Manufacturing Strategy Agenda

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Manufacturing Strategy

Tuesday, September 17, 2013

Symposia: Monday | Courses | Main Conference: Tuesday | Wednesday | Thursday

7:00

Registration and Coffee

8:00

Chairwoman's Opening Remarks
Ran Zheng, Executive Director, Plant Manager, Amgen Inc.

Maximizing Manufacturing Efficiencies and Capacity Utilization

8:15

Over the Horizon: How a Large-scale Single-product Facility Reshaped Its Future
Biomanufacturing industry has experienced sea changes in recent years. Cell culture titers get higher, processes become more robust, single-use and other innovative technologies are coming of age. At the same time, the market uncertainties and global competition become more intensified. Together these converging forces present significant disruptions to today's business. In this presentation, strategies to transform a large-scale single-product facility to a multi-product high throughput operation will be discussed. Innovative approach and best practices to maximize flexibility and efficiency will be illustrated.
Ran Zheng, Executive Director, Plant Manager, Amgen Inc.

8:45

Case
Study

Implementing and Improving Disposable Systems in BioMarin's Manufacturing Environment to Meet Growing Capacity
Chris M. Brodeur, Associate Director, Commercial Operations, BioMarin

9:15

Maximizing Efficiencies and Capacity Utilization in a Multi-Product Clinical and Commercial Facility
John Kenneally, Director, Drug Substance Manufacturing, Genentech, Inc.

9:45

Networking Refreshment Break

Manufacturing Strategy and Planning

10:15

Case
Study

A Case Study in Creation of a Strategic Technical Lifecycle Plan (TLCP) for Continuous Improvement of a Legacy Biological Process
This case study describes creation of an integrated work plan of major process improvement projects and product lifecycle milestones, called the technical lifecycle plan (TLCP), for a legacy product approved in 1990s. The process at present had throughput bottlenecks, inefficient operations and raw material continuity related risks. Creation of the work plan was initiated by formation of a technical team consisting of all stakeholders. Project prioritization based on KPIs and analysis of interaction between the projects led to grouping of projects into distinct programs. Subsequently, the TLCP was resource loaded and leveled to enable technology transfer to a new facility.
Naveen Pathak, Associate Director, Technical Strategy, Manufacturing Science & Technology, Genzyme, a Sanofi Company

10:45

Creating Manufacturing Efficiencies in a 24/7 Commercial Facility Using Perfusion Technology: Challenges and Lessons Learned
Thomas Bamberger, Operations Manager, Bayer Healthcare

11:15

Biosimilars Development Pathway
Sourav Kundu, Ph.D., Director, Biopharmaceutical Development, Teva Biopharmaceutical USA

Concurrent Technology Workshops

11:45

Toolbox Strategies for a Diversity of MAbs
High-titer feed-stocks and an increasing demand for separation of MAb variants (aggregates, fragments, charge variants, etc.) call for chromatography resins with new features. The focus here is to develop strategies for post Protein A polishing of various MAb purification challenges. New polishing resins, both ion-exchange and multi-modal resins, with high resolution will be compared regarding binding/elution conditions and ability to separate MAbs from impurities. Depending on the level of impurities, different processes including one or two polishing steps will be proposed.
Mats Gruvegard, Bioprocess Project Leader, GE Healthcare Life Sciences

Title TBA
Speaker TBA

The Smart Way to Optimize Virus Filtration Steps
Current biomanufacturing processes have reached a high degree of standardization and companies are working on the basis of proven technology platforms. While this helps to set up new purification trains in short timeframes, virus clearance concepts still require a thorough optimization to address economic challenges and product related characteristics. The tool box is getting bigger with different membrane types and features, different pre - filtration methods as well as product conditioning. This presentation will focus on different ways to optimize virus filtration to end up with a most efficient step.
Anika Meyer, Product Manager Virus Clearance, Sartorius Stedim Biotech GmbH, Germany

Luncheon Presentation (Space is limited)

12:15

Strategic Discussion and Brainstorm Session

1:45

In cooperation with:

How to Maximize your Limited Bandwidth for Beta Testing of Bioprocess and Biomanufacturing Technologies?
Beta testing is one of the key steps to technology adoption. Yet, with decreasing budgets and headcounts companies are finding less resources to pursue activities not on the critical path to getting products to licensure. This is compounded by the ever increasing number of new technologies that a company must consider and the higher hurdle to adoption in the world of platform processes. This session explores how companies prioritize and streamline their Beta Testing and the potential roles of consortia and vendors in getting the critical data to fully evaluate a new technology or process step.
Moderator: Peter Latham, President, Latham BioPharm Group
Panelists:
Brian Caine, Publisher, BioProcess International
David W. Kahn, Ph.D., Senior Director, GlaxoSmithKline
Charles Sardonini, Ph.D., Associate Director, Process Engineering/Development, Genzyme, a Sanofi Company

3:15

Grand Opening of the Poster and Exhibit Hall with Refreshments Sponsored by

Keynote Presentations

4:00

Chairman's Remarks
Rohin Mhatre, Ph.D., Vice President, BioPharma Development, Biogen Idec

4:15

Producing High Quality, Low Cost Biotherapeutics in the Century of Biology
Over the last 30 years there have been substantial advancements in the manufacture of protein therapeutics. For example, product titers have been increased by more than four orders of magnitude using mammalian expression systems. Today we have the capability of producing metric tons of relatively low cost complex biologics; enough to meet the most demanding therapeutic markets. While some believe our advancements in this field are reaching a plateau, the century of biology will provide the knowledge and tools for even greater innovation for those willing to invest.
James Thomas, Ph.D., Vice President, Process and Product Development and WA Site Head, Amgen, Inc.

4:50

A Systems Approach to Managing Biomanufacturing Complexity - Genzyme's Allston Plant Case Study
Sandra Poole, Senior Vice President Biologics Operations, Genzyme

5:25

Transforming the Development of Biotechnology Drugs for the 21st Century: A CEO's Perspective from a Small Biotech Company
In these times of growing unmet medical need driven innovation in drug development is needed more than ever. Rapid translation of ideas into high value drugs that move rapidly from the bench to the bedside requires the perfect blending of science, medicine, policy and capital. While efficacy and safety will continue to be the key drivers of value, other factors driving healthcare impact, outcomes and cost will have to be more proactively integrated into drug discovery and drug development. The small biotech company will continue to be a critical component of the solution to these challenges.
Abbie Celniker, Ph.D., CEO, Eleven Biotherapeutic

6:00

Wine and Cheese Reception in Poster and Exhibit Hall Sponsored by

Wednesday, September 18, 2013

Symposia: Monday | Courses | Main Conference: Tuesday | Wednesday | Thursday

7:30

Coffee

Technology Workshop with Light Continental Breakfast

7:30

Implementing Disposable Chromatography: Technology Fit in Downstream Purification
While single-use and disposable technologies are prevalent in many areas within upstream and downstream processing, up until now there has not been a broadly applicable solution for chromatography steps. In this presentation, best practices for implementing pre-packed disposable columns in clinical manufacturing will evaluated, and a case study from a recent GMP manufacturing implementation will be presented.
Stephen Tingley, Vice President, Bioprocessing, RepliGen

8:00

Chairman's Remarks
Dean Pettit, Ph.D., Executive Director, Process and Product Development, Amgen, Inc.

Product Attribute Control (PAC): A Future Vision for Protein Process Development and Manufacturing

The development and manufacturing of biopharmaceuticals has historically been a challenging and expensive process over the lifecycle of the product. Typically, processes need to be scaled up and improved as product requirements increase, potentially leading to changes in product attributes and comparability risks that must be managed, with significant time and scientific effort required to address the issues and risks encountered on each individual project. Given the immense complexity and molecular heterogeneity of many biopharmaceuticals, it has been very difficult to maintain an exact profile of product attributes, or to know which of these attributes are clinically relevant. Scientific and technological advances have suggested that the development and manufacturing paradigm of the future could be freed from the constraints of the past, with a greater understanding of 1.) attribute criticality; 2.) the relationship of manufacturing process design/conditions to product attributes and 3.) the ability to assure reliable control of product quality for patients. This session will highlight key examples of advances in these areas, followed by an interactive discussion of the potential of these approaches to fundamentally transform process and product development for biopharmaceuticals.

Unpublished Data

8:15

Determining the Attributes of Aggregated Biotherapeutics and their Potential Biological Consequences
Marisa Joubert, Ph.D., Senior Scientist, Product Attribute, Sciences, Amgen, Inc.

8:45

Connecting Product Attributes with Process Steps
Brian Collins, Ph.D., Director, Protein Sciences, Momenta Pharmaceuticals

9:15

CHOGenome.org - Infrastructure to Support the Next Generation of Development in Biopharmaceuticals
Many biopharmaceuticals are produced in Chinese hamster ovary (CHO) cells. The CHO K1 cell line is an ancestor to many production cell lines and was recently sequenced. We will discuss the aspects of the international community's efforts at developing an infrastructure to support, host, and disseminate genome-scale data related to CHO cell lines.
Kelvin H. Lee, Ph.D., Gore Professor of Chemical Engineering, Delaware Biotechnology Institute Faculty Fellow, University of Delaware

9:45

Networking Refreshment Break in Poster and Exhibit Hall Sponsored by

Flexible Facilities, Multi-product Manufacturing and Single-Use Implementation: Practical Experiences and Lessons Learned

Session Chairman: Jerold Martin, Senior Vice President, Global Scientific Affairs, Pall Life Sciences

10:30

Case
Study

Facility of the Future - Single Use Facility, A Case Study from Biogen Idec
In 2012, Biogen Idec completed its first single use disposable manufacturing facility named FVM (Flexible Volume Manufacturing). This new manufacturing facility incorporated many innovative designs and seamlessly integrates operations into its existing facility in RTP (Research Triangle Park). This case study will highlight some of the design feature and intent, compare the cost of construction of this facility vs. comparable traditional stainless steel facility, and finally some lessons learned from its first campaign.
Chien Lin, Senior Manager, Process Engineering, Global Project Engineering, Biogen Idec, Inc.

11:00

Case
Study

Multiproduct Facility Operations - Technologies, Efficiencies and Continuous Improvement Culture
Many challenges are faced in a multiproduct facility including schedule, resources, equipment utilization and product mix. This presentation will review the lessons learned, technology and methodology utilized by CMC to best utilize its production facilities including implementation of a Continuous Improvement culture to support improvements at the grass roots level.
Bob Munday, Vice President, Technical Operations, CMC Icos Biologics, Inc.

11:30

Single-use Single-pass TFF: An Approach to Diafiltration
Single-pass TFF technology can be used to concentrate protein solutions 3 - 30X in a single pump pass. Ideally suited to single-use operation, the technology results in more compact systems than traditional TFF due to its reduced feed flow rate requirements and simple control methods. Performing diafiltration (DF) in a single-pass mode presents an engineering challenge. A DF approach is presented where the initial concentration is performed in single-pass mode allowing linkage with the previous process step to decrease the overall process time. The DF operation is then performed in a recirculation mode to achieve the appropriate buffer exchange with minimal additional hardware. Following DF, the resulting material is concentrated in single-pass mode to the final formulation conditions. Data is presented comparing this new DF single-pass TFF approach with a conventional TFF operation in terms of process economics, pump passes, final product concentration and yield, and illustrating the completely single-use flow paths that can be used.
Jon Petrone, Vice President, Americas Biopharm, SLS Global Technical Support, Pall Life Sciences