Portfolio Bar

BioProcess International Conference & Exposition

BPI Is Engineered to Be Exactly What You Need It to Be…

Register Onsite

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


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., Principal Scientist, Continuous Processing, Pall Life Sciences

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.
Siddharth Parimal, Ph.D., Senior Engineer I, Biogen

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing
Multi-Column Chromatography (MCC) such as BioSMB has been proven to increase throughput and productivity of biopharmaceutical downstream processing. However, these improvements are limited at low product titers, which cause longer cycle times and thus lower productivity of the chromatography step. In this study we demonstrate the utility of Single-Pass Tangential Flow Filtration (SPTFF) in order to increase the concentration of product going to BioSMB. SPTFF-BioSMB was challenged with purifying MAb from clarified CHO supernatant using Protein A affinity sorbent. The SPTFF-BioSMB process was tested for both the feasibility of the concept and the robustness of the configuration. By placing the SPTFF device before the BioSMB step we demonstrated a multiple-fold productivity increase over traditional BioSMB and batch chromatography. Additionally, we found the method does not cause any significant changes in product quality even over a 20 hour period of continuous processing. A process economic study shows SPTFF-BiOSMB enables significant cost reduction to low titer processes. Thus, this technique could be readily applied to cell culture processes where product titers are lower than those for batch processes (e.g. perfusion cell culture).
Mark Schofield, Ph.D., Principal R&D Engineer, Applications R&D, Pall Life Sciences

Networking Refreshment Break

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.

Innovation at the Interfaces

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

Concurrent Technology Workshops

Continuous Processing at 2000L Single-Use Bioreactor Scale
Christel Fenge, Vice President of Marketing for Fermentation, Sartorius Stedim North America

Case Study
Optimized and Consistent Protein Glycosylation in Biosimilar Production
In the development of biosimilars, the biopharmaceutical industry is challenged with driving product quality toward equivalence with the innovative biotherapeutic. The consistent glycoform profile of biosimilars produced through large-scale cell culture is an important criterion that can dictate biological efficacy and ultimately regulatory approval. In addition, there is an increased interest in enhancing cell densities and product yields. This presentation will review advancements in glycosylation control in mammalian cell culture obtained through optimizing basal media, feeds, and process parameters. Case studies discussing recent optimization work utilizing the HyClone™ Metabolic Pathway Design process to, not only, improve product qualities, such as increased afucosylation or tri- and tetra-sialylated glycans, but also to increase cell density and enhance protein productivity, will be presented.
William G. Whitford, Sr. 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
James Brady, Ph.D., Vice President, Technical Applications & Customer Service, MaxCyte, Inc.

Mechanical Stress in Standard and Single-Use Pumps Using Cell- and Particle-Based Stress Analysis
The development of shear sensitive pumps is necessary to avoid cell or even product damage in the biopharmaceutical industry. In this study, the mechanical stress acting on cells, proteins and an emulsion were determined for commonly used pumps (e.g. peristaltic and diaphragm pumps) and compared to an alternative pump technology - the magnetically levitated centrifugal-pump (MagLev pump). For these investigations, the MagLev pumps caused lower mechanical stress on cells, proteins and emulsion drops compared to their counterparts.
Ina Dittler, MSc. Research Assistant, School of Life Sciences and Facility Management, Zurich University of Applied Sciences

Luncheon Presentations

The Future Journey from Molecule to Commercial Production
Perhaps the not so distance future of biodevelopment and production will have significantly reduced clinical development timelines, flexibility when utilizing single use technologies such as direct scalability, closed upstream processing, and continuous downstream options, as well as the ability to implement local production facilities on a global basis. The past decade has been one of rapid growth and change for single use technologies and they are establishing their identity within biopharma. And technology in general, the principle driver of globalization, has made the world larger in terms of access to emerging markets. This presentation will discuss the potential future state for processing using single use technologies as well as accelerated biodevelopment and deployment of these production facilities on a global basis.
Sue Walker, Provantage End-to-End Solutions, Merck Millipore

Integrate, Acquire, and Centralize In-Process Data from Roche Cedex Analyzers: Overview of Auto-Sampling Technologies from Flownamics and Bend Research and Data Management Solutions from Musa
Paul Strand, Application Engineer, Flownamics
Ali Yeyinmen, Product Manager, MUSA
Clint Pepper Ph.D., Bend Research

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

Featured Presentation

The Future of Cell Therapy
Anthony Davies, Ph.D., President, Dark Horse Consulting

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

Simplify and Intensify: Solutions for Cell Culture Process Intensification
Transformative cell culture technologies will be reviewed. The award winning ATF cell separation device enables process intensification and continuous processing, allowing for smaller bioreactors and smaller facilities in more locations. Media plays a key role in perfusion, the leading application for ATF, where addition of LONG®R3 IGF-I cell culture supplement boosts productivity significantly because it is 200 times more potent than insulin.
Millie A. Ullah, Ph.D., Associate Director, Product Management & Marketing, Repligen

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
During a manufacturing cell line development project in stable CHO-K1 cells, a significantly reduced specific activity of target protein was observed when compared to a reference standard. This case study highlights how the lack of activity was identified and how the development of an optimized cell culture process enabled identification of high productivity clones.
Oren E. Beske, Ph.D., COO, Aragen Bioscience, Inc

Case Study
Single-Use Fermentation: Understanding Process Economy and Process Performance
The entry of single-use bioprocessing and the benefits that come with disposables have generated interest in the microbial community. This talk will present results from a process economy comparison of fermentation scenarios based on stainless steel and single-use equipment. Additionally, data will be shown from a wet-work study of an E.coli domain antibody production using stainless steel and disposable equipment.
Kenneth Clapp, Senior Global Product Manager, Bioreactors, GE Healthcare

An Insight into Recent Developments in Protein A Chromatography
Protein A-based chromatography is the primary method used to purify MAbs. There has been a significant development of protein A chromatography media (resin), giving both higher capacity and improved stability to meet the changing requirements of the industry. More improvements are to come. We will provide some insights into the future plans of GE Healthcare's Life Sciences business for protein A media and our thoughts on what will be needed for the next generation of products.
Henrik R. Ihre, Ph.D., Director Custom Design Media, GE Healthcare Life Sciences

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

Case StudyNew Data
Introducing Amsphere A3: The Relationships and Considerations of Bead and Pore Structure, Surface Chemistries, and Ligand Design on Affinity Resin Performance
Industry needs, patent expirations of ligand design and market dynamics have accelerated the development and availability of many protein affinity resins. Technology providers must consider a range of design parameters such as resin backbone, bead size, pore size, surface chemistry modification, ligand construct and how they relate to performance criteria such as DBC, life time, caustic stability, and column packing among others. JSR's approach to designing Amsphere A3™ affinity resin will be discussed. The balance between resin design and resin performance will be illustrated through a case study.
Marty Siwak, Director, Separation Science Group, JSR Life Sciences
Zhuo Liu, Ph.D., Scientist, KBI Biopharma, Inc

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
  • 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 mkeenan@ibcusa.com.

Technology Workshop

Increasing Protein Production with Novel Cell Ess Supplement without Affecting Metabolic Profile
Enhancing protein production is a common bioproduction goal. At a concentration of 1% Cell Ess supplement resulted in a 37% increase in productivity. Used as a feed, it resulted in a 25% increase in yield and extension of peak protein production. Our results suggest than an increase in protein production may not require a change in the metabolic state of the cells.
Adam Elhofy, Ph.D., CSO, Essential Pharmaceuticals

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
Case Study
Protein unfolding on chromatographic surfaces has been known to occur on hydrophobic stationary phases, including reversed phase and hydrophobic interaction media. Recent work has, however, unearthed the occurrence of protein unfolding also on IEX matrices that were previously thought to be benign with regards to protein structure. The most dramatic macroscopic manifestation of protein unfolding on IEX surfaces is the appearance of multiple elution peaks as well the on-column formation of aggregates, both which have potentially deleterious effects on process performance. The occurrence of such phenomena in a range of chromatography matrices and for different monoclonal antibodies will be discussed.
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
Incorporation of multimodal resins at large-scale has steadily increased due to their ability to provide enhanced selectivity as compared to ion exchangers and hydrophobic interaction chromatography resins. Here we describe a high throughput method for identifying optimal operating conditions in terms of pH and salt concentration for multiple mixed mode resins in a single set of experiments using low material volumes. The insights gained from this work are then used to compare the selectivity of multimodal resins and resulting product yield to one another. Moreover, the assessment of multiple proteins enables the identification of the best mixed mode resin for a particular class of proteins.
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

Unlocking the Power of Analytics in Support of QbD in Process Development
In preparation for commercialization, Regeneron typically introduces a new high titer cell line and optimized production process. For this work, the principles of Quality by Design is leveraged for targeted, rational development. The presentation will provide examples of how analytical support is applied to serve a persistent focus on critical quality attributes to drive this development effort.
Hanne Bak, Ph.D., Senior Director, Purification Development, Regeneron Pharmaceuticals, Inc.

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.

Platform Evaluation of Cation Exchange Medias Downstream of Protein A Capture
In the development of downstream processes for monoclonal antibodies, the drive is for the most efficient process that produces high quality material with low process impurities. The work presented here targets a two-column monoclonal antibody purification process with decreased process complexity, increased process yields, and improved cycle times. By using a design of experimentation approach, lab-scale columns were used to evaluate numerous commercially available cation exchange medias. Overall, acceptable performance and productivity was observed for all medias investigated, however one media out performed in all categories.
Jennifer Earley, Research Scientist, Purification and Virology, Eli Lilly and Company

Technology Workshop

Delivering process and cost efficiencies for early clinical and biosimilars production with ProcessReady Columns
Time and cost pressure are significant for biosimilar producers or in early clinical phase production. The selection of highly productive, cost-effective resins for DSP is critical. The addition of ready-to-use formats to such a campaign can enhance process intensification and drive greater cost efficiencies. This workshop will present a platform process with ProcessReady™ columns from Purolite, pre-packed with Praesto™ affinity and ion-exchange resins.
Chris Major, MSc., Director of Agarose and Bioprocessing, Life Sciences, Purolite

Breakthrough Technologies for Establishing Biosimilar Target Product Profile Quality Attributes
Molly McGlaughlin, VP Business Development, EirGenix

Pall Biopharmaceuticals' Leader Details Significant Technology Advances Enabling Integrated Continuous BioProcessing
There is a lot of talk about Continuous Bioprocessing, but how does the desire for a continuous bioprocess get turned into reality? Pall Life Sciences is committed to building a working GMP end-to-end continuous bioprocess. The building blocks are in place, now hear how they are to be assembled into an integrated process.
Note: The presentation will be followed by a curated tour of the technologies at the Pall booth
Michael Egholm, Ph.D., V.P. and General Manager, Pall Biopharmaceuticals, Pall Biopharmaceutucals Division, Pall Corporation

Technology Workshops
Have Your Presentation Included Here! Contact Jennifer Wickett (companies A-L) at jwickett@ibcusa.com or Kristen Schott (companies M-Z) at kschott@ibcusa.com 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.
David Haas, Ph.D., Associate Director, Manufacturing Sciences and Technology Laboratory, 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