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

Cell Culture & Upstream Processing Agenda

Cell Culture & Upstream Processing Agenda

Cell Culture & Upstream Processing

Build on recent achievements in reducing timelines and COGs while increasing efficiency and productivity through implementation of disruptive approaches and technologies across all stages of cell culture.

  • Genomic Tool Implementation
  • Synthetic Biology Applications
  • Implementing Continuous Processing
  • Commercial Single-Use Applications
  • Process Intensification
  • Raw Material Integrity Testing
  • Media Development and Optimization
  • Small Scale Models and Tech Transfers

Tuesday, October 21, 2014

7:00
Registration and Coffee

8:00
Chairperson's Opening Remarks
Charles Sardonini, Ph.D., Director, Process Engineering/Development, Genzyme, a Sanofi company

What's Next in Biologics Production

8:15
New Data
Raw Material Characterization and Risk Assessment - Impact of Trace Element Variability in Cell Culture Process Performance
Barry Drew, Ph.D., Senior Analytical R&D Scientist, SAFC

8:45
Case StudyNew Data
Screening Soy Hydrolysates for the production of a Recombinant Therapeutic Protein in Commercial Cell Line by Combined Approach of Near Infrared Spectroscopy and Chemometrics
The primary goal of this study was to develop a spectroscopy based chemometric method, a partial least squares PLS, to screen soy hydrolysates for better yield of protein production (titers) in cell culture medium. Harvest titer values of 29 soy hydrolysate lots with production yield between 490 mg/L and 1350 mg/L were obtained from shake-flask models or from manufacture engineering runs. The soy hydrolysate samples were measured by Near Infrared (NIR) in reflectance mode using an infrared fiber optic probe (IFOP). The fiber optic probe could easily enable in situ measurement of the soy hydrolysates for convenient raw material screening. The best PLS calibration has a determination coefficient of R2=0.887 utilizing no spectral preprocessing, the two spectral ranges of 10,000- 5376 cm-1 and 4980-4484 cm-1, and a rank of 6 factors. The cross validation of the model resulted in a determination coefficient of R2 = 0.741 between the predicted and actual titer values with an average standard deviation of 72 mg/L. The inter-operator and intra-opearator variances are within acceptable range and the method was transferred to the vendor’s quality lab. Compared with the resource demanding shake flask model, the combination of NIR and chemometric modeling provides a convenient method for soy hydrolysate screening with the advantage of fast speed, low cost and non-destructive.
Gary Li, Ph.D., MBA, Senior Scientist, Forensic Lab, Drug Product Development, Amgen Inc.

9:15
Development of Transient Expression System Based in CHO
Case StudyNew Data
We discuss the development of a PEI-mediated transient CHO-GS KO system capable of generating high yields, scalable up to 2L. This was achieved through rigorous optimization of cell density, DNA and PEI amounts followed by process development strategies. The newly developed method increased our average expression yield by ~4 fold relative to the existing transient HEK293 method.
Gavin Barnard, Ph.D., Senior Research Scientist, Biotechnology Discovery Research, Lilly Research Laboratories

9:45
Networking Refreshment Break

Improving Product Quality and Control

10:15
What Factors to Consider When Selecting an Analytical Method for Cell Culture Fermentation: Comparison of Cedex Bio HT, Nova Flex, and YSI 2950 CuBiAn Systems Technologies and Performance
Caitlin Kurtz, Biogen Idec and NC State

10:45
Understanding the Influence of Cell Culture Medium Composition and Process Parameters on Charge Variant Heterogeneity of Recombinant Antibodies
Charge heterogeneity of recombinant proteins has gained attention due to their potential influence on stability and biological activity. In this study, modulation of the distribution of acidic variants and C-terminal lysine variants using select medium additives (amino acids, vitamins, salts and trace elements) and process parameters will be presented. A summary of these strategies and an overview of the underlying mechanisms will be discussed.
Kartik Subramanian, Senior Scientist, Manufacturing Sciences, AbbVie Bioresearch Center

11:15
Case StudyNew Data
Monitoring Trace Metals Concentration during Cell Culture Process Development
Cell culture media components such as amino acids, vitamins, growth factors and trace metals are known to play critical role in controlling the process performance such as cell viability, cell density and specific cell productivity. Variability of media components including trace metal concentration associated with raw materials could influence product quality attributes. In this presentation, case studies of the importance of monitoring trace metal concentration during the various stages of cell culture process will be provided. These case studies include understanding the consumption rates of trace metals over the cell culture duration, observed loss during the filtration of the liquid media, variability of trace metals levels across raw material lots that help facilitate a robust manufacturing process.
Anil Raghani, Ph.D., Principal Scientist, Process & Product Development, Amgen Inc.

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
Thomas C. Ransohoff, Vice President & Senior Consultant, BioProcess Technology Consultants, Inc.

Innovation at the Interface of Upstream & Downstream Processing

1:30
Case StudyNew Data
Acoustic Wave Cell Clarification Technology: A Disruptive Technology for the Harvest Step
John Rozembersky, Vice President, BioPharm Separations, FloDesign Sonics

2:00
Practical Implementation Challenges for Introduction of a Disposable Depth Filtration System in a Multi-Use Manufacturing Facility
Mark Iverson, Principal Research Associate, BioProcess Development, Genentech, A Member of the Roche Group

2:30
Case StudyNew Data
Chromatin: The Invisible Interface between Upstream and Downstream Processing
Pete Gagnon, M.S., Head of Downstream Processing, Bioprocessing Technology Institute, Singapore

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
Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants, Inc.

Improving Efficiency, Productivity and Timelines in Cell Culture

10:30
Case StudyNew Data
Implementation of Frozen Seed Train Intermediate to Initiate CHO Cell Culture Manufacturing Campaigns Quickly and Efficiently
Jason Goodrick, M.S., Senior Engineer, Late Stage Cell Culture, Genentech, A Member of the Roche Group

11:00
New Data
Secretion Augmentation via Host Cell Engineering to Improve CHO Cell Productivity
Scott D. Estes, Ph.D., Director, Cell Culture Development, Biogen Idec

11:30
New Data
From Gene to Manufacturing: Application of Efficient Strategies During Development to Deliver Reliable, High Quality Biomanufacturing Processes
Alison Porter, Ph.D., Head of Mammalian Cell Culture R&D, Fujifilm Diosynth Biotechnologies

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

Case Study
Studies of Cell Culture Media effects on Therapeutic Protein Quality
Due to the impact structural configuration has upon the safety and efficacy of therapeutic proteins, Irvine Scientific developed and applied relevant assays, including functional cell-based assays and structural analyses of protein glycosylation, to achieve desired antibody protein glycosylation along with its effector activity during the course of cell culture media development and optimization.
Jessie H.T. Ni, Ph.D. M.O.T., Chief Scientific Officer, Irvine Scientific

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
Spencer K. Parkinson, Lead for Product Management Team, Product Management, 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
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

Late Stage Cell Culture

10:30
Case StudyNew Data
Cell Culture Small Scale Model Development for a Commercial Legacy Process
Using iterative design, a process was developed that generated a small-scale model of a commercial legacy process. Multiple process parameters were modified, including pH strategy, feeding strategy, base addition strategy, initial seeding density, gassing strategy, bioreactor geometry, and agitation. Product Quality was verified and the model can be tested with confidence that results obtained are representative of commercial scale product.
Hunter Malanson, Development Associate IV, Upstream Development, Alexion Pharmaceuticals

11:00
Case Study
Challenges and Lessons Learned During Scale Up and Tech Transfer of a Non-Platform NS0 Process
Mei Shao, Ph.D., Scientist II, MS&T, AstraZeneca

11:30
Case StudyNew Data
Six Month Tech Transfers: Process Fit and Scale Up for Manufacturing of Biologicals
T. Craig Seamans, Ph.D., Principal Scientist, BioProcess Development, Merck Research Labs

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
Chairperson's Opening Remarks

Impact of Raw Materials on Product Quality

2:00
Dual Sourcing Qualification of Complex Raw Materials
As regulatory agencies increase their knowledge of biopharmaceutical manufacturing and the variables which can impact performance, their sensitivity to changes in raw materials increases as well. This presentation will review technology developments in the industry which are evolving the definition of comparability of raw materials and how a risk based approach can be applied to assure the consistency of the manufacturing process.
Dave Kolwyck, M.S., MBA, Principal Scientist, Amgen

Interactive Panel Discussion:

2:30
How Well do You Know the Raw Materials Used in Your Upstream Manufacturing Process?
The panel will discuss what information from cell culture media suppliers is a "nice to have" vs "need to have" along with the challenges suppliers face in providing the level of information requested.

3:00
Networking Refreshment Break

High-Throughput, QbD and DOE Approaches to Process Development

3:30
Case StudyNew Data
Characterization of a CHO-Based Monoclonal Antibody Production Process Using Quality by Design
Genentech is using a QbD approach to Process Characterization and Validation. The experimental designs used employ the concept of statistical projectability. Results from recent PCPV studies will be shown.
Brian Horvath, Ph.D., Scientist and Technical Development Team Leader, Late Stage Cell Culture, Genentech, a Member of the Roche Group

4:00
Case StudyNew Data
Using High-Throughput Tools to Streamline Cell Line and Cell Culture Platforms to Accelerate Early Stage Process Development
Rashmi Kshirsagar, Ph.D., Associate Director, Cell Culture Development, Biogen Idec

4:30
Case StudyNew Data
Ambr48 as a Tool for Process Development and Key Process Parameter Identification for the Manufacture of a Biosimilar in CHO cells
Matthew Zustiak, Ph.D., Principal Scientist, Cell Culture Development, Gallus Biopharmaceuticals

5:00
Close of BPI 2014

BDP Week
Vaccine Development & Production Summit

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