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The Industry's #1 BioProcessing Event

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BioProcess International Conference & Exhibition

Conference: October 20-23, 2014 * Exhibition: October 21-23, 2014 * John B Hynes Veterans Memorial Convention Center, Boston, MA

1,500+ Attendees - 160+ Speakers - 150+ Exhibitors

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

Conference: October 20-23, 2014 · Exhibition: October 17-19, 2014 · John B Hynes Veterans Memorial Convention Center · Boston, MA

Pre-Conference Symposia Agenda

Pre-Conference Symposia Agenda

Pre-Conference Symposia

Monday, October 20, 2014 · Pre-Conference Symposia

Symposium #1

Innovation through Integrated Process Development

8:00
Registration and Coffee

9:00
Chairman's Opening Remarks
Ganesh Vedanthum, Ph.D., Director, Process and Product Development, Amgen

9:15
Case Study
A Future Without Columns
This presentation will describe an integrated clarification-magnetic nanoparticles purification process for IgG that achieves the same purification performance as protein A but with 1000 times higher capacity per mL of particles.
Pete Gagnon, M.S., Group Leader, Downstream Processing, Bioprocessing Technology Institute, Singapore

9:45
Alternative Separation Technologies for the Harvest of CHO Cell Culture
Continued improvements in process yields will require higher cell densities and cell mass The cellular mass generated throughout the course of production can be in excess of 20% based on packed cell volume (PCV); beyond the capabilities of a typical disk stack centrifuge to harvest. The increased solids coupled with the desire for disposable processing have necessitated the investigation of alternative methods of CHO culture harvest. Two methods in particular have shown promise: Flocculation followed by cell settling and the use of Aqueous Two Phase Systems (ATPS). This presentation will discuss the performance of these technologies with a focus on yield, robustness, and their impact on product quality.
Rob Piper, Principal Scientist, Amgen

10:15
Case Study
Integrating AEX Hybrid Purifier Enables Two-Stage Chromatography Purification of Recombinant Therapeutic Antibodies
The demonstration of virus clearance during multi-step purification is an integral part of ensuring the safety of Biopharmaceutical drug products. Besides Protein A and cation exchange (CEX) chromatography, anion exchange (AEX) chromatography or AEX membrane adsorbers are commonly used for both reduction of process-related impurities as host cell protein (HCP) and DNA and virus clearance orthogonal to pH-induced virus inactivation and virus filtration. In the presented case study, different types of 3M's AEX Hybrid Purifier systems (ZetaPlus and Emphaze) were characterized with regard to their adsorption capacity based on the positively charged surface combined with their membrane filtration capacity. The results clearly demonstrate the high potential of the AEX Hybrid Purifier to significantly reduce HCP, DNA and virus. Substituting conventional depth filtration and final polishing with one innovative unit operation enabled to set up Rentschler's antibody purification platform as a two-stage chromatography process.
Dethardt Müller, Ph.D., Vice President, Technology Development, Rentschler Biotechnologie GmbH, Germany

10:45
Networking Refreshment Break

11:15
Integration of Novel Purification/Separation Technologies to Handle the Highly productive Cell-Culture Processes
The advent of highly productive cell-culture processes for the production of recombinant proteins provides an opportunity to redesign and redevelop traditional separation and purification unit operations to handling increased titers. Additional demands to maintain similar facility footprints have driven highly integrated process trains. We will be discussing a number of options for increasing throughput in existing Facility footprint using a combination of novel high binding and Size separation capacity technologies in conjunction with non-conventional process integration techniques.
Jonathan K. Romero, Ph.D., Associate Director, Operations, Technology Innovation, Global Engineering, Biogen Idec

11:45
Case Study
Integrative Themes in Bioprocess Innovation
Several Innovative themes have recently emerged in the bioprocessing arena that involve the integration or intensification of conventional unit operations by serving more than one purpose at a time. Case study include the use of cell culture media additives that boost titer as well as decrease product degradation, multipurpose chromatographic steps and harvest schemes that remove significant amounts of process related impurities.
Abhinav Shukla, Ph.D., Vice President, Process Development and Manufacturing, KBI Biopharma

12:15
Lunch on your own

2:00
Characterization of a Novel Purification Medium - Emphaze AEX Hybrid Purifier from 3M
Advantages of using Emphaze Hybrid Purifier in the upstream cell clarification step to separate a mAb were evaluated for different feed stream conditions of pH and conductivity and compared to current processes. Results show that by incorporating Emphaze into the harvest process, significantly lower levels of HCP, DNA and turbidity were observed, rendering a more robust mAb production process.
Javier Garcia, Scientist II, Upstream Process Development, Bristol-Myers Squibb

2:30
Use of a Novel Multi-Mechanism Clarification Device for Simultaneous Filtration and Purification of Process Intermediate Pools During Monoclonal Antibody Purification
A novel multi-mechanism clarification device, the Emphaze™ AEX Hybrid Purifier, was evaluated for its potential to combine filtration of turbid in-process intermediates with removal of bulk process-related impurities. The robustness of the performance of the device to variation in feedstream and operating parameters was demonstrated with a number of different monoclonal antibodies while optimizing pH, conductivity and through-put.
Andrew D. Tustian, Eng.D, Senior Staff Engineer, PreClinical Manufacturing & Process Development, Regeneron Pharmaceuticals Inc

3:00
Networking Refreshment Break

3:30
Talk Title TBD
Takeda Vaccines Presenter

4:00
Enabling Next Generation of Bio-Pharmaceutical Purification Through Innovative Process Technologies
The blinding pace of drug discovery and the depths of bio-pharmaceutical candidate pipelines drive the critical need for higher and higher performance and lower cost manufacturing processes. With its broad advanced materials technology platforms, close collaborations with bio-pharma market leaders, and holistic approach to bio-process development, 3M is creating novel bio-process solutions that enable qualitatively higher performance of the next generation of bio-pharmaceutical purification processes.
Alexei M Voloshin, Ph.D., MSc., Global Scientific Services Leader, Life Science Process Technologies, 3M Purification Inc

Panel Discussion:

4:30
Opportunities for More Holistic Approach to Biopharmaceutical Purification
Moderator:
Ganesh Vedanthum, Ph.D., Director, Process and Product Development, Amgen
Panelists:
Pete Gagnon, M.S., Head of Downstream Processing, Bioprocessing Technology Institute, Singapore
Abhinav Shukla, VP, KBI Biopharma
Andrew Sandford, VP Global Business Development, Catalent
Rahul Singhvi, COO, Takeda Vaccines

5:00
Close of Symposium

Symposium #2

Cell Therapy Bioprocessing

8:00
Registration and Coffee

9:00
Chairperson's Opening Remarks - How We Got Here, Where We are Going, and What We Need to Get There
Jon Rowley, Ph.D., Chief Executive & Technology Officer, RoosterBio Inc.

Product Development and Commercialization Strategies

Featured Presentation

9:15
Trends and Developments in the Quest to Turn Living Cells into Tomorrow's Therapeutics
Ever since cells could be cultured ex vivo there has been the potential to develop cellular therapies that could repair, regenerate and even cure cancer. Increasing biological knowledge allows us to grow pluripotent cells and harness the body's own mechanism for repair through paracrine signaling or by genetically engineering T cells to unlock the tumor killing capabilities of T cells.
Ian R. Harris, Ph.D., Senior Director, Cell Therapy, Janssen R&D

9:45
Best Practices in Cell Therapy Process Development - A Framework for Designing Effective Multi-Year Process Development Programs
As Cell Therapy is evolving as a field and technical discipline, bioprocessing strategies and technologies are being utilized to scale-up, scale-out and streamline manufacturing processes to position them for commercial success. However, as Process Development is a discipline learned on the job, and not at University, there are few references that cover many of the best practices used in the field - and fewer available that discuss Cell Therapy-specific requirements. This talk will cover several best practices in Cell Therapy Process Development that have evolved over the past few years, and provide a framework in which to design highly effective multi-year process development and manufacturing plans that span across clinical development and through to commercialization. The goal is to achieve commercially-relevant manufacturing processes that deliver products at costs that allow for commercial success.
Jon Rowley, Ph.D., Chief Executive & Technology Officer, RoosterBio Inc.

10:15
Industrialization of a Cell Based Therapy Process - How to Identify the Right Technological Strategy?
Cell-based therapies are gearing up to have extensive impact on the healthcare field. This has set the stage for high productivity manufacturing technology with an emphasis on adherence to GMP standards while controlling cost of goods. Scale-up is not as simple as providing a larger surface area. Changing the niche environment has a big impact on cell behavior. The scale-up strategies from R&D to industrial production must preserve the integrity and quality of the cells. The presentation will cover the technological options and related challenges that are currently available. Particular focus will be made on the impact on the time-to-market.
Matthieu Egloff, Product Manager, Pall Life Sciences, Belgium

10:45
Networking Refreshment Break

Process Development and Optimization Methodologies

11:15
New Data
Scale Considerations for Allogeneic Cryopreserved Cell Therapies
Our approach to scale-up focuses on three key steps: (1) identifying cellular responses and failure modes, (2) developing process understanding around critical parameters at the current scale, and (3) applying engineering principles to define scale-up parameters and to predict success at the next scale. Examples are given from multiple stirred-tank bioreactor scales, kSep centrifugation, and cryopreservation.
Brian Murphy, Ph.D., Director of Bioprocess Development, Celgene Cellular Therapeutics

11:45
Process Design for Manufacturability of Patient Specific Products
Jason N. Carstens, Ph.D., Director, Process Development, Fred Hutchinson Cancer Research Center

12:15
Light Lunch

Utilizing Proven CMC and Product Characterization Approaches

1:30
Designing a CMC Strategy for Cell and Gene Therapy
Defining a CMC strategy is a key element to successful product development, regardless of product type. In recent years, the implementation of the A™P regulation and guidelines together with the new quality paradigms developed in ICH guidelines (Q8-10), and the refinement of GMP requirements (Annex 2), all encourage science and risk based approach to become an integrated part of product development. Identifying the CMC regulatory requirements at any given development stage provides the opportunity to reflect on the product, its specific characteristics and the potential technical challenges or limitation that one may face during the course of development. This set of information will be critical in defining the needs in terms of product characterization tools, production scales, comparability plans, risk mitigation etc and will help drive priorities and efforts throughout development.
Valerie Pimpaneau, Ph.D., Senior Director, Voisin Consulting Life Sciences

2:00
Establishing Product Specifications in Late Stage Development
Robert J. Deans, Ph.D., Executive Vice President, Regenerative Medicine, Athersys, Inc.

2:30
Networking Refreshment Break

Successful Scale Up and Manufacturing Strategies

3:00
The Road Not Taken.... Moving Cell Therapy from the Benchtop to an Industry
The need for large quantities of cells with high quality becomes crucial as more therapies move in to clinics. High quantities of cells opens new questions and challenges of cell quality, identity, reproducibility and cost. Bioreactor technology brings to the cell therapy industry the opportunity to manufacture large quantities of cells in a tightly controlled and monitored manner, lowering relatively the cost of goods manufactured resulting in a product and process for cell therapy commercialization. The talk will describe some of the main challenges accounted during the development of the GMP manufacturing technology for PLX (PLacental eXpanded) cell product candidates and some of the bottlenecks opening methods developed in Pluristem's pilot and manufacturing facilities.
Ohad Karnieli, Ph.D., MBA, Vice President, Development & Manufacturing, Pluristem Therapeutics, Inc.

3:30
Case Study
Challenges of Scale in Cell Therapy Manufacturing
Moving a promising cell therapy from the initial discovery phase through to clinical trials and therapeutic delivery poses a number of challenges. Not only must an evolving process clear regulatory hurdles and scale to meet dose and lot size requirements but it must also maintain economic value. In addition to discussing these challenges a number of case studies will be presented to describe how process development and economic goals were achieved in both industry and academic settings including ReGenesys and Baylor College of Medicine. Particular attention will be directed toward the process changes ofter needed to meet these goals. In addition, viral vector production and dendritic cell maturation methods using the Quantum Cell Expansion System for use in gene therapy and immune therapy will be discussed.
Jim Beltzer, Ph.D., Senior Cell Processing Specialist, Cell Processing, Terumo BCT

4:00
New Data
New Tricks with Old Tools - Applying Cell Culture Engineering Tools for Cell Therapy Manufacture
Many existing tools and technologies from biopharma are applicable to cell therapy manufacture, but are often overlooked. This seems to be driven by a lack of familiarity or perceived complexity of application to cell therapies. In reality, these tools/technologies are necessary to the industrialization of cellular therapies, and with a bit of tweaking and insight, can be effectively adapted without re-inventing the wheel.
Nick Timmins, Ph.D., Director, Product and Process Development, Centre for Commercialization of Regenerative Medicine (CCRM)

4:30
Panel Discussion - Developing Cell Therapies in Big Pharma/Biotech
Moderator:
Lee Buckler, Founder and Managing Director, Cell Therapy Group
Panelists:
Robert J. Deans, Ph.D., Executive Vice President, Regenerative Medicine, Athersys, Inc.
Ohad Karnieli, Ph.D., MBA, Vice President, Development & Manufacturing, Pluristem Therapeutics, Inc.
Brian Murphy, Ph.D., Director of Bioprocess Development, Celgene Cellular Therapeutics
Nick Timmins, Ph.D., Director, Product and Process Development, Centre for Commercialization of Regenerative Medicine (CCRM)

5:00
Close of Symposium

Symposium #3

Antibody-Drug Conjugates - Developing ADC Technologies to Increase Therapeutic Windows

8:00
Registration and Coffee

9:00
Chairperson's Opening Remarks
Morris Rosenberg, Ph.D., Principal Consultant, MRosenberg BioPharma Consulting

Featured Presentation

9:15
The Evolution of ADCs: Lessons Learned from the Past. Where are We Going?
Robert Lutz, Ph.D., Vice President, Translational Research and Development, ImmunoGen, Inc.

Developing ADC Technologies to Increase Therapeutic Windows - Part 1

9:45
Case StudyNew Data
Off-Target Toxicities of Highly Targeted Antibody Drug Conjugates: Risk Mitigation Strategies
Rakesh Dixit, Ph.D., DABT, Vice President, R&D; Head, Global Safety Assessment, MedImmune (AstraZeneca Biologics)

10:15
Case StudyNew Data
A Universal Chemically Driven Approach Toward the Synthesis of Homogeneous ADC's
Paul Sauer, MBA, Vice President, Process Development, Igenica Biotherapeutics

10:45
Networking Refreshment Break

11:15
Analytics of Disulfide Conjugated vs Site-Specific Conjugated ADC
Brian Wiggins, Principal Associate, Analytical and Formulation Development, Agensys, Inc.

11:45
Homogeneous and Stable ADCs by Chemoenzymatic Glycan Remodeling-Conjugation
Sander S. van Berkel, Ph.D., Chief Technology Officer, SynAffix B.V., The Netherlands (invited)

12:15
Light Lunch

Developing ADC Technologies to Increase Therapeutic Windows - Part 2

1:30
Site-Specific Approaches to Conjugation: Advantages beyond Homogeneity
Arvind Rajpal, Ph.D., Vice President, Rinat - Pfizer (invited)

2:00
Case StudyNew Data
Generation of ADCs Conjugated Site Specifically with Distinct In Vivo Efficacy and PK Outcomes
Redwood Bioscience, Inc. has developed the SMARTag™ technology platform that enables precise, programmable, site-selective chemical protein modification and stable bioconjugate generation. Leveraging the target sequence of Formylglycine Generating Enzyme (FGE), proteins are chemoenzymatically modified to generate a precisely placed aldehyde functionality that can be chemically elaborated using the hydrazino-iso-Pictet-Spengler (HIPS) ligation. Data from preclinical tumor models, PK studies and toxicology studies highlighting the efficacy and safety of these ADCs and will be presented.
David Rabuka, Ph.D., Chief Scientific Officer and Founder, Redwood Bioscience

2:30
New Data
Superior Efficacy with Homogeneous ADCs Requires Selection of Optimal Site and is Dependent on Linker and Warhead
Trevor J. Hallam, Ph.D., Chief Scientific Officer, Sutro Biopharma, Inc.

3:00
Networking Refreshment Break

Scale Up and Manufacturing ADCs

3:30
Engineered Cysteine mAbs and PBD Dimers: ADC Manufacturing Experience
Ruth F. Moser, M.S., Scientist, Purification and Conjugation Development, Seattle Genetics

4:00
New Data
Challenges of Outsourcing ADCs - Managing all the Outsourced Components - Perspectives from the Client
The conjugation process is complex and involves development and transfers for both large and small molecules. Some manufacturing challenges will be discussed.
Deborah Meshulam, M.S., Director, Contract Manufacturing, ImmunoGen, Inc.

4:30
Case StudyNew Data
Choosing and Optimizing a Scalable Conjugation Process for Development
Wenjie Cheng, Ph.D., Senior Scientist, Process Science and Engineering, ImmunoGen, Inc.

5:00
Close of Symposium

Symposium #4

Knowledge Management across the Product and Process Lifecycle

8:00
Registration and Coffee

9:00
Chairperson's Opening Remarks
Jose Menezes, Ph.D., Professor, Institute for Biotechnology & Bioengineering, Technical University of Lisbon, Portugal

Methods and Tools for Knowledge Management

9:15
Case Study
A State-of-the-art Information Management System to Improve Bioprocessing Knowledge Management and Decision-making
Andreas Schneider, Vice President, International Business Leader Custom Biotech, Roche Diagnostics International Ltd., Switzerland

9:45
Knowledge Management and Process Understanding: Putting the Pieces Together
Joseph A. Horvath, Ph.D., Senior Director, Quality Systems, Takeda Pharmaceuticals International

10:15
Risk-Analysis and Knowledge-Management: New Tools and Approaches for the Bio/Pharma Industries
Jose Menezes, Ph.D., Professor, Institute for Biotechnology & Bioengineering, Technical University of Lisbon, Portugal

10:45
Networking Refreshment Break

Knowledge Management Applications in BioPharma Development and Manufacturing

11:15
Case Study
A Practical Approach to Managing Knowledge - A Case Study at Merck
Knowledge is a critical "product" in today's business yet is seldom managed as an asset delivering value to many business objectives, including improved customer service and quality, financial and operating benefits, and higher employee engagement. This case study will highlight the journey of Merck Manufacturing to create a strategy for managing knowledge, including supporting principles and early outcomes.
Martin J. Lipa, Executive Director, Knowledge Management, Merck Manufacturing Division

11:45
The Needle in the Haystack: Actionable Insight Gleaned from Historical Data Improves Commercial Enzyme Product Output
Optimizing an established regulated pharmaceutical process within filed validated ranges is an ongoing biomanufacturing challenge. Historical data from measured process parameters of established bioprocesses are typically plentiful, yet effective tools to uncover subtle correlations impacting key product outputs are at best sparse. Furthermore, even if an effective improvement from a process parameter change is uncovered a noticeable effect is likely to be outside filed ranges. In such a circumstance, additional regulatory hurdles for the process change would need to be met. The targeted commercial enzyme cell culture process is a microcarrier-based continuous perfusion process for the production of an enzyme associated with a rare disease. This targeted cell culture process has been producing enzyme commercially for over a decade. It proved to be the ideal candidate for a historical data based process improvement strategy. More than a dozen process parameters spanning the complete manufacturing process and representing 50 bioreactors over a decade were collated and then unfolded into time linked and time-independent parameter to parameter correlations. Correlations in the hundreds of thousands were visually depicted in color coded correlation diagrams and confirmed by additional multivariate methods. From this analysis for the commercial enzyme manufacturing process, a process parameter to product out parameter correlation was uncovered. This correlation, when implemented, was found to have a quantifiable and predictable positive impact. Remarkably, a significant improvement to product output could be obtained by adjusting a process parameter within its filed range.
Rick Baggio, Ph.D., Senior Process Engineer, Therapeutic Manufacturing and Development, Genzyme Corporation

12:15
Case Study
Building Knowledge Management (KM) Solutions Today, Answer Questions Tomorrow
Sejal Mehta, Project Manager, Process Validation and Knowledge Management, Genentech, a Member of the Roche Group

12:45
Light Lunch

2:00
Knowledge Management and Its Role in Operational Excellence
Richard Welch, Senior Manager, Operations Performance Excellence, Knowledge Management, Amgen

Knowledge Management and Supply Chain/Raw Materials

2:30
Rx-360 Upstream Supply Chain Security: A Knowledge Management Approach to Mitigate Risk and Enhance Transparency
Rob Welsh, Vice President Category Management - Production Chemical Operations, VWR International LLC & Rx-360 Supply Chain Security Upstream Working Group Member
Ken Crossley, Manager of Quality Assurance and Supplier Quality Management, VWR International LLC & Rx-360 Supply Chain Security Upstream Working Group Member

3:00
Networking Refreshment Break

Knowledge Management, Continued Process Verification and Continuous Improvement

3:30
Case Study
Are your Processes in a State of Control? Implementation of CPV for Biological Processes- Past, Present and Future
According to ICHQ10 and FDA guidance on process validation, a lifecycle approach of continued process verification must be established. This involves business processes, quality systems and tools for continuous monitoring of process performance and product quality to ensure a state of control. The process of setting up a process monitoring program and incorporating in to Quality systems is established. The end result is alignment of business processes and quality systems, improved compliance, business efficiency and removed redundant efforts. Knowledge Management for CPV process including challenges will be discussed. Implementing multivariate statistical process control to simultaneously monitor multiple variables, process steps, and their interactions to detect weak signals.
Syama Adhibhatta, Senior Manager, Process Engineering and Development, Genzyme Corporation

4:00
Intelligence Based Manufacturing - The Future of BioPharma Manufacturing is Now!
What if our manufacturing processes were the repositories of process knowledge? What if all the data from our manufacturing and enterprise systems flowed seamlessly throughout the organization, allowing us to continuously build new understanding and improve our operations? What if our processes could proactively and automatically self-adjust to improve performance? What if this transformation was happening now? Pfizer is pursuing Intelligence based Manufacturing (IbM) to enable a step change in performance through a holistic integration of data, knowledge, and predictive models, at the process, plant, and enterprise level, throughout the product lifecycle.
Barak Barnoon, Director, Process Engineering & Analytics, Global Technology Services, Pfizer

4:15
Panel Discussion
  • What are the gaps, roadblocks and challenges in capturing, managing and effectively using Knowledge Management?
  • How can Knowledge Management efforts support more sustainable business models for biopharma?
  • Can investigations be triggered simply because Knowledge Management provided us additional detection capabilities?
  • Knowledge Management: nice-to-have or really a must-have coming of age?
Moderator:
Jose Menezes, Ph.D., Professor, Institute for Biotechnology & Bioengineering, Technical University of Lisbon, Portugal

5:00
Close of Symposium

Symposium #5

Optimize Processes and Improve Raw Materials Continuity and Transparency

8:00
Registration and Coffee

9:00
Chairperson's Opening Remarks

Ensure Supply Chain Transparency Through Better Data

9:15
A Program to Better Trace Raw Materials from Their Origin to Your Front Door
  • Learn why raw materials traceability is becoming more relevant in biotech
  • Get introduced to the International Serum Industry Association's traceability certification program
  • Find out what traits to look for in a supplier to ensure a collaborative relationship
Rosemary J. Versteegen, CEO, International Serum Industry Association

9:45
Case Study
How Amgen Organizes Around Raw Material Transparency
  • Explore supply chain steps taken by Amgen to increase transparency
  • Find out what FDA auditors look for with raw materials transparency concerns
  • Discover how to increase your company's regulatory oversight of raw materials
Patricia Turney, Executive Director, Raw Materials and Device Supply Chain, Amgen

10:15
New Data
Strategies for Raw Material Characterization
Chandana Sharma, Ph.D., Principal Scientist, Cell Sciences and Development, SAFC

10:45
Networking Refreshment Break

Solve Risk Management Challenges

11:15
Documenting the History of Cell Substrates in Your Supply Chain
  • Explore what information and documents to collect as part of cell substrate history
  • Learn best practices on how to review documentation on a timely basis
  • Discover new information you may not have collected that the FDA could request
Debra Barngrover, Ph.D., R.A.C., Senior Consultant, Biologics Consulting Group

11:45
Details Behind a Successful Second-Sourcing Program
  • Learn how to integrate second-sourcing options from the beginning with new suppliers
  • Find out how to revisit back-up supplier arrangements with legacy products
  • Explore the resource costs associated with second-sourcing efforts
Patricia Turney, Executive Director, Raw Materials and Device Supply Chain, Amgen

Assess the Performance of Your Processes

12:15
Fine-Tune Life Cycle Management with Raw Materials
Robin Hyde-DeRuyscher, Ph.D., Associate Director, Manufacturing Sciences, Biogen Idec

12:45
Light Lunch

2:00
Scalability of Complex Upstream Raw Materials
  • Learn about critical risk management attributes for your processes and whether suppliers have the ability to control them during scale-up
  • Find out about supplier pilot-scale production processes and how those processes differ from large-scale ones
  • Hear about supplier raw materials and whether sub-suppliers will change as volume demand increases during scale-up
  • Explore supplier process monitoring capabilities throughout the scale-up process
David Kolwyck, M.S., M.B.A., Principal Scientist, Amgen

Cells as Raw Materials

2:30
Regulatory Considerations Behind the FDA Guidelines on Cell Banking
Arifa Khan, Senior Investigator, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (invited)

3:00
Networking Refreshment Break

3:30
New Data
Platform for Standard Cell Banks and Development of High-Density Cell Banks
  • Discuss a platform approach for production of standard-density cell banks
  • Learn about banking process characterization for robust banking processes
  • Hear about the development of a high-density cell banking process
Mayur Jain, M.S., Process Engineer III, Cell Banking Development, Genzyme

Panel Discussion:

4:00
How to Ensure Cell Safety and Stability
Panelists: Speakers from earlier sessions

5:00
Close of Symposium

BDP Week
Vaccine Development & Production Summit

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