Exposition Hall

Chairperson's Remarks
Tony White, Director, BioPhorum Operations Group (BPOG), United Kingdom

Continued Process Verification Strategies for Biologics

Condensed Playbook for Continued Process Verification (CPV)
Following the well-received publication of the BioPhorum Operation Group's (BPOG) CPV Case Study, the BPOG CPV team has created a 'playbook' or step-by-step guide to the implementation of CPV in table form. The guide aligns with the FDA's product lifecycle model and refers to a flow diagram. The aim is to make implementing CPV an activity that is accessible to everyone in the Biopharmaceutical Operations environment. This presentation will describe the playbook, and how to access and use it.
Marcus Boyer, Ph.D., Associate Director of Process Life-cycle Management, Bristol-Myers Squibb

Continued Process Verification (CPV) Informatics Systems and Validation
Fundamentally, the purpose of informatics system validation is to ensure a sufficient level of data integrity. In the case of Continued Process Verification (CPV), validation is complicated by the need to pull data from a number of source systems. The CPV Informatics system is essentially one that enacts data gathering processes and it is essential that the governance models for source systems are understood when the CPV system is set up. Validating efficiently, through risk assessment and justified approaches is essential, given the potentially massive informatics testing requirements for activities like CPV. Useful approaches will be highlighted in this presentation. It needs to be recognized that a CPV Informatics system will be subjected to changes after it has been released for use, and means of managing change will be part of this presentation.
Carly Cox, Senior Process Engineer, Pfizer

Implementing Continued Process Verification (CPV) for Legacy Products
In 2014, the BioPhorum Operations Group published the CPV Case Study, detailing how CPV plans can be created, with a focus on new products. Subsequently, the BPOG CPV team has considered the case of legacy products and this presentation covers their findings. It will include: the gathering and use of existing manufacturing data, the discovery of previous trends and management across multiple sites amongst other topics.
Bert Frohlich, Ph.D., Director, Process Controls and Quality by Design, Manufacturing Sciences & Technology, Shire

Networking Refreshment Break in the Exposition Hall Sponsored by:

Manufacturing Strategies for Legacy Products

Building a Process Improvement Strategy for a Legacy Biologics Process Which Enables Implementation of a Next Generation Process
Balancing the more pressing needs of a current process with the more strategic needs of a future generation is a daunting task, it can be especially difficult when improving a legacy process. Technical agendas can easily be too narrow, failing to enable necessary design space knowledge or performance enhancements that can be a bridge to the next generation. This is a case study of a plan that attempts to balance the needs of both.
Amanda Ashcraft, Manager, Process Engineering Development, Manufacturing Technical Support, Genzyme

Raw Material Control and Change Notification

Raw Material Control: A CMO Perspective on an Industrial Challenge
Based on regulatory guidances and advanced quality risk management practices, the biopharmaceutical industry is greatly focused on enhancing process robustness to ensure product quality. Development of an effective raw material characterization strategy is vital to achieving this objective. Through definition and examples, the approach currently being developed by Lonza Biologics for minimizing raw material variability for improvement of large-scale upstream operations will be discussed.
Seshu Tummala, Ph.D., Principal Scientist, Research and Technology, Lonza Biologics, Inc.

Importing Best Practice into Raw Material Change Notification
The way raw material change notifications are communicated in the biopharmaceutical industry often causes anguish and significant extra work for both suppliers and end users. Often, changes take too long to assess and there is a growing consensus that greater clarity and guidance would be beneficial on both the type of changes requiring advanced notice and the information needed for impact and risk assessment. A group of BPOG member companies are working together and with suppliers to develop such guidance. As part of this study they have reviewed the change notification solutions used in the aerospace, automotive and semi-conductor industries with the intention of importing best practice. This presentation will outline the team's work and their plans on this common challenge for us all.
Derek Hubley, Global Pharma QC Lead, Lonza

Casino Night Networking Reception in the Exposition Hall
Feeling lucky? Wednesday night's Networking Reception in the Exposition Hall will feature a Casino Night theme where attendees can try their luck at classic casino games like Blackjack, the Big Six Wheel, and Poker. Co-Sponsored by: and

Thursday, October 29, 2015


Bioprocess "Problem-Solving" Discussion Topics and Moderators

These moderated discussions on a variety of bioprocess topics will allow you to share strategies and brainstorm solutions in an informal, small group setting.
  • QbD for Analytical Methods: Sharing Experiences and Approaches
    Kazumi Kobayashi, Ph.D., Senior Principal Scientist, Technical Development, Biogen
  • Particulate Defects - Critical versus Minor
    Kevin Kerls, Inspection MSAT, Hillsboro Technical Operations, Genentech, Inc. - A Member of the Roche Group
  • Opportunities and Challenges of High Concentration Biologics
    Mark Moody, Ph.D., Chief Scientific Advisor, ReForm Biologics
  • Developability and Development: Improving the Outcome
    Valentyn Antochshuk, Ph.D., Principal Scientist, Group Leader, Formulation Design and Process Compatibility, Merck & Co.
  • Container Closure Integrity Testing and Technology
    Kevin M. Maloney, Ph.D., Principal Scientist, Technical Development, Biogen
  • Raw Materials Management in Biologics Production
    Dave Kolwyck, Director, Manufacturing Sciences, Raw Material Global, Process Owner, Biogen
If you are interested in proposing or moderating a discussion topic in this breakfast session, please email at Michael Keenan mkeenan@ibcusa.com.

Technology Workshop

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 than an increase in protein production may not require a change in the metabolic state of the cells.
Adam Elhofy, Ph.D., CSO, Essential Pharmaceuticals

Chairperson's Remarks
Lisa Bradbury, Ph.D., Director, Pall Corporation

Closed System Manufacturing

Case Study
ADC Production: Integration of the Conjugation Step in a Standard Protein Plant Using Closed Systems
ADC manufacturing in most cases uses 2 separate facilities for production, a protein plant with its typical segregation and a special toxin conjugation facility to produce the ADC drug substance. This talk will describe a set-up to do the toxin conjugation within the footprint of a downstream suite of a standard protein plant. The prerequisites to achieve that such as closed systems operation, using disposables as well as isolator technology for the conjugation part will be described in detail.
Berthold Boedeker, Ph.D., Chief Scientist, Global Biologics, Biotech Development, Bayer Pharma AG, Germany

Closed Processing and Sanitizing Temporary Openings
Closed processing in controlled, non-classified spaces mitigates risks associated with contaminants in the manufacturing environment whilst improving quality. Significant benefits can be gained in simplified facility designs and low levels of environmental control. However, advances in closed processing technology have not completely eliminated the need to temporarily open systems and it is impractical to use typical procedures for closure. To address this issue, the Biophorum Operations Group (BPOG) have collaborated with the Biotechnology Training and Education Centre (BTEC) to establish whether liquid sanitization can be used to effectively close a temporary opening in an otherwise closed system. A series of tests have been undertaken, using equipment that closely models real processing conditions. This presentation will report on these tests.
Kavita Ramalingam Iyer, Ph.D., Senior Specialist, Global Regulatory Affairs, Vaccine-CMC, Merck Sharp & Dohme Corp.

Innovative Manufacturing Solutions for Emerging (BRIC) Markets with Flexible Single Use Facilities
This presentation will discuss: 1) Developing and implementing flexible solutions for biologics manufacturing within emerging markets 2) Considering strengths and limitations of the market location during the planning process to ensure a successful facility 3) Developing and implementing innovative designs that support staged growth based on existing and evolving market demands 4) Utilizing technologies that decrease operational risk during the startup and operational phases of the facility.
Bob Munday, General Manager, Site Head, CMC Biologics, Inc.

Networking Refreshment Break in the Exposition Hall Sponsored by:

Practical Experiences from Single-use Technology Implementation

Design of a Clinical Manufacturing Facility Strategically Aligning Single-use and Fixed Equipment
The presentation will describe the design of a biologics clinical manufacturing facility that integrates single-use and stainless steel equipment strategically to take advantage of the strengths of both. Single-use bioreactors provide several advantages. Among them are: (1) Less capital and validation investments, (2) Flexibility, and (3) Quicker turnaround between batches. Single-use mixing systems provide similar advantages in terms of the initial capital layout and turnaround times. The facility will integrate single-use bioreactor and mixing systems with conventional stainless steel centrifuge and chromatography skids to take advantage of the latest technological advancements. The presentation will also describe the design philosophy for the facility incorporating optimum process, material and personnel flow as well as area classifications meeting the latest compliance requirements.
Sourav Kundu, Ph.D., Director, Biopharmaceutical Development, Teva Biopharmaceutical, USA

Considerations for Technology Transfer from Single-use to Stainless
Single-use manufacturing has been increasingly implemented in the recent years in the biotech industry for early phase clinical production. As programs advance, larger volume production is needed and traditional stainless technology is used. We will review considerations for technology transfer from single-use to stainless technology.
Anna Pisania, Ph.D., Staff Engineer, Acceleron

Beyond Single-Use: Implementing New Manufacturing Strategies for Increased Process Efficiency
In the surge of single-use manufacturing, too often the strategy for single-use technology adoption was based on technology equivalence of disposable to stainless steel. But what if single-use technologies bring something new to the process, something not possible before? An overview of some recent innovative single-use technologies illustrates the need to completely rethink the process to fully realize the technical and cost benefits of SUT.
Annelies Onraedt, Ph.D., Global Marketing Director, Cell Culture Technologies, Pall Life Sciences, Germany

Technology Workshop

Delivering process and cost efficiencies for early clinical and biosimilars production with ProcessReady Columns
Time and cost pressure are significant for biosimilar producers or in early clinical phase production. The selection of highly productive, cost-effective resins for DSP is critical. The addition of ready-to-use formats to such a campaign can enhance process intensification and drive greater cost efficiencies. This workshop will present a platform process with ProcessReady™ columns from Purolite, pre-packed with Praesto™ affinity and ion-exchange resins.
Chris Major, MSc., Director of Agarose and Bioprocessing, Life Sciences, Purolite

Breakthrough Technologies for Establishing Biosimilar Target Product Profile Quality Attributes
Molly McGlaughlin, VP Business Development, EirGenix

Pall Biopharmaceuticals' Leader Details Significant Technology Advances Enabling Integrated Continuous BioProcessing
There is a lot of talk about Continuous Bioprocessing, but how does the desire for a continuous bioprocess get turned into reality? Pall Life Sciences is committed to building a working GMP end-to-end continuous bioprocess. The building blocks are in place, now hear how they are to be assembled into an integrated process.
Note: The presentation will be followed by a curated tour of the technologies at the Pall booth
Michael Egholm, Ph.D., V.P. and General Manager, Pall Biopharmaceuticals, Pall Biopharmaceutucals Division, Pall Corporation

Technology Workshops
Have Your Presentation Included Here! Contact Jennifer Wickett (companies A-L) at jwickett@ibcusa.com or Kristen Schott (companies M-Z) at kschott@ibcusa.com for details

Networking Luncheon and Last Chance for Exposition Hall Viewing

Introduction of Groups, Members and Status of Collaborations
Tony White, Director, BioPhorum Operations Group (BPOG)
Kevin Ott, Executive Director, Bio-Process Systems Alliance (BPSA)

Single-Use Technologies and Applications:
A Coordinated View from Industry Consortia

Change Notification Allied Efforts
David Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co., Inc.
Eric Isberg, Director, Life Sciences, Entegris

User Requirements: A User Perspective
Christopher Shields, Director, Global Product Validation Services, Saint-Gobain Life Science

Networking Refreshment Break

Single-Use Technologies and Applications:
A Coordinated View from Industry Consortia

Extractables Test Methods: Progress Towards a Standard
Janmeet Anant, Ph.D., Product Manager, EMD Millipore

BPSA's 2015 Single-Use Quality Test Matrices Guide
Jeff Carter, Ph.D., Strategic Projects Leader, GE Healthcare

NEW! Town Hall Forum DiscussionSingle-Use Standardization: Progress in Improved Alignment of Guidelines
Moderator: James Dean Vogel, Founder and Director, The BioProcess Institute
BPOG Perspective: Tony White, Director, BioPhorum Operations Group
BPSA Perspective: James Dean Vogel, Founder and Director, The BioProcess Institute
PDA Perspective: Robert Repetto, Senior Director, External Affairs, Pfizer
ASTM Perspective: Robert Steininger II, ASTM SubCommittee Chairman, Biotechnology and Consultant, BioPE, LLC
ASME/BPE Perspective: Jay Ankers, Director of Technology, M+W Group

Close of Conference