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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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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

Recovery & Purification Agenda

Recovery & Purification Agenda

Recovery & Purification

Capitalize on the innovation of methodologies, materials science and technologies to help optimize efficiencies, process design and flexibility in downstream processing for an emerging wave of antibodies and novel modalities.

  • Disruptive Harvest Step Technologies
  • Novel Chromatography Selectivities
  • Enabling Continuous Processing
  • Materials Science
  • High-Throughput Technologies
  • Advances in Modeling
  • Sequence Variant Analysis
  • Improving Flexibility and Facility Fit

Tuesday, October 21, 2014

7:00
Registration and Coffee

8:00
Chairperson's Opening Remarks
Uwe Gottschalk, Ph.D., Chief Technology Officer, Pharma Biotech, Lonza, Switzerland

Improving Flexibility through Process Design and Facility Fit

8:15
Case StudyNew Data
Decoupled Upstream and Downstream Operations to Improve Manufacturing Flexibility
Decoupling cell culture and purification processes offers a solution to accommodate increased product masses by adding flexibility to capacity and inventory management. A decoupling process was developed utilizing single-pass TFF and bulk-freezing technology to achieve a 20-fold reduction in centrate volume and create a stable frozen intermediate. A case study will be discussed to demonstrate potential benefits of decoupling.
Alex Brinkmann, Engineer II, Biopharmaceutical Development, Biogen Idec

8:45
Case StudyNew Data
Developing a Multi-Ton Antibody Production Process - Aggregate, Host Cell Protein and Facility Fit Challenges
A new high-producing cell culture process warranted development of a new late-stage clinical / commercial purification process for a challenging high-mass demand monoclonal antibody. The existing purification process with the new cell culture process resulted in higher levels of aggregate and host cell proteins. Resin screening was conducted with both high throughput robotics and column experiments to develop steps to reduce aggregate and host cell proteins. Ultimately, a process was developed that met all product quality, impurity removal and productivity goals while enabling facility fit.
Christopher Teske, Ph.D., Senior Engineer, Purification Development, Genentech, A Member of the Roche Group

9:15
Case StudyNew Data
Development and Process Characterization of a Precipitation Step using Sodium Caprylate for the Reduction of Host Cell Proteins
We describe the development and characterization of a precipitation step using sodium caprylate in the commercial manufacturing scale purification of a monoclonal antibody. Sodium caprylate has high solubility when added under neutral conditions but precipitates as the pH is lowered, resulting in the selective co-precipitation of acidic impurities such as host cell protein while antibodies with basic pIs remain in solution. The precipitate is then removed by depth filtration. During development, parameters such as sodium caprylate concentration and pH were optimized for host cell protein reduction, antibody product quality and recovery. Hold time to reach a stable precipitation level, agitation rate, filter grade and filtration flux were optimized for precipitate removal. Quality by Design principles were applied to gain further understanding of the interdependence of operational process parameters impacting process performance, and to characterize the robustness of the manufacturing design space. Data will be presented to illustrate the scalability of the precipitation step: approximately 100-fold reduction of host cell protein was robustly achieved over a wide range for all process parameters evaluated with acceptable product quality for all other attributes tested and recovery greater than 90 percent.
Jessica Prentice, Associate Scientist II, Purification Process Sciences, MedImmune

9:45
Networking Refreshment Break

Rapid, High-Throughput Process Development

10:15
New Data
High Throughput Platforms to Accelerate the Development of Particle Conditioning Steps for Vaccines
Flocculation and precipitation are used in production purification processes for many biologicals but suffer from limited small-scale models, which often leads to delays in translation to pilot scale and larger. We have developed an off-the-shelf, ultra scale-down system to evaluate rapidly particle conditioning using < 1 mL volume per condition. High throughput particle conditioning comprised of flocculation, aging, and solids removal can be screened with this technology and the results are scalable from the microplate up to Pilot- and production-scale.
Aaron Noyes, M.S., Process Engineer: Purification Process Development, Global Biologics, Pfizer Inc. and Department of Biochemical Engineering, University College London

10:45
Case StudyNew Data
High-Throughput Screening for Profiling of Non-Antibodies Using Disposable Technologies
Single-use technologies provide better economies and accelerate development timelines. Although a number of DSP approaches using this technology are heavily under consideration for process development, limited information is available on its use for candidate selection in late discovery-early development phase. For non-antibodies, developability parameters are poorly understood, and prediction of process performance based on these parameters is difficult. Case studies will be presented where traditional HTS purification approach is compared side-by-side with a disposable approach. In addition to rapidly assembling process, single-use technology helps to identify resource-intensive molecules and brings 'process research' to the area of early candidate development.
Amitabha Deb, Fellow, Integrated Biologics Profiling Group, Novartis Pharma

11:15
Case StudyNew Data
Development of Robust Wash Conditions for Protein A Capture Chromatography using High-Throughput Automation Technologies
Host Cell Protein (HCP), DNA and high molecular weight aggregate contaminant clearance is a significant challenge during downstream process development for biopharmaceuticals. We have employed high throughput automation technologies to screen a wide array of excipients at various pH ranges in combination with salt species to evaluate their effectiveness in removing impurities from the product pool during Protein-A capture chromatography.
Srinivas Chollangi, Ph.D., Scientist, Biologics Development, Bristol-Myers Squibb

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
A cell clarification process using acoustic wave separation (AWS) has demonstrated to be an attractive and beneficial alternative to depth filtration and centrifuge for the primary cell clarification step. CHO cell clarification efficiency using AWS is robust and consistent and show little to no effect on performance when subjected to changes in the properties of complex feed cell cultures with total cell densities up to 45E+06 cells/ml.
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
The need for removing cells and physical debris from cell culture media in preparation for purification is obvious, but there is a hidden barrier to downstream processing that it not. Recent publications have documented that chromatin ejected from dead cell nuclei interferes directly and dramatically with the ability of all purification methods to achieve their best performance. This barrier has been obscured for decades by the fact that chromatin detection and measurement requires harsh extraction conditions that do not occur within the body of assays normally used to characterize cell culture supernatants or purification performance. This presentation will give extensive new case study data from a Herceptin biosimilar, demonstrating the specific mechanisms by which chromatin interferes with protein A, cation exchange, anion exchange, and multimodal chromatography methods. It will further present proven methods for removing chromatin in advance of purification, discuss how they work, and show how they enable elimination of at least one fractionation step from antibody purification methods, including many process sequences that do not require protein A affinity chromatography.
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
Uwe Gottschalk, Ph.D., Chief Technology Officer, Pharma Biotech, Lonza, Switzerland

Innovation in Materials Science for Next Generation Purification

10:30
Case StudyNew Data
Innovating Integrated Process Development Through the 3M Emphaze™ Platform
Jon Hester, Senior Technical Specialist, 3M Purification Inc

11:00
Case StudyNew Data
New Single-Use Solutions for Harvesting High Density Mammalian Cell Cultures at Cubic Meter Scale
Here we describe an exhaustive experiment testing a new single-use harvest method of Sartorius Stedim Biotech based on diatomaceous earth as filter aid. A "worst case" CHO process showing cell concentrations > 25 x 106 and corresponding wet biomass of up to 8% was used to compare the new DBF application (at neutral and reduced pH conditions) against standard depth filter application and subsequently scaling-up the best performing method. Results were more than promising ensuring robust scalability and very high capacity and flow rate allowing for harvest of 2 cubic meter in less than 2 hours
Benjamin Minow, Ph.D., Director, Cell Culture Production Mid-Scale, Rentschler Biotechnologie GmbH, Germany

11:30
New Data
Advanced Hydrogel Membranes: Progress Towards Developing a Fully Integrated Single-Use-Per-Batch Platform for Flexible mAb Purification
The challenges of working with traditional chromatography columns and beads have been well documented as the bioprocess industry drives towards a more flexible manufacturing paradigm. A new single-use (per batch) chromatography platform promises to enable greater flexibility and economic effectiveness for downstream operations. In this presentation, the author will describe the mechanical and chemical composition of a new membrane chromatography technology that maintains high binding capacity and resolution at very high flow rates (residence time ≤ 10 seconds). Data will be shared that illustrate mAb purification performance for both capture (binding) and polish (binding and flow-through) purification modes using HD-C (weak cation exchange), HD-M (mixed mode), and HD-Q (strong anion exchange) membrane chemistries.
James Stout, Ph.D., Vice President, Process Sciences, Natrix Separations Inc.

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
We have implemented several strategies to streamline early process development for perfusion production of a therapeutic IgG that is being readied for transfer to the pilot plant for clinical material generation. These strategies include some perfusion-specific techniques in addition to many of the same tools and methods that are used for fed-batch process 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
Opportunities for applying new technologies integrated with continuous processing and enabled by single use will be discussed for monoclonal antibody production. This will include proof of concept examples for the integration of intensified upstream processing directly with automated continuous purification. The combined efficiencies gained by continuous processing, using integrated upstream and purification, will be compared by economic criteria to current manufacturing methods. The impact of the new approaches to smaller, multi product manufacturing facilities will be described.
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
Countercurrent Tangential Chromatography (CTC) is a new column-free continuous capture technology that enables fully disposable operation. Binding, washing, elution, stripping, and equilibration steps are conducted simultaneously on a moving slurry that is pumped continuously through a cascade of static mixers (e.g., to achieve binding equilibration) and hollow fiber membrane modules (to separate the fluid phase from resin particles). This talk will describe the model calculations that were used to optimize the productivity of a CTC system for monoclonal antibody purification using Protein A chemistry. The CTC process gave comparable antibody yield and host cell protein removal with nearly 10-fold greater productivity than that provided by conventional packed column chromatography. The system's design features bring additional degrees of freedom that allow the process developer to optimize productivity and reduce process costs by varying resin slurry concentration, flow rates, membrane conversion rates, and static mixer design based on the resin binding capacity and kinetics and any constraints on buffer usage.
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
To increase the throughput of downstream purification steps for hightiter antibodies (e.g. 10g/L+) , a technique for precipitating monoclonal antibodies in a continuous process with synergistic combination of polyethylene glycol and zinc chloride was developed. Several independent scaling factors and techniques for optimal precipitate isolation and removal will also be presented along with its integration into a downstream process.
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
ASAP process (Accelerated Seamless Antibody Purification) has been developed in BST Vitry department, enabling to run 3 chromatography steps in continuous mode with no holding time nor open phase. This means that a cell culture bulk containing the Monoclonal Antibody can be now fully processed through this continuous process to obtain a pure Monoclonal Antibody batch without human intervention, decreasing also resin and buffer costs. The process was updated recently, enabling to run with disposable technologies.
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
Carsten Voss, Ph.D., Application Specialist, Process Chromatography, Bio-Rad Laboratories, Germany

Novel Chromatography Selectivities

8:15
Case Study
Ligand and Matrix Engineering for Enhanced Protein Binding Capacity, Salt Tolerance, and Mass Transfer Kinetics in Multimodal Cation Exchange Chromatography
Giorgio Carta, Ph.D., Lawrence R. Quarles Professor, Department of Chemical Engineering, University of Virginia

8:45
Case Study
Affinity Purification for Improved Process Understanding and Decision-Making in Bioprocess Development for Enzymes
Venkat Ryakala, Process Engineer, Purification Development, Genzyme, A Sanofi Company

9:15
Case Study
Leveraging Selectivity for Purification of Novel Biotherapeutics
Xuemei He, Ph.D., Senior Staff Scientist, Process Chromatography Applications, Bio-Rad Laboratories

9:45
Networking Refreshment Break in Poster and Exhibit Hall

Purification Approaches and Platforms for Novel Modalities and Multi-Product Environments

10:30
New Data
Production and Purification of Bispecific Antibodies using DuoBody Technology
Rick Hibbert, Ph.D., Scientist, Assay & Bioanalytical Science, Genmab, The Netherlands

11:00
Case StudyNew Data
CaptureSelect™ Technology: Introducing One-Step Selectivity in the Purification of Biological Products
Affinity chromatography is one of the most effective methods for purifying protein therapeutics. The CaptureSelect™ ligand technology address protein purification challenges and provides a platform approach by introducing a highly selective capture step for primary recovery purification. Affinity resins have been developed specific for domains of immunoglobulins as well as for biotherapeutic molecules, biosimilars and viruses. These solutions offer unprecedented specificity to the target protein ensuring mild elution conditions for sensitive proteins at any scale and independent from the feedstock.
Frank Detmers, Ph.D., Director Ligand Application, Bioproduction, Thermo Fisher Scientific

11:30
Operational Excellence in a Multi-Product Environment
Thomas H. Oppolzer, Ph.D., Executive Director, Biopharmaceuticals, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

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

1:55
Chairperson's Opening Remarks

Improving Process Efficiency from Advances in Modeling

2:00
New Data
In Silico Modeling of Molecules to Create More Efficient Purification Processes
Steven Cramer, Ph.D., Professor of Polymer Engineering, Rensselaer Polytechnic Institute

2:30
New Data
Application of Mechanistic Modeling to Improve Process Understanding
Robert Todd, Ph.D., Director, Process Development, Amgen Inc.

3:00
Networking Refreshment Break

Characterization and Control of Variants and Impurities

3:30
Emerging Concepts in Process Characterization for Host Cell Proteins: Potential Impact on Biosimilars and Biotech Products
Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts

4:00
Case StudyNew Data
Sequence Variant Analysis and Control of a Recombinant Monoclonal Antibody Therapeutic
During generation of stable CHO cell lines, several cloning, amplification, and selection steps are conducted that could introduce a sequence variant. To improve cell culture consistency and cell productivity, the cell line for a recombinant monoclonal antibody (MAb) product was changed between Phase I/II and Phase III manufacturing. The new Phase III cell line was generated through de novo transfection. The amplified clone with highest titer was selected for subcloning due to its low level of sequence variant relative to other candidate clones. All four subclones produced were found to contain different sequence variants compared to the parent cell line, and at different levels. One of the subclones was chosen for the Phase III production because its sequence variant is distant from the CDR, and is not expected to have any impact on biological activity, glycosylation, hinge flexibility or structure. Because the sequence variant may impact PK or immunogenicity, Genentech requires that the levels of sequence variant in Phase III products have to be ≤1%. To control the sequence variant level, a method based on amino acid intrinsic fluorescence was developed and validated as a Quality Control release assay. This method can detect 0.1% sequence variant and has 0.2% quantitation limit. This presentation will talk about the analytical technologies used for the sequence variant characterization and correlation with cell age, method validation, control strategy, and FDA feedback on the comparability assessment.
Connie Lu, Ph.D., Senior Scientist, Global Method Management and Technology, Genentech, A Member of the Roche Group

4:30
Case Study
An Unexpected Chemical Modification of a Recombinant Monoclonal Antibody
Chris Chumsae, Ph.D., Senior Scientist II, Protein Analytics, AbbVie

5:00
Close of BPI 2014

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