BioProcess International Conference & Exposition

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Conference: October 26-29, 2015 * Exposition:  October 27-29, 2015 * John B Hynes Veterans Memorial Convention Center, Boston, MA


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

Conference: October 26-29, 2015 · Exhibition: October 17-19, 2015 · John B Hynes Veterans Memorial Convention Center · Boston, MA

Recovery & Purification

Recovery & Purification

Recovery & Purification

Building on the momentum being gained from the innovation of methodologies, materials science and technologies, companies will describe progress being made to optimize efficiencies, process design and flexibility in downstream processing for an emerging wave of antibodies and novel modalities.

Topics include:

  • Impact of new technologies on harvest step
  • Approaches to improve efficiencies and cost of goods while reduce timelines
  • Implementation of automated and high throughput process development
  • Utilizing clinical and commercial single-use systems in downstream processing
  • Advances in modeling and characterization to better predict, understand and control processes
  • Development and implementation of continuous downstream processes
  • Purification approaches and platforms for novel modalities
  • Impact on novel purification methods on downstream processing

Tuesday, October 27, 2015

Registration and Coffee

Chairperson's Remarks
Marc Bisschops, Ph.D., Scientific Director, Tarpon Biosystems

Implementation of Continuous Processing

Case StudyNew Data
Data Based Comparison of Capture and Polishing Steps in a Continuous mAb Process
Multiple capture and polishing resins were characterized and optimized for batch manufacturing. Selected resins were characterized using a two column continuous manufacturing system. Optimized batch and continuous processes were compared for productivity, impurity, and quality measures. Data were used to compare the two manufacturing methods and determine the feasibility of continuous downstream manufacturing from the perspective of small development organization.
John Schreffler, Ph.D., Group Leader, Purification Process Development, Eisai

Overcoming Downstream Bottlenecks in Downstream Processing
Improved manufacturing processes are being developed to improve manufacturing network productivity and enable process fit into existing plants. Several technologies were evaluated to address these bottlenecks and help productivity including (i) newer generation protein A resins with higher binding capacity (ii) a semi-continuous mode of chromatography (sequential multi-column chromatography) for antibody capture on protein A, and (iii) single pass tangential flow filtration coupled to purification steps to enable in-line concentration of intermediate product streams. This presentation will show how integration of these process improvements into the purification process can facilitate debottlenecking and improve facility fit.
Lynn Conley, Ph.D., Senior Principal Scientist, Biogen

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing
Mark Schofield, Ph.D., Principal R&D Engineer, Applications R&D, Pall Life Sciences

New Data
Operational Strategies and Buffer Design for Enabling Continuous/Straight Through Downstream Processing
Natraj Ram, Ph.D., Associate Director, Purification, Manufacturing Sciences, AbbVie Inc.

Networking Refreshment Break

Innovation at the Interfaces with R&D, The Harvest Step, and Formulations

Improved Methods for Assessing Developability of Monoclonal Antibody Candidates Prior to Purification
Peter Tessier, Ph.D., Associate Professor, Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute

Monoclonal Flocculation with Smart Polymer for Efficient Clarification of High Titer Cell and Improved Removal of Impurities
Ken Kang, Ph.D., Principal Scientist, Head of Purification R&R, BioProcess Sciences, Eli Lilly and Company

New Data
Media Development Towards High Cell Density, High Productivity, and Low Perfusion Rates for Continuous Biomanufacturing Platforms
The presentation will discuss our systematic approach for developing a cell culture media to support very high cell densities and high productivities while maintaining low perfusion rates for the integrated continuous biomanufacturing platform.
Yang Yang, Ph.D., Staff Scientist I, Commercial Cell Culture Development, Sanofi

Concurrent Technology Workshops

From Continuous Manufacturing Approaches for Single-Use Manufacturing
Christel Fenge, Vice President of Marketing for Fermentation, Sartorius Stedim North America

Optimal and Consistent Protein Glycosylation in Biosimilar Production
William G. Whitford, Senior Manager, Cell Culture, GE Healthcare

CQA Impurity Monitoring for Integrated Bioprocessing
This contribution proposes a novel approach using direct measurements of Critical Quality Attributes (CQA). We propose a CQA analyzer, which is based on a HPLC principle combined monolithic columns, which is used horizontally along the entire process, from upstream to downstream processing. Together with advanced multivariate data analysis algorithms, the chromatogram can be used as a fingerprinting method, allowing to track host cell impurities CQAs in a timely controlled way. Hence we present a PAT tool as per original definition.
Dr. Christoph Herwig, Professor of Biochemical Engineering, Vienna University of Technology, Austria

Rapid Production of Recombinant Proteins and Stable Cell Lines at Different Scales
Weili Wang, Ph.D., Principal Scientist, Protein Production, MaxCyte

Luncheon Presentations

Presentation TBA

Presentation TBA

Chairperson's Remarks
Abhinav A. Shukla, Ph.D., Vice President, Process Development & Manufacturing, KBI Biopharma, Inc.

Novel Approaches for Non-Chromatographic Purification of Proteins

Featured Presentation

Elastin-like Polyeptide Fusions for Purification and Delivery of Biologics
Ashutosh Chilkoti, Ph.D., Professor and Chair, Department of Biomedical Engineering, Duke University

Case StudyNew Data
A Universal Non-Affinity Purification Platform for Toxicity and Phase I Trials
This presentation will describe an approach to IgG purification that merges 3 growing trends in the industry. Pre-emptive removal of chromatin, which is known to interfere with all purification methods. Increasing reliance on flow-through chromatography, in this case describing a hybrid approach that increases productivity and purification performance. Polishing with a simulated-moving-bed (SMB) -based method that further increases productivity. Biosimilar case studies will illustrate all new data.
Pete Gagnon, M.S., Group Manager, Downstream Processing, Bioprocessing Technology Institute, Singapore

CMO Panel Discussion

Perspectives and Lesson Learned on Overcoming Challenges with Tech Transfers and Biomanufacturing
Moderator: Sid Advant, Ph.D., Business Unit Head, Biologics Division, Kemwell Biopharma
Panelists: Sandoz, Lonza, BI, Fujifilm Diosynth, KBI Biopharma

Short Break to Move to Keynote Session

Keynote Presentations

Chairperson's Remarks

David J. Pollard, Ph.D. Innovating mAb Production to Support the Immunotherapy Revolution
A new paradigm in cancer therapy is emerging with the recent success of the antibody mediated, immune tumor killing response for melanoma. Evaluations have expanded to include a range of tumor types. In addition new alternatives and combinations are aimed at improving patient non responsiveness to PD-1. These foundational efforts of emerging cancer treatment need to be supported by agile antibody supply solutions that meet the capacity demands, while improving global access and lowering costs. Technology solutions have been implemented to speed process development and shorten the critical time to first in human clinical studies. Innovative approaches towards the 'process of the future' will be shown that support flexible multi product lower cost manufacturing. Continuous processing enabled by single use provides an integrated solution and the implementation challenges will be discussed.
David J. Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co. Inc.

Spencer Fisk Innovative Process Development Strategies to Drive the Rapid Clinical Introduction of Emerging Biologics
The movement of a large portfolio, consisting of a broad spectrum of biological molecule-modalities, requires seamless integration from the research bench to the clinic. Deep alignment and partnership between the Research and the Process/Analytics functions allows for rapid and systematic product candidate screening, eliminating the most problematic candidates. Combining state-of-the-art cell lines with a regimented application of robust high-throughput process and analytical development packages enables record speeds to the first patient with minimal resources.
Spencer Fisk, Global Head, Biologics Process R&D, Novartis Pharma AG, Switzerland

Michael Anthony (Tony) Moody, M.D. Novel Approach to Developing and Producing Human Experimental Vaccines for HIV
Michael Anthony (Tony) Moody, M.D., Chief Medical Officer, Associate Professor of Pediatrics, Duke Human

Trick or Treat! Halloween Reception and Exposition Hall Grand Opening
The opening night reception sponsored by Roche will feature a Halloween theme complete with a fun and festive ambiance. Come and enjoy Halloween-inspired food, drinks, decorations and games while networking with exhibitors, poster presenters and other attendees in the exposition hall.

Wednesday, October 28, 2015

Registration and Coffee

Technology Workshop with Light Continental Breakfast

Presentation TBA

Chairperson's Remarks

Keynote Presentations

Kimball Hall Amgen's Next-Generation Biomanufacturing Facility
Described here is the establishment of a biomanufacturing platform for the production of biologic medicines. Competitive product portfolios that can respond quickly to changes in market dynamics have necessitated optimization of production strategies. The "Next-Generation Biomanufacturing" platform allows for fast and flexible drug operations for synthesis of drug substance in a reconfigurable manufacturing system. Key enabling technologies include modular construction, single-use bioreactors, disposable plastic containers, continuous purification processing and real-time quality analysis. Amgen's Next-Generation Biomanufacturing changes the way we will manufacture in the 21st Century.
Kimball Hall, Vice President Manufacturing, Amgen Singapore Manufacturing Pte. Ltd.

Konstantin Konstantinov, Ph.D. What is the Future of Continuous Processing - What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme

Networking Refreshment Break in Exposition Hall Sponsored by:

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

Improvements in Rapid, High-Throughput Process Development

Case StudyNew Data
The Use of a Scalable High-Throughput Method to Characterize and Optimize the PEGylation of a Recombinant E.coli Derived Enzyme
Development of a lysine PEGylation step was performed using high throughput methods to enable rapid screening of process parameters and identification of critical process parameters. This method using a statistical DOE approach was found to be accurate, repeatable, and scalable making it a useful development and characterization tool.
Christopher Miller, Senior Process Development Scientist, Downstream Process Development, KBI Biopharma

New Data
High Throughput Methods to Streamline Process Development and Improve Process Understanding
This presentation will highlight several areas of process development where our group has implemented high throughput chromatography screening techniques: 1) resin pipette tips to support upstream candidate selection, 2) early phase downstream development screening using resin slurry plates to map parameters and miniature columns to assess process robustness and 3) miniature columns for process characterization of late stage candidates.
John Welsh, Associate Principal Scientist, Process Development and Engineering, Merck & Co.

Case StudyNew Data
High Throughput Process Development to Accelerate Speed to the Clinic for Antibodies
Gregory A. Barker, Ph.D., Senior Engineer, Biologics Process Development, Bristol-Myers Squibb

Concurrent Technology Workshops

Case Study
Using Process and Activity to Drive Clone Selection
Oren E. Beske, Ph.D., COO, Aragen Bioscience, Inc

Single-Use Fermentation: Understanding Process Economy and Process Performance
Kenneth Clapp, Senior Global Product Manager, Bioreactors, GE Healthcare

An Insight into Recent Developments in Protein A Chromatography
Jonathan Royce, Senior Product Manager, Bioprocess Product Marketing - Downstream, GE Healthcare

Case StudyNew Data
Comparison of Methods and Materials for Single Use Bag Extractable Testing
This study highlights the relationship between two extractable test methods and the materials of construction of single use bag systems. The data show that the BioPhorum Operations Group (BPOG) protocol may not be sufficient as a single method for detecting extractables from single use bag systems, and that use of advanced materials like fluoropolymers allows more robust extractable detection methods.
Mike W. Johnson, Global Bioprocess Applications Manager for Life Sciences, Entegris, Inc

Presentation TBA
JSR Life Sciences

Networking Luncheon in the Exposition Hall

Chairperson's Remarks
Thomas C. Ransohoff, Vice President & Principal Consultant, BioProcess Technology Consultants, Inc.

Challenges and Impact of Emerging Modalities and Expression Systems on Downstream Processing

Case StudyNew Data
Demonstration of a Consistent and Robust Process for a Novel VLP-Peptide Conjugate Vaccine
Jennifer Thorn, Ph.D., Associate Research Fellow, Pfizer

Case StudyNew Data
Use of Mechanistic Modeling to Improve Process Understanding and Control of Polishing Chromatography Steps for Fc-Fusion Proteins
This work employs mechanistic chromatography modeling to gain improved understanding and control of column behaviors using fundamental adsorption and transport measurements. Cases will be presented to illustrate model-based evaluation of closely-related process parameters, as well as comparison between simulated and experimental results. Furthermore, in silico experimentation can facilitate efficient development and characterization of purification processes.
Xuankuo Xu, Ph.D., Senior Scientist, Biologics Process Development, Bristol-Myers Squibb

New Data
Downstream Processing Challenges Associated with the Purification of BMPs Expressed in Mammalian Systems
Bioventus LLC is developing an engineered BMP with enhanced receptor affinity optimized for increased efficacy in patients. The production of BMPs offers unique challenges not normally associated with conventional biologics such as antibodies. Challenges include the low solubility at physiological pH and a tendency to aggregate and precipitate requiring unusual conditions to stabilize the molecule throughout the production process. The presentation will focus on the development of processes to overcome production challenges unique to BMP family members.
Christopher T. Brown, M.S., Program Manager, Early Stage Protein Manufacturing, Bioventus LLC

Networking Refreshment Break in the Exposition Hall Sponsored by:

Advances in Host Cell Protein Identification, Understanding and Clearance

Case StudyNew Data
Characterization of Host-Cell Proteins Using Mass Spectrometry Enables Effective Purification Optimization
Host-cell proteins (HCP) belong to in-process impurities of biopharmaceuticals and can pose challenges to development of an optimized downstream purification process. Identification and quantitation of HCPs using mass spectrometry-based workflow enhanced the understanding of HCPs in terms of their physical properties and potential interaction with the biopharmaceutical proteins, which provide valuable information for optimization of purification process.
Lin Zang, Ph.D., Senior Scientist, Analytical Development, Biogen

New Data
A Novel Approach to Monitor Clearance of Host Cell Proteins Associated with Monoclonal Antibodies
Min Zhu, Ph.D., Senior Scientist/Purification Process Sciences, MedImmune LLC

Identification of Individual Host Cell Proteins with Mass Spec - Top Down and Bottom Up Approaches
Paul Brown, Ph.D., Scientist, Pfizer Inc.

Casino Night Networking Reception in the Exposition Hall
Feeling lucky? Wednesday night's Networking Reception in the Exposition Hall will feature a Casino Night theme where attendees can try their luck at classic casino games like Blackjack, the Big Six Wheel, and Poker. Co-Sponsored by: and

Thursday, October 29, 2015


Bioprocess "Problem-Solving" Discussion Topics and Moderators

These moderated discussions on a variety of bioprocess topics will allow you to share strategies and brainstorm solutions in an informal, small group setting.
  • QbD for Analytical Methods: Sharing Experiences and Approaches
    Kazumi Kobayashi, Ph.D., Senior Principal Scientist, Technical Development, Biogen
  • Single-use and Disposable Technologies in Bioprocess Development
    Wallace Lauzon, Ph.D., Senior Evaluator, Cytokines Division, CERB, BGTD, Health Canada
  • Regulatory Perspectives on Aging Facilities
    Nancy Green, Ph.D., Chief, Hormones and Enzymes Division, CERB, BGTD, Health Canada
  • Inspection Trends Summary
    Jeffrey Skene, Chief, Monoclonal Antibodies Division, CERB, BGTD, Health Canada
  • Regulatory Perspectives on CMC Submissions
    Health Canada Regulator TBA
  • Particulate Defects - Critical versus Minor
    Kevin Kerls, Inspection MSAT, Hillsboro Technical Operations, Genentech, Inc. - A Member of the Roche Group
  • Opportunities and Challenges of High Concentration Biologics
    Mark Moody, Ph.D., Chief Scientific Advisor, ReForm Biologics
  • Developability and Development: Improving the Outcome
    Valentyn Antochshuk, Ph.D., Principal Scientist, Group Leader, Formulation Design and Process Compatibility, Merck & Co.
  • Container Closure Integrity Testing and Technology
    Kevin M. Maloney, Ph.D., Principal Scientist, Technical Development, Biogen
  • Raw Materials Management in Biologics Production
    Dave Kolwyck, Director, Manufacturing Sciences, Raw Material Global, Process Owner, Biogen
If you are interested in proposing or moderating a discussion topic in this breakfast session, please email at Michael Keenan

Chairperson's Remarks
Carsten Voss, Ph.D., Applications Specialist, Process Chromatography, Bio-Rad Laboratories GmbH, Germany

Novel Chromatography Selectivities and Innovation in Materials Science for Next Generation Purification

Antibody Unfolding/Aggregation on Macroporous and Polymer Grafted Cation Exchange Resins
Giorgio Carta, Ph.D., Lawrence R. Quarles Professor, Department of Chemical Engineering, University of Virginia

A Comparison of Multimodal Chromatographic Resins: Protein Binding and Selectivity
Leslie Wolfe, Ph.D., Senior Scientist, Downstream Process Development, KBI Biopharma

New Data
Novel Approaches to Modulating Product Quality of Monoclonal Antibodies
Natraj Ram, Ph.D., Associate Director, Purification, Manufacturing Sciences, AbbVie Inc.

New Data
Separation of IgG Glycoforms and Subclasses Using Fc Gamma Receptors as Affinity Ligands
Austin Boesch, M.S., Co-Founder, Chief Executive Officer, Zepteon, Inc.

Networking Refreshment Break in the Exposition Hall Sponsored by:

Improving Yield, Purity, Control, and Product Quality Attributes in Downstream Processing

Wacker Biotech Refolding Technology - The Complement to ESETEC® Secretion Platform
Nicole Peuker, Ph.D., Scientific Specialist, Bio Process Development, Wacker Biotech GmbH, Germany

New Data
At-Line Process Analytical Technology (PAT) for Feed-Forward Control and More Efficient Scale Up of Biopharmaceutical Microfiltration Unit Operations
We present a novel approach to de-risk MF scale-up through the use of process analytical technology (PAT). Chromatography based PAT was employed to improve the consistency of an MF step that had been a bottleneck in the process used to manufacture a recombinant protein. A 10 minute reverse phase ultra high performance liquid chromatography (RP-UPLC) assay was developed to provide at-line monitoring of protein concentration. The method was successfully validated and method performance was comparable to previously validated methods. The PAT tool revealed areas of divergence from a mass balance based model, highlighting specific opportunities for process improvement. Adjustment of appropriate process controls led to improved operability and significantly increased yield, providing a unique example of successful PAT deployment in the downstream purification of a recombinant protein. The general approach presented here should be broadly applicable to reduce risk during scale-up of filtration processes and should be suitable for feed-forward and feed-back process control.
Douglas Watson, Ph.D., Senior Process Engineer, Merck Manufacturing Division, Merck & Co., Inc.

Case StudyNew Data
A Unique Approach to Limit Aggregates in Final Purified Products
Veronique Bailly, Ph.D., Principal Scientist, BioProcess Development CMC, Team Lead, BioProcess Development CMC, Biogen

Technology Workshops
Have Your Presentation Included Here! Contact Jennifer Wickett (companies A-L) at or Kristen Schott (companies M-Z) at for details

Networking Luncheon and Last Chance for Exposition Hall Viewing

Chairperson's Remarks
Sigma S. Mostafa, Ph.D., Director, Process Development, KBI Biopharma Inc.

Innovation at the Interface with Formulations

New Data
Impact of Ion-mAb Interactions on the UFDF Process: Towards Process and Product Design
Diane D. Dong, Ph.D., Principal Scientist, Manufacturing Sciences, AbbVie

Challenges of High Concentration Formulations - Dealing with Viscosity and Excipients
Pfizer Representative (Invited)

Networking Refreshment Break

Improving Process Performance in Clinical and Commercial Manufacturing

Case StudyNew Data
Hydrophobic Interaction Chromatography (HIC) Step Process Improvement in a Legacy Recombinant Human Enzyme Manufacturing Process
First generation legacy biologics manufacturing processes typically suffer from lack of thorough process characterization work and process understanding. The process improvement initiatives are further constrained due to the associated regulatory and validation impact of any process changes. In this work we present a case study of how the HIC capture step in a recombinant human enzyme (rhEnzyme) manufacturing process was improved and optimized within the bounds of the existing regulatory filings and process definitions. The process improvements led to substantially higher step yields, debottlenecking of the manufacturing process and improvement in overall processing efficiency. Understanding the impact of chromatography resin variability on process performance was key to the success of the process improvement project. The process knowledge was established via in-house data mining and analysis, lab-scale experimentation, manufacturing investigations and discussions with the resin vendor.
Rohit Ingale, Ph.D., Process Engineer III, Manufacturing Sciences and Technology (MSAT), Genzyme, a Sanofi Company

Downsizing Downstream Processing: A Novel Single-Use Purification Platform for Biologics
Upstream advancements have increased the volumetric productivity of cell culture processes thereby enabling the single-use upstream platform. Downstream operations remain dominated by column chromatography, a technology that has experienced relatively marginal increases in productivity, creating a mismatch with upstream technology. While traditional columns provide excellent chromatographic performance, the process productivity disadvantages inherent in this technology have created a roadblock to the overall modernization of biomanufacturing. A new platform of single-use (per batch) chromatography employs traditional, proven chromatography chemistries in a hydrogel membrane format that enables resin-like capacity with high speed flow characteristics typical of membranes. The combination of these performance attributes allows dramatically downsized and simplified process devices, which in turn, enables very simple, compact, flexible, yet robust downstream operations. This talk will describe capture and polish applications across a variety of modalities, including strong anion exchange and mixed-mode chemistries, and highlight some exceptional performance data, including expanded viral clearance.
James Stout, Ph.D., Vice President, Process Sciences, Natrix Separations, Inc.

Data Mining Full Scale Production Data for Continuous Process Validation
Brian Kearns, Ph.D., Principal Scientist, Technical Support, Manufacturing Sciences, Eli Lilly and Company

Close of Conference

Charles River
BPI China