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Single-Use Applications for Biopharmaceutical Manufacturing

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Innovation and Adoption of Single-Use Technology for Upstream, Downstream and Beyond

June 09-10, 2014 · Boston Park Plaza Hotel · Boston, MA

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  • Japanese
  • Taiwanese
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  • Korean

Agenda

Agenda

Monday, June 9, 2014

7:00
Registration and Coffee

7:55
Chairman's Opening Remarks
Fletcher Malcom, MBA, Associate Director, Product Management, Repligen Corp.

Keynote Presentation

8:00
Dr. Ying Gao Challenges of Implementing Disposables for Commercial Manufacturing
Adopting disposable single-use techniques is an increasing trend in biopharmaceutical manufacturing. However there are challenges in implementing disposables in a commercial manufacturing process. Case studies will be discussed in this presentation, with the implementation of a single-use system for improving a legacy commercial process. These include questions to address for process redevelopment or replacing obsolete single-use materials. Evaluation of extractable and leachable of the single-use system will also be discussed. Cost analysis has also been conducted to evaluate the process economic of single-use system and to support decisions in process improvement and manufacturing strategies.
Ying Gao, Ph.D., Technical Support Specialist, Process Analytical & Development Group, Development &Production, Public Health England, United Kingdom

Single-Use Considerations for Cell Culture Applications

8:30
Innovative Raw Material Management and Product Design Strategy for Enhanced Quality, Assurance of Supply, Validation & Change Control of Single-Use Systems
The growing adoption of Single-Use technologies in critical process steps of cGMP production presents new challenges. This lecture introduces a new supply chain strategy that involves partnerships with polymers and film suppliers to enhance assurance of supply, change control of resin materials and films for higher quality and transparency. Finally, the presenter describes the latest advances towards new generations of films and bag integrity testing.
Jean-Marc Cappia, VP Marketing & Product Management, Sartorius Stedim Biotech, France

9:00
Case Study
Single-Use Systems in a Perfusion (Continuous) Cell Culture Process: Technical and Logistical Considerations
Perfusion cell culture processes require the management of large volumes of process fluids on an ongoing basis for the length of a campaign. At the same time, the process must remain functionally closed for the duration of the campaign during supply line changeovers. Single-use storage systems play a key role in achieving these goals. This presentation explores the key technical and logistical reasons for single-use systems in a cell culture perfusion process.
Russell Wong, Ph.D., Principal Engineer, Bayer Health Care

9:30
New DataCase Study
Cell Therapy Bioprocess Economics and Optimization: Single-Use Cell-Expansion and Volume Reduction Technologies
An increasing number of cell therapies are entering Phase 3 clinical trials and commercialization. In contrast to the biopharmaceutical industry, the use of single-use technologies in cell therapy is a necessity. The development of a decisional tool to identify optimal technologies for varying production scales of cell therapies is presented. The tool integrates bioprocess economics with optimization to assess the competitiveness of single-use cell expansion (e.g. cell culture flasks or single-use bioreactors) and volume reduction technologies (e.g. tangential flow filtration or single-use centrifugation technologies). Process limitations and cost implications of these technologies are also explored.
Sally Hassan, Ph.D., Post-Doctoral Research Associate, Department of Biochemical Engineering, University College London, UK

10:00
Networking Refreshment Break in Poster and Exhibit Hall

10:40
Chairman's Opening Remarks
Chris Shields, MBA, Manager, Advanced Concept Engineering, Single Use Systems, Saint-Gobain Life Science

Single-Use Considerations for Cell Culture Applications (Continued)

10:45
Case Study
Identifying and Solving a Cell Growth Inhibition Issue Observed in Single-Use Shake Flasks
A common single-use system is the disposable polycarbonate shake flask. These sterile shake flasks are simple to use and available in a variety of sizes, creating ease for inoculum expansion activities. This presentation describes the experimental approach and data identifying leachables/extractables as the cause of an observed cell growth inhibition in large single-use shake flasks. The factors that led to the inconsistent nature of this observed growth inhibition are identified. The experiments highlight differences between vendor, flask size, clone, cell host, seeding density, batch duration, and media/media components. Information on resolving the issue will also be provided.
Olga Smiliotopoulos, M.S., Scientist, Culture Process Development, Bioprocess R&D, BioTherapeutics Pharmaceutical Sciences, WRD, Pfizer Inc.

11:15
New DataCase Study
Production of Cell Culture-Based Influenza A Virus in Single-Use Hollow Fiber Bioreactors
Single-use hollow fiber bioreactors (sHFBRs, Biovest International, USA) were seeded with either adherent or suspension MDCK cells, and infected with influenza A virus. High virus titers were obtained 48 to 96 hours, post- infection and virus yields were comparable and in some cases higher than those observed with conventional production platforms. These results demonstrate that sHFBRs may be an alternative choice for some commercial production of influenza virus.
J. David Gangemi, Ph.D., Professor Emeritus, Clemson University; and President and Chief Science officer, ViraCell Advanced Products, LLC

Concurrent Technology Workshops

11:45
Validation of Single Use Systems for Biopharmaceutical Fluid Transfer and Storage
An integrated approach to single use system validation includes; raw material selection, product design, component and system testing, quality certification and risk management. This presentation will highlight the current best practices for extractable, particulate and endotoxin testing of disposable fluid transfer and storage products and will highlight several case studies that utilized an integrated approach to single use system validation.
Chris Shields, MBA, Manager, Advanced Concept Engineering, Single Use Systems, Saint-Gobain Life Science

For more information on Technology Workshop presentations, please contact Kristen Schott at 508-614-1239 or kschott@ibcusa.com

12:15
Networking Luncheon in Poster and Exhibit Hall

1:25
Chairman's Opening Remarks
Chairman TBA

Single-Use Considerations for Cell Culture Applications (Continued)

1:30
New DataCase Study
Single-Use Mixing systems in Large-scale Live-viral Vaccine Upstream Processes
The technology transfer and downscaling of the ACAM2000® smallpox vaccine upstream manufacturing process from our manufacturing partner, Baxter, to the SP Biologics Facility in Canton, MA, has provided opportunities for innovation and modernization within the existing product license. The incorporation of single-use mixing systems at three stages of the aseptic closed-system process will be described. Vero cell viability, sterility, and mixing to homogeneity were assessed at each stage to establish validatable process parameters.
Daniel C. Vellom, Ph.D., Senior Director, Global Technology Innovation, Sanofi Pasteur Biologics

Process Development and Manufacturing Strategies and Considerations

2:00
Ensuring Single-Use System Reliability
A successful bioprocess must not leak fluid or permit uncontrolled ingress during storage and operation. Although traditional integrity testing techniques are well developed, translating these methods to single-use systems (SUS) is challenging. This presentation will review a risk assessment approach that leads to an appropriate level of system integrity qualification. Applicable test methods for SUS, and when to apply them, will also be discussed. Finally, best practices will be recommended for suppliers and end users to deploy during SUS design and qualification to increase system integrity assurance.
Mark A. Petrich, Ph.D., Associate Director, Component Engineering, Merck & Co.

2:30
Implementation of Disposable Container-Closures in Biotechnology Manufacturing Process
Implementation of product contact disposable container-closures for the long-term storage and stability of biological drug substance and drug product is a very challenging field with continuously increasing requirements. These requirements are not limited to internal manufacturing processes, but also include quality concerns from U.S. regulatory agencies. With increasing need for globalization of biotechnology manufacturing facilities and redundant production capabilities across the world, disposable container-closures now need to meet global manufacturing, regulatory, as well as cold-chain requirements for worldwide distribution and logistics. This talk will present some of the challenges faced in developing sustainable solutions to meet these requirements and successes along the way.
Amol Thote, Ph.D., Operations Manager, Bayer Health Care

3:00
Case Study
Adopting a Fully Single-Use Process to Improve Speed to Clinic - A Leachables Case Study
Little, if any, data has been published where leachables are evaluated under actual process conditions through a complete single-use clinical scale process train. We have addressed this by completing a pilot scale 100L "mock" mAb production and purification where the cells, and hence MAb protein, are absent but where the bioreactor was run for the normal duration with cell culture media and feeds, and the DSP train utilized all the standard process devices, buffers, conditions and procedures. Data will be presented on the leachables profile throughout the entire production process and, where relevant, a comparison made to the extractables data and risk assessment.
Ross W. Acucena, Regulatory Consultant, Provantage Services, EMD Millipore

3:30
Networking Refreshment Break in Poster and Exhibit Hall

4:15
Best Practices in Qualification of Single‐Use Systems in Bioprocesses
Single‐use systems (SUS) have been increasingly used in biopharmaceutical manufacturing processes in the past two decades. As the future of biomanufacturing, single‐use technologies have brought in many advantages in both upstream and downstream operations. However, this relatively new concept is still evolving and novel development is happening continually. Concurrently, there is no specific regulatory guidance on SUS. All these present challenges to qualifying SUS. It remains perplexing to many end users and suppliers as to how to effectively perform qualification of SUS. This presentation will discuss the best practices in SUS qualification.
Weibing Ding, Ph.D., Principal Scientist, Materials Science, Amgen Inc.

Interactive Panel Discussion

4:45
The Next Single-Use Frontier: Trends, Challenges and Opportunities
Moderator: Jessica Frantz, Field Marketing Manager, Aseptic Transfer System, Fluid Management Technologies, Sartorius-Stedim Biotech
Panelists:
Mark A. Petrich, Ph.D., Associate Director, Component Engineering, Merck & Co.
Ying Gao, Ph.D., Technical Support Specialist, Process Analytical & Development Group, Development & Production, Public Health England, United Kingdom
Daniel C. Vellom, Ph.D., Senior Director, Global Technology Innovation, Sanofi Pasteur Biologics
Russell Wong, Ph.D., Principal Engineer, Bayer Health Care
Weibing Ding, Ph.D., Principal Scientist, Materials Science, Amgen Inc.

5:15
Concurrent Product Showcases
A showcase of companies providing short presentations on cutting-edge technologies highlighting latest tools-of-the-trade to help improve productivity, increase reliability and reduce time-to-market for biologics. For more information contact Kristen Schott at (508) 614-1239 or kschott@ibcusa.com.

6:00
Networking Cocktail Reception in Poster and Exhibit Hall

Tuesday, June 10, 2014

7:30
Registration and Coffee

8:25
Chairman's Opening Remarks
Jeffrey Johnson, New Technology Lead, Merck & Co., Inc.

Innovative Process and Manufacturing Solutions

8:30
Case Study
A Closed Sterile System for Viral Vaccine Purification using Single-Use Technologies
The BioProcess R&D department at Sanofi Pasteur Canada fully embraced single-use technology when it was moved into bioprocessing around 10 years ago. Although many single-use items had been used for years in vaccine process development, the example of employing single-use technology to build a completely closed system for vaccine purification is novel. This presentation focuses on a case study with unique applications of single-use technology for purification of a viral vaccine.
Julia Telychko, MBiotech, Associate Scientist, BioProcess Research and Development, Sanofi-Pasteur Canada

9:00
New DataCase Study
Rational Selection and Capacity Improvement of Disposable Filters Used in the Downstream Processing of Biopharmaceutical Proteins
Many feed streams in the biopharmaceutical production of proteins, e.g. monoclonal antibodies, have to be clarified before the dissolved target can be isolated, e.g. by chromatography. Disposable filters offer a cost-effective, fast and safe way to achieve this goal. Here we present how adequate filters can be selected and which measures are suitable to improve capacity and reduce consumables costs.
Johannes Felix Buyel, M. Sc., Biology VII / Fraunhofer IME Integrated Production Platforms, RWTH Aachen University, Germany

9:30
Implementing Larger Pre-Packed Columns for GMP Manufacturing
Implementation of pre-packed disposable columns is increasing as the technology advances to deliver more options for GMP manufacturing operations which rely on disposable components. This presentation explores the new technological developments as well as the benefits of larger pre-packed chromatography columns.
Fletcher Malcom, MBA, Associate Director, Product Management, Repligen Corp.

10:00
Networking Refreshment Break in Poster and Exhibit Hall

10:40
Chairman's Opening Remarks
Mark A. Petrich, Ph.D., Associate Director, Component Engineering, Merck & Co.

Featured Presentation

10:45
Case Study
Alex Tschumakow Single Use Systems - An End User's Perspective
Shire, faced with the need to increase manufacturing capacity in a flexible way to meet growing demand for its commercial and clinical products, responded with construction of a state-of-the-art plant that maximized deployment of Single Use Systems (2011 ISPE Facility of the Year Honorable Mention). This talk will review the business case, the challenges associated with design and start-up, regulatory acceptance / approval, routine use of Single Use Systems, and some lessons learned along the way.
Alex Tschumakow, Director, Manufacturing, Shire

BPOG Initiative Updates

11:15
Collaboration Leading to Simpler, Faster, and Lower Cost Commercial Implementation of Single Use Technologies
Over the last decade, single-use technologies have rapidly become a technology of choice in biopharma and vaccine development and clinical production, however in commercial manufacturing where the requirements and risks are greater a number of concerns have emerged that are impeding adoption rates. While the innovative and entrepreneurial nature of single-use suppliers in the last decades was key to the industry's rapid rise, many now recognize that the next phase will be dominated by those who can deliver a fast and reliable supply solution. The BPOG group made up of single-use end users is keen to encourage these developments and believe they can help accelerate single-use commercial adoption rates by developing a set of clear and consistent customer requirements for supply chain improvement and product and service harmonization. This presentation will give an overview of the collaborative efforts between end users, suppliers and other organizations (BPSA, ASTM, ASME, etc.) and review the first level of detailed end user requirements from the BPOG collaboration.
Jeffrey Johnson, New Technology Lead, Merck & Co., Inc.

11:45
BPOG's Extractable Protocol Standardization Effort - Where Are We Now?
Abstract not available at time to print.
Ken M. Wong, MSc., MTech/AP&T, Extractables & Leachables, Sanofi Pasteur

12:15
Concurrent Technology Workshop presentations
For more information on Technology Workshop presentations, please contact Kristen Schott at 508-614-1239 or kschott@ibcusa.com

12:45
Networking Luncheon in Poster and Exhibit Hall

TOWN HALL FORUM
Harmonization of Single-Use Systems: Particulates

1:55
Moderator's Remarks
James Dean Vogel, Founder and Director, The BioProcess Institute

2:00
Status Updates from BPSA, ASTM, ISPE, PDA, BPOG and ASME BPE on Current Initiatives on the Assessment, Reduction and Control of Particulates
Panelists:
ASTM Perspective: Robert Steininger, Senior Vice President, Manufacturing, Acceleron Pharmaceuticals, Inc.
ISPE Perspective: Pietro Perrone, Chair of Disposables, Community of Practice - ISPE and Mobius Single-Use Systems Engineer, EMD Millipore
BPOG Perspective: Jeffrey Johnson, New Technology Lead, Merck & Co., Inc.
BPSA Perspective: Jerold Martin, Senior Vice President, Global Scientific Affairs, Pall Life Sciences
ASME BPE Perspective: TBD

3:00
Interactive Town Hall Discussion with Audience Participation

3:30
Networking Refreshment Break and Last Chance for Poster and Exhibit Viewing

3:45
Passport Drawing in Poster & Exhibit Hall

4:00
Poster & Exhibit Hall Closes

Assessment, Reduction and Particulate Control

4:00
Silicone Tubing Extractables and The Connection to Particulates
This presentation recommends study designs for silicone tubing and discusses how particulates and extractables are related. Many factors need to be considered in the extractables study design: solvent choice, testing conditions including time, temperature and agitation, surface area to volume ratio, wall thickness, selection of analytical techniques, detection/quantitation limits, and expression of results. Along with the evaluation of particulates originating from tubing, capture and counting methods must be closely controlled to obtain reproducible and relevant data. Parameters such as nature of flow, storage of effluent and tubing treatments can dramatically impact results. The situation is complicated by the fact that most of the particles encountered are liquid origin and therefore unstable in terms of shape, size, and availability. Light obscuration and microscopic experiments will be discussed which have helped us evaluate particle size distributions and the proportions of liquids and solids, as well as understand the effects of the conditions used to prepare the effluent before it is analyzed.
Csilla Kollár, MS, Technical Specialist, Silicone Solutions for Pharma Processing, Dow Corning

Featured Presentation

4:30
Peter Rogge Designing a Facility for Maximum Flexibility: A Three Years-Experience in Full Plastics
The consistent and integrated use of disposable technologies enables fast and reproducible GMP manufacturing and allows a significant cost reduction for clinical supply. In 2010, Rentschler successfully implemented the first 1000 L disposable manufacturing line, and was awarded with the "Facility of the Year Award" for its second 1000 L fully disposable manufacturing line. Over the last three years Rentschler has successfully executed a significant number of various customer's processes in its 1000 L fully disposable manufacturing area. Continuous improvement and optimization of the facility and its processes has made the utilization of disposable technologies more robust and effective. The presentation will focus on the gained experience, lessons learned, current and remaining challenges. Subjects as Leachables and Extractables, Material Flow, Maintenance, Difficulties in Operation, will be addressed.
Peter Rogge, Vice President USP Production, Rentschler Biotechnologie GmbH, Germany

5:00
Close of Single-Use

BPI 2014