Boston, MA

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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3M Purification, Inc

Pall Life Sciences

Roche Custom Biotech

Thermo Scientific - A Thermo Fisher Scientific Brand

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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

Manufacturing Strategy Agenda

Manufacturing Strategy Agenda

Manufacturing Strategy

Maximize efficiencies and cost savings across your manufacturing network through implementation of disruptive technologies, operational excellence and new facility concepts, while remaining flexible to the production needs of a diverse pipeline of novel molecules in a multi-product environment.

  • New Concepts in Biomanufacturing
  • BPOG Strategic Workstreams
  • Tech Transfer & Scale-up/Scale-down
  • Continuous Manufacturing
  • Single-use Applications & Town Hall Forum
  • Relaxing Environmental Controls in Facilities

Tuesday, October 21, 2014

7:00
Registration and Coffee

8:00
Chairperson's Opening Remarks
Ran Zheng, Executive Director, Plant Manager, Amgen

The Evolving Landscape of Biomanufacturing

8:15
Transforming Biopharmaceutical Manufacturing
Randy J. Maddux, Vice President and Site Director, GlaxoSmithKline

8:45
Biomanufacturing Strategies to Prepare for the Pipeline of the Future
Philippe-Alexandre Gilbert, Ph.D., Head of Upstream Development, Novartis Vaccines & Diagnostics, Inc.

9:15
Developing & Implementing Controls Supporting Fast-paced Multi-product (Phase 1 thru Commercial) Introduction into An Operating Commercial Manufacturing Facility
The presentation will focus on the process developed and refined to support rapid introduction of new products in various stages (Phase 1 thru Commercial) into an operating commercial manufacturing facility. CMOs face unique challenges when producing multiple products for multiple customers, some of these challenges include extremely rapid development to manufacture timelines including straight to GMP status for batch production. A flexible robust transfer process must be implemented to support various customer demands and the increasing industry pressure to execute at scale GMP batches without the execution of at scale engineering batches. The presentation will include lessons learned and improvements implemented during the development and rollout phases.
Bob Munday, Vice President, Technical Operations, CMC Biologics

9:45
Networking Refreshment Break

BPOG Strategic Workstreams: Progress and Industry Updates

10:15
Capacity, Technology and Innovation Trends in a High Variety Product Portfolio World
This presentation will discuss efforts to create industry roadmaps to align and guide accelerated development of game changing bioprocesses, as well as progress being made by manufacturers to meet challenging business needs for reduced unit cost, increased flexibility and robust compliance. New results from cross company deliberations will be presented, emphasizing stakeholder attention on critical process steps, as will progress on moving from concept to commercial reality more successfully and quickly.
Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom

BPOG Strategic Workstream Updates

10:45
Reflecting cGMP Requirements down the SUS Supply Chain
Tony White, Director, BioPhorum Operations Group (BPOG), United Kingdom

11:15
Continued Process Verification: A Model Plan Based on Cross-Industry Knowledge
Bert Frohlich, Ph.D., Director of Bioengineering, Shire

Concurrent Technology Workshops

11:50
New Paradigms in Bioproduction Culture Media Development
Biopharmaceutical production technologies, operations, and quality are undergoing a paradigm shift, resulting from the expiry of biologic patents, increased demand for personalized medicine, and increased global competition. This talk will review the impact of this paradigm shift on upstream production technology with a focus on optimization of cell culture media and feed formulations. In addition, the economics behind outsourcing and localized supply, for example, the relative value of powder versus bulk liquid supply and strategies based on improved shipping/packaging technologies, will be discussed. These advances in production technologies and shifts in operational strategies are driving a renewed focus on quality standards including analytic testing, formal risk analysis, and increased demands for purity, packaging, and cold chain.
William Whitford, Senior Manager - Hyclone Cell Culture, GE Healthcare Life Sciences

The Evolution of Laboratory Data Systems: Replacing Paper, Streamlining Process Execution, and Delivering Product and Process Insight
The laboratory has become an increasingly electronic environment. It's not just that the volume of data is greater than ever before, it's also being generated at ever-increasing speeds. As companies move towards a fully integrated lab environment there are benefits and pitfalls along the way. Successful projects start with a solid foundation, and keep a clear vision in mind.
Jarrod Medeirosc, Senior Consultant, IDBS

Luncheon Presentations (Open to All Attendees)

12:20
Integrated Single-Use Purification Technologies Enabling Continuous MAb Processing
Michael W. Phillips, Director, Technology Development, EMD Millipore

The LabChip GXII Touch: The Next Generation of High Throughput Biomolecule Characterization
Richard P. Bunch, Director, Microfluidics Product Portfolio, PerkinElmer

1:25
Chairperson's Opening Remarks
Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom

BPOG Strategic Workstreams: Progress and Industry Updates (continued)

1:30
Microbiological Monitoring for Biological Drug Substance Manufacturing - An Industry Perspective
David Bain, Ph.D., Facilitator, BioPhorum Operations Group (BPOG), United Kingdom

2:00
Raw Material Variability: The Need for Supply Chain Collaboration, Transparency and Mutually Beneficial Relationships
Albert Obrero, Senior Project Specialist, Bayer HealthCare

2:30
Panel Discussion
  • How can the industry improve risk control strategies more quickly in line with regulatory expectations?
  • Mapping the inbound material supply chain through multiple levels of interdependent suppliers
  • Achieving consistent understanding and application of new approaches that will be under regulatory scrutiny
  • How to rapidly ascertain industry best practice and implement successfully?
  • Do we need a new attitude to openness, cooperation and relationships?
Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom

3:00
Short Break to Move to Keynote Session

Keynote Presentations

3:10
Chairperson's Remarks
Guenter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, Biotechnologies R&D, GE Healthcare Life Sciences, Sweden

3:15
John G. Cox Delivering on a Global Biopharmaceutical Portfolio: Biogen Idec's Strategy for Success through Innovations in R&D, Protein Development and Manufacturing
John G. Cox, Executive Vice President, Pharmaceutical Operations & Technology, Biogen Idec

3:45
Robert Mattaliano, Ph.D. Keeping the Patient's and Caregiver's Experience in Mind
Robert Mattaliano, Ph.D., Group Vice President and Head of Biologics, Sanofi-Genzyme R&D Center

4:15
Geoffrey Ling, M.D., Ph.D. Biologically-derived Medicines on Demand for Battlefield Medicine
The current medical supply paradigm is non-responsive to far-forward emergency settings, emergent in-theater threats, and bio-preparedness stockpiling, often taking weeks to months to manufacture and airlift organic pharmaceuticals and protein therapeutics while not reaching the battlefield frontlines in time where it is needed most. A new manufacturing paradigm must be created to enable fast responses to specific threats without requiring specific threat preparedness, potentially eliminating the need to medically guess the enemy's intent, thus enhancing disaster responsiveness. DARPA's Biologically-derived Medicines on Demand (Bio-MOD) effort is focused on developing novel, flexible methodologies for genetic engineering and modification of microbial strains, mammalian cell lines and cell-free systems to synthesize multiple protein-based therapeutics in single-doses and short timeframes that meet purity, efficacy, and potency standards. Success in this effort will relieve the logistics burden and enable cost effective production of small quantity medications, particularly useful in the manufacture of orphan drugs.
Geoffrey Ling, M.D., Ph.D., Director, Biological Technologies Office, DARPA

4:45
International Food Festival and Grand Opening of the Poster & Exhibit Hall
Stamp your passport as you travel around the world in the exhibit & poster hall. You will enjoy sampling food and drinks from around the globe as you meet new contacts in this fun international themed reception. Plus, don't miss out on German beer and fare in booth #309 hosted by Roche. Cheers!

Wednesday, October 22, 2014

7:30
Coffee

Technology Workshop with Light Continental Breakfast

7:45
RepliGen Bioprocessing

8:30
Chairperson's Opening Remarks
John Hallinan, Chief Business Officer, MassBio

Keynote Presentations

8:45
Ganesh V. Kaundinya, Ph.D. Understanding Complexity in Biological Systems through Big Data Analytics- Applications to Biosimilars and Novel Biologics
Ganesh V. Kaundinya, Ph.D., Co-Founder and Chief Scientific Officer, Momenta Pharmaceuticals

9:15
Ralph Lambalot, Ph.D. Delivering Innovation in Biotherapeutic Manufacturing: From Continuous Improvement to Disruptive Innovation, What Can Current Industry Trends Tell Us About the Next 10 Years?
Ralph Lambalot, Ph.D., Vice President, Biologics Development, AbbVie

9:45
Networking Refreshment Break in Poster and Exhibit Hall

10:25
Chairperson's Remarks
Rick St. John, Ph.D., Senior Group Leader, Purification Development, Genentech, Inc.

Case Studies of Technology Transfer and Scale-up /Scale-down

10:30
New Data
Revamping a Technology Transfer Process to Maximize the Efficiency of a Multi-product Facility: Accommodating Transfer of Phase 1 Clinical to Commercial Processes
Pfizer's GMP biomanufacturing facility in Andover MA manufactures a wide range of therapeutic biologicals, from early Phase 1 clinical materials to late stage Phase 3 processes as well as approved commercial processes. To maximize the capacity of the facility the tech transfer process was revamped to enable it to effectively transfer the full spectrum of processes moving through the development pipeline and effectively transition between clinical and commercial processes. The revamping of the Tech transfer process also addressed the need to transfer processes faster to meet the need for more aggressive timelines and enhance collaboration and communication between the development and manufacturing organizations.
Jim McColgan, Director, Site Technical Services, Pfizer Global Supply

11:00
Case StudyNew Data
Overcoming Technical Challenges while Transferring a Bacterial Production Process into Manufacturing
A bacterial process was updated to increase manufacturing flexibility, ensure product supply, and improve operator safety. Upon transfer into manufacturing, however, a difference in bulk color was observed. The process was taken back to development for further understanding. The source of the color difference was identified and controls were implemented to prevent color formation. Identification of the colored adduct, implementation of process controls, and navigating a path to process approval will be discussed.
Rick St. John, Ph.D., Senior Group Leader, Purification Development, Genentech, Inc.

11:30
New Data
Challenges during Scale Down and Up of E.coli Processes
Scale down models are an essential element for process optimization, validation and troubleshooting. In this talk, key strategies and criteria in the development of E.coli scale down systems based on physical characterization will be discussed. Additionally, experienced challenges and pitfalls during scaling will be presented as case studies.
Britta Krampe, Ph.D., Process Engineering Manager, Roche, Germany

Concurrent Technology Workshops

12:05
Material Science & Cell Biology Approach to Guarantee Consistent Performance of New Flexsafe Bioprocessing Bags
Jessica Martin, Sartorius Stedim Biotech

Streamlining your Antibody to Antibody Drug Conjugate (ADC) Process
Lee Cheng (LC) Liu, CEO, EirGenix
Frank Ho, VP, Process Sciences, EirGenix

12:35
Networking Luncheon in Poster & Exhibit Hall

1:40
Chairperson's Remarks
Sadettin Ozturk, Ph.D., Head of Process and Analytical Development, MassBiologics

Continuous Processing for Manufacturing

1:45
Case StudyNew Data
Progress towards Efficient Implementation of Continuous Upstream Processes in Early Development
Daryl Powers, Ph.D., Senior Scientist, Early Cell Culture Development, Sanofi Global Biotherapeutics

2:15
Case StudyNew Data
mAbs for the Multitude by Automated Continuous Processing Enabled by Single Use
David Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co Inc.

2:45
New Data
Design and Optimization of Countercurrent Tangential Chromatography for Monoclonal Antibody Purification
Andrew Zydney, Professor and Department Head, Chemical Engineering, The Pennsylvania State University

3:15
Networking Refreshment Break in Poster and Exhibit Hall

Continuous Processing for Manufacturing (continued)

4:00
Case StudyNew Data
Using Continuous Precipitation for the Purification of High Titer Monoclonal Antibodies
Robert S. Gronke, Ph.D., Senior Principal Scientist, Biogen Idec

4:30
Continuous Chromatography, A Multi-Angle Solution to Drive mAb Capture Step Costs Down
Fabien Rousset, Ph.D., Deputy Director, Head of Biopharma Technologies, R&D, Novasep, France

5:00
Case StudyNew Data
ASAP: Toward a Fully Disposable Continuous Process
Benoit Mothes, Pharm.D., Senior Scientist, DSP Process Development, BioProcess Science and Technologies, Sanofi

5:30
Sports Night Spectacular in Poster & Exhibit Hall
Food, Networking & Fun! Wear your favorite team attire and stop by the exhibit & poster hall for an exhilarating night of networking. You can come early and stay late to enjoy all the your favorite sports night cuisine. Plus, show off your skills to win cool prizes with fun interactive sports games for all levels! Co-Sponsored by:
and

7:00
BioProcess International Dinner & Awards Ceremony

You will not want to miss the 'Industry Awards of the Year' celebration that recognizes and acknowledges the people, organizations and technologies that have significantly impacted, and advanced the efficiency of biotherapeutic development and manufacturing process ultimately allowing the industry to deliver better, more effective treatments to a global patient base.

Nomination Deadline: June 27, 2014 and can be entered online

Register to attend the dinner and ceremony during your registration for the conference or you can book a table by contacting Elizabeth Gormley at egormley@ibcusa.com

(Registration and fee required to attend)

Hosted and Organized by:

Thursday, October 23, 2014

7:00
Coffee

8:00
Chairperson's Opening Remarks
Millie Ullah, Ph.D., Senior Product Manager, Thermo Fisher Scientific

The Next Wave of Single Use Manufacturing: Closed Systems, New Technology and Cost Comparisons

8:05
Case StudyNew Data
Biomanufacturing Using Solely SU Technologies - Case Study and Cost Comparisons with a SS Facility
Single Use manufacturing is gaining considerable traction in the production of biopharmaceuticals. Biogen Idec has invested in a flexible manufacturing facility for drug substance production for clinical campaigns solely utilizing single-use technologies in controlled non-classified space. Multiple programs have been executed in this facility. In addition, cost models have been developed for this facility to enable a variety of comparisons and evaluations. In this Case Study, the various aspects (operational, regulatory, engineering, facility validation) of execution of a clinical program in this facility and the cost models developed for this program will be presented.
Venkatesh Natarajan, Ph.D., Senior Process Engineer III, Global Engineering Sciences, Biogen Idec

8:30
UNICAN: Dual Capability in Single Use Bioreactor
Disposable technology is being used more each year in the biotechnology industry. Disposable bioreactors allow one to avoid expenses associated with cleaning, assembly and operations, as well as equipment validation. However, one of the biggest challenges for single use technology including single use bioreactor is single sourcing of consumables. Typically, the consumables are tied to the hardware eliminating the flexibility and interchangeability among existing systems, which ultimately forces the end user to rely on a single vendor's supply chain. In order to address to this challenge, a 200L bottom mounted single-use bioreactor was converted into a universal can, or "Unican", which supports the use of both bottom mounted agitator and top mounted agitator single use bioreactors. The implementation of Unican increases flexibility for cell culture operations, improves assurance of supply, allows handling of any bag film changes/issues in future and increases the ability to negotiate pricing with bag suppliers. As part of the project, mass transfer and cell culture experiments were performed to ensure optimal performance of both bags in the Unican. Cell Culture data and mass transfer was shown to be comparable in both top and bottom mounted bags with historical data. Additionally, the modification of system was performed such that no hardware requalification was required post-modification. The system has been successfully implemented in pilot plant for bioprocessing.
Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech

8:55
Case Study
Disposables and Closed Systems Operation as Tools to Support the "Facility of the Future" Concept
The facility of the future concept with less segregation (ballroom concept) and parallel operation of several products at a time is currently being evaluated as alternative to the classical highly segregated GMP facility design for mAbs and other biologics. This talk will describe, how advances in closed processing in combination with disposables and continuous processing can support such manufacturing approaches including a detailed discussion about pro's and con's of such a set-up.
Berthold Boedeker, Chief Scientist, Bayer Healthcare AG, Germany

9:20
Single-Use Systems - Expanding Platforms
Daniel Nelson, Integrated Solutions Product Manager, Thermo Fisher Scientific

9:45
Networking Refreshment Break in Poster and Exhibit Hall

An Interactive Town Hall Forum

10:30
Standardization of Single-Use Systems: What is the Next Step for the Industry?
A meeting of the minds from BPSA, AS™, PDA, BPOG, ASME BPE, ELSIE, and USP
Town Hall Discussion Topics:
  • Where does the Single Use industry most need alignment of minimum requirements and or best practices?
    • What are your biggest SUT issues which could benefit from Alignment/Standardization?
    • What areas of SUT adoption/progress have been slowed/impeded due to lack of alignment/standardization?
  • Who should be responsible for what? How do we arrive at a consensus? How can we implement constructive change with so many different players vested in the outcomes?
  • What are the biggest issues related to particulates, E&L, change management & change control, risk management, system integrity, connectors and closed systems that must be addressed?
  • What is the next step for the industry?
Bring Your Ideas and Needs to the Table!
Add your questions and topics to the list above and join the conversation prior to the conference! Visit the BioProcessing Professionals group on Linked In at www.linkedin.com to cast your vote on the agenda of topics for this session, participate in voting polls and blogs and contribute to ongoing discussions regarding standardization of single-use systems and the implications for biologics developers and single use technology providers. Lend your voice to the discussions and help drive the biopharma industry to the next level of implementation. See page 16 for details.
Moderator:
James Dean Vogel, Founder and Director, The BioProcess Institute
Panelists:
ASME BPE Perspective: Jay Ankers, Director of Technology, M+W Group
AS™ Perspective: Robert Steininger, Senior Vice President, Manufacturing, Acceleron Pharmaceuticals, Inc.
BPOG Perspective: Tony White, Director, BioPhorum Operations Group (BPOG), United Kingdom
BPSA Perspective: Jerold Martin, Senior Vice President, Global Scientific Affairs, Pall Life Sciences
PDA Perspective: Bob Repetto, Senior Director, External Affairs, Pfizer
USP Perspective: Dennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corporation
ELSIE Perspective: Douglas J. Ball, Research Fellow, Pfizer

Concurrent Technology Workshops

12:05
Guidelines for the Selection of Chromatography Media (Resins) and Steps to Meet Specific Purification Challenges
Jonathan Royce, Senior Product Manager, Bioprocess Product Marketing - Downstream, GE Healthcare

12:35
Networking Luncheon and Last Chance for Poster & Exhibit Hall Viewing

1:55
Co-Chairpersons' Opening Remarks
Kristin Murray, Director, GCMC Regulatory Affairs, Pfizer
Stephen Reich, Director, Quality Systems & Compliance, Pfizer

Point-Counterpoint Session

2:00
Challenges and Considerations around Relaxing Environmental Controls in Biopharmaceutical Facilities
Agenda:
  • Introductory comments by session moderators
  • Industry goals and positions
  • Moderated participatory discussion
  • Regulatory goals and positions
  • Moderated participatory discussion
  • Panel Discussion: Envisioning the path forward - what does the future hold?
Moderators:
Kristin Murray, Director, GCMC Regulatory Affairs, Pfizer
Stephen Reich, Director, Quality Systems & Compliance, Pfizer

3:00
Networking Refreshment Break

Point-Counterpoint Session

3:30
Challenges and Considerations around Relaxing Environmental Controls in Biopharmaceutical Facilities (continued)
This session will feature provocative yet balanced discussion that will explore the conventional hypotheses surrounding the relaxation of environmental controls in biopharmaceutical facilities. A point-counterpoint format will explore both opportunities and caveats when correlating increasing process closure with decreasing environmental classifications and furthermore with decreasing facility controls. A panel of industry and regulatory experts will consider challenging questions such as: Does reducing area classification automatically equate to reducing facility controls? Should bioburden control be the primary driver for equipment closure requirements? Our diverse panel will attempt to achieve a balanced vision that progresses increasingly flexible biopharmaceutical manufacturing while maintaining product quality and patient safety.
Speakers and Panelists:
Jeffrey Skene, Acting Chief, Monoclonal Antibodies Division, Health Canada
Marc Pelletier, Ph.D., Director of Biotechnology, CRB Consulting Engineers
Joel Gates, Director of Quality Assurance, Shire
Alex Tschumakow, Director, Manufacturing, Shire
Anastasia Lolas, Owner & President, Visionary Pharma Consulting LLC
Paul L. Smock, Biotechnology Quality & Technical Consultant, Meridian BioGroup, LLC/BPOG
Speaker TBA, Pfizer

5:00
Close of BPI 2014

BDP Week

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