Upstream Technologies
A.
Advances in Biocatalysis
Biocatalyis is increasingly becoming a more prevalent and important technology. Enzymes offer
unique advantages over traditional catalysts (high specificity, high selectivity, low environmental
impact, etc.) and are also becoming more economically viable. Additionally, researchers are
minimizing the challenges that enzymes present (minimal range of pH and temperature, low
stability, etc.) through advances in genomics, proteomics, directed evolution, and rational design.
Biocatalysts are important to industrial applications such as the production of specialty
chemicals, polymers, and chiral intermediates. They are also vital to medical diagnostics and
drug discovery, particularly with the increasing development of high-throughput screening
assays. This session will focus on both theoretical as well as experimental achievements in
biocatalysis research and applications. We encourage presentations that discuss recent successes
in the optimization/engineering of biocatalysts and biocatalytic processes, and where the
potential impact to industrial or medical applications is novel and significant.
Co-Chairs: Huimin Zhao, U Illinois Urbana-Champaign, (217) 333-2631, zhao5@uiuc.edu and
Angela Lewandowski, Genzyme, (508) 271-2975, angela.lewandowski@genzyme.com
B.
Advances in Microbial Fermentation Process Development
The demand for fermentation products has increased in the past few years leading to an urgent
requirement for industry and academia to focus on increases in production capacity and the
improvement of existing yields for bio-processes. With huge investments involved in expanding
production capacity, industries have to rely primarily on process improvements for net
productivity gains. With current advances in molecular biology leading to a better understanding
of cellular mechanisms and cutting edge technologies to optimize upstream processes, the
biotech world has shown significant progress in bridging the gap between increasing demands
and limited production capacity. This session focuses on the methods used to improve
fermentation yields through strain engineering, novel methodologies and cutting edge technology
for fermentation process optimization. This session will include topics related to advances in
upstream process optimization, yield improvements through bioreactor design, processmonitoring and control techniques.
Co-Chairs: Mariajose Castellanos, UMBC, (410) 455-8151, mariaca@umbc.edu and Swapnil
Bhargava, Amgen, (805) 447-6241, swapnilb@amgen.com
C.
Advances in Metabolic Engineering
Metabolic Engineering includes the analysis and modification of metabolic pathways to optimize
genetic and regulatory processes within cells to increase production of certain substances.
Metabolic engineers commonly work to reduce cellular energy use (i.e., the energetic cost of cell
reproduction or proliferation) and to reduce production of waste or undesirable by-products.
Metabolic Engineering typically involves the redirection of cellular activities by the
rearrangement of the enzymatic, transport, and regulatory functions of the cell through the use of
recombinant DNA and other techniques. Much of this effort has traditionally focused on
microbial organisms, but important advances are being made in cell cultures derived from plants,
insects, and animals.
This session will cover recent experimental and modeling advances in the field of prokaryotic
and eukaryotic metabolic engineering. Areas of possible interest include but are not limited to:
models and expression tools for optimizing metabolic flux; development of new host organisms;
tools for elucidation of functional needs; pathway development and/or optimization for novel
drug, energy, or material production; and the application of cutting edge technologies to
metabolic engineering and synthetic biology challenges.
Co-Chairs: Kristala Jones Prather, MIT, (617) 253-1950, kljp@mit.edu and Nimish G. Dalal,
Bristol-Myers Squibb, (315) 432-9561, nimish.dalal@bms.com
D.
Advances in Cell Culture Process Development
As the number and quantity of recombinant proteins in development and commercial production
has increased over the last few years, the demand on process development and manufacturing
facilities has increased as well. While some of this demand can be met by building new
infrastructures and facilities, a more efficient and less costly means of meeting these needs is by
designing higher productivity processes that are well characterized and robust. This session will
focus on recent developments in the field of cell culture process development and engineering
with emphasis on enhancing yield and improving robustness of the culture process (i.e.,
excluding cell line manipulations). Topics include, but are not limited to, advances in clone
screening and development, bioprocess optimization, bioreactor design and operation, novel
control approaches, scale up/scale down methods, utilization of new technology and process
analytical techniques for cell culture.
Co-Chairs: Sarah Harcum, Clemson, (864) 656-6865, harcum@clemson.edu and Jayanth
Sridhar, Merck, (215) 652-0338, jayanth_sridhar2@merck.com
E.
Molecular and Cellular Approaches in Cell Culture Systems
Recent years have seen significant advances in molecular biology techniques as well as genomic
tools. Advances in vector systems, especially with the integration of genetic elements to
expression cassettes, have led to improvement in protein expression as well as streamlining of
the process of cell line development and optimization. Tools such as microarray and proteomics
are currently reaching a level of understanding and sophistication that they are starting to be
applied directly to further our understanding of cell culture based expression systems both in a
fundamental manner as well as to understand specific phenotypes and genotypes. Tools such as
siRNA are allowing for results derived from microarray and genomics to be applied to
engineering of cell culture systems to rapidly to test for functional validation of microarray and
proteomics data. These tools are also being applied to understand the metabolism of cell culture
systems as well as in the creation of designer cell culture systems, via significant host
engineering. This session is intended to focus on application of recent advances in molecular
and cell biology tools to further our understanding of both microbial and mammalian cell culture
systems. Examples on host engineering are also invited for presentation. Particular
consideration will also be given to papers that focus on application of cutting edge molecular
tools to improve the properties of the proteins expressed using cell culture systems.
Co-Chairs: Eric Shusta,Wisconsin, (608) 262-1092, shusta@engr.wisc.edu and Raghavan
Venkat, MedImmune, (301) 398-5817, VenkatR@MedImmune.com
F.
Applications of Systems Biology to Upstream Process Development
Systems biology is a newly emerging discipline that combines traditional Chemical and
Biochemical Engineering principles with systems-theoretic approaches and rapidly advancing
analytical capabilities. A key component of Systems Biology is the integrated characterization of
biological systems on organism-wide scales. Central to this integrated approach is (i) the ability
to rapidly gather quantitative system-wide data on different length and time scales and (ii) the
integration of large tracks of data into a coherent picture of the biological process.
The goal of this session is to explore the methods and technologies underlying Systems Biology
and their application to process development and improvement. Experimental and theoretical
papers are encouraged, with the ideal paper incorporating both. Areas of possible interest
include but are not limited to: models and expression tools for optimizing metabolic flux,
development of new host organisms for metabolite or protein production, tools for elucidation of
the functional properties of networks and systems, and the development or improvement of
pathways for novel drug, energy, or material production in both prokaryotes and eukaryotes.
Co-Chairs: Jeffrey Varner, Cornell, (607) 255-4258, jdv27@cornell.edu and Ravi
Radhakrishnan, Penn, (215) 898-0487, rradhak@seas.upenn.edu
Downstream Technologies
Downstream Processing: Impact of Product Properties on the Design and Optimization of
Downstream Processes
Understanding how product properties drive design and optimization of downstream
processes (bioseparations and formulation) and how downstream processes influence
product properties are both critical issues for the biotech community. Therefore, this
session will focus on new molecular insights, design principles and practical optimization
considerations that reveal how downstream processes impact product properties and how
specific product properties can influence the design of such processes. Products of
interest to this session are proteins, peptides, vaccines, natural products and oligo- or
polynucleotides. Product properties of interest include proper folding and minimization
of aggregation, glycosylation and other post-translational modifications, pegylation and
minimization of oxidation, cross-linking, deamidation and product-related impurities,
such as truncated, extended and degraded biomolecules. Examples of topics well suited
for this session:
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Approaches that guide optimal selection of specific unit operations and order of
process steps to enhance product properties
Studies of how operating conditions of downstream processes (e.g., mixing
speeds, flow rates, temperature) influence product properties
Novel separations or novel modes of carrying out existing separations that
improve product properties and minimize impurities
Theoretical and experimental insights into how solution environment, surfaces
and other aspects of downstream processes impact the final properties of
biomolecules
Co-Chairs:
Peter M. Tessier, Department of Chemical & Biological Engineering, Rensselaer
Polytechnic Institute, 110 Eighth Street, Troy, New York 12180, (518) 276 2045,
tessier@rpi.edu.
Arne Staby, Project Planning & Management, Novo Nordisk A/S, Nybrovej 90, DK-2820
Gentofte, Denmark, +45 4443 9989, ast@novonordisk.com.
Scale-up/Scale-Down
There has been a drive in the bioprocessing industries for more expedient development using less
material at smaller scales, with the end goal of developing commercial processes at increasingly
larger scales. This session will focus on principles and issues regarding the scale up or scale
down of bioseparation unit operations. Papers on the scale up of various separation processes
(chromatography, membrane, precipitation, etc.) could focus on the effect of scale, the
operational adjustments needed to handle very large scales, or the use of disposable formats.
Papers demonstrating improvements in scale down models, for the purposes of process
validation, troubleshooting, or acceleration of development timelines, are also sought. This
would include papers describing the use of high throughput screening formats (e.g., 96-well
plate), particularly if theoretical and/or empirical connections between these screening formats
and actual process performance can be established.
Session Chairs
Doug Frey. University of Maryland Baltimore County , Phone : (410) 455-3418 , Email
:dfrey1@umbc.edu
Scott Tobler, Wyeth, Phone : (978) 247-1078, Email : stobler@wyeth.com
Downstream processing – Emerging technologies for Downstream Processing
New drivers in the biotechnology industry have created a need for powerful new technologies in
downstream processing. Included among these drivers are the development of high-yielding
expression systems, products with projected multi-ton demands, new expression hosts and
systems, novel therapeutic modalities and potential competition from generic biologics. The
result has been an interest in novel, game-changing downstream technologies, with the potential
to radically impact the protein production industry at a fundamental level. This session will
focus on the development and application of cutting edge technologies, with emphasis on their
impact in the changing world of bioprocess development. Topics of interest include, but are not
limited to: development of new purification and primary recovery methods, disposable largescale technologies, unconventional process configurations, purification challenges for new
therapeutic modalities. Submissions that combine theory and practice, or relate one to the other,
are particularly sought.
Co-chairs:
David Wood, Department of Chemical Engineering, Princeton University, Princeton, NJ 08544,
(609) 258-5721, dwood@princeton.edu
Sanchayita Ghose, Process Sciences, Bristol-Myers Squibb, Syracuse, NY 13057, (315) 4317930, email: sanchayita.ghose@bms.com
Non-Chromatographic Separations: Innovations and Advances
The increasing demand for lower-cost/higher-throughput recovery processes in the
biotechnology industry has pushed our current process designs to the limits of their capability.
The low cost and high throughput nature of non-chromatographic techniques provides an
attractive avenue towards process intensification.
Non-chromatographic separation techniques have long been the workhorse of non-therapeutic
large scale purification processes, while chromatography remains the workhorse of current
biotherapeutic recovery processes. The challenge becomes tailoring these non-chromatographic
techniques to a GMP environment for process consistency, impurity clearance as well as process
“portability” to different manufacturing sites. Due to the strict requirements of therapeutic
processes in terms of process impurity clearance and product quality attributes, new cutting-edge
technologies may also be required to advance us beyond the landscape of our current
chromatographic paradigms.
This session is intended to examine key advances in established separation processes such as
centrifugation, depth filtration, membrane filtration, precipitation, crystallization, refolding, viral
filtration and ultrafiltration, as well as provide a venue for novel separation technologies. We
welcome presentations illustrating challenges and solutions to implementing these and other nonchromatographic techniques in processing of biotherapeutics and other biotechnology products.
Presentations exploring methods of high-throughput screening of non-chromatographic
separation methods are also encouraged.
Session Chairs
Chris Roberts , University of Delaware : Phone : 302-831-0838, email : cjr@udel.edu
Tony Cano, Genentech : Phone : 650-467-1422, email : tcano@gene.com
Bioprocess Integration: Case studies
This session will cover case studies that highlight a more holistic approach to bioprocess
development, optimization, implementation and change. The bioprocess could be at any scale
ranging from lab to pilot to manufacturing. As an example, papers detailing how upstream
bioprocess operations and performance impact the performance of downstream steps post harvest
(isolation and purification steps further downstream) will be accepted.
Of particular interest would be the impact of a new technology – examples include a new
bioprocessing step employed upstream, an in-line analytical tool (PAT) or off-line analytical
tool. The session will focus on lessons learned during the implementation of the new technology
or process change, regardless of whether the result was successful.
Session Chairs
Yuefeng Lu, Amgen, Phone : (805) 447-4897, Email : yuefengl@amgen.com
William Kelly, Villanova University : Phone :(610) 519-4947, Email :
william.j.kelly@villanova.edu
Downstream Process Modeling
Time-to-market pressure manifests directly in time-to-process pressure. Rapid development,
scale-up, and validation of downstream purification processes with fewer resources is the norm.
As a result of these development constraints, the amount of experimental data available to define,
develop and characterize a downstream process can be limited. Process modeling can be used as
an effective tool to aid in the development of biotechnology products, while cutting down on
development time, resource requirements, and experimental data required. Downstream process
modeling has been used as a predictive tool to streamline experimental work in several areas,
including chromatographic separation and unit operation scale-up predictions. Additionally, it
can be used to troubleshoot manufacturing deviations or used to gain further insight into complex
separation phenomena. This session will focus on recent advances in process modeling, in
particular those that use the latest technologies in modeling applications to speed up and/or
improve downstream process development and process scale-up.
Topics of interest include both novel macroscopic modeling (such the integration of unit
operations), as well as new microscopic modeling approaches that connect the behavior of
biologics with process design and operation variables (such as interaction of proteins with
surfaces in chromatographic and filtration environments). Contributions that use the latest in
modeling technology are particularly sought in this session.
Session Chairs
Todd Przybycien, Carnegie Mellon University, Phone : (412) 268-3857, Email :
todd@andrew.cmu.edu
Justin McCue, BiogenIdec, Phone: (617) 679-3500, Email : justin.mccue@biogenidec.com
Emerging Technologies
Nanobiotechnology session
The Nanobiotechnology Session is currently soliciting oral contributions highlighting cuttingedge innovations at the intersection of nanoscience, engineering, medicine and biology.
Research areas of interest include nanobiological assemblies, nanobio detectors/sensors,
nanobiopatterning, nanotoxicology, nanobio structural modeling, miniaturized noninvasive
diagnostic methods, targeted nanodelivery systems for drugs/genes, nanomaterial-aided in vivo
imaging/sensing, single molecule manipulation, and other related topics.
Bioenergy session
Today’s world faces a constantly increasing energy demand, depleting petroleum resources, and
rising greenhouse emissions. This makes research and development on alternative energy
extremely important, and bioenergy holds great promise in this regard. This session will contain
contributions focusing on the use of biotechnological routes for energy production. Example
areas are the production of hydrogen, methane, (cellulosic) ethanol or higher alcohols, synthetic
petroleum, and electricity by microorganisms and enzyme systems. Papers focusing on both
upstream and downstream technologies for biofuel production are encouraged, e.g., bioenergy
plant development, lignocellulose pretreatment/fractionation, cellulase engineering and
cellulase/hemicellulase cocktails, strain development, enzymatic biofuel cells and microbial fuel
cells. This year’s program lays a particularly strong emphasis on cutting-edge technologies and
recent industrial progress, including but not restricted to those employing systems biology,
metabolic engineering, -omic technologies, and other interdisciplinary approaches.
Synthetic Biology session
Synthetic Biology is a new approach to engineering biology, with an emphasis of technologies to
write DNA. Recent advances make the automated synthesis of long DNA polymers routine and
precise. Foundational work, including the standardization of DNA-encoded parts and devices,
enables them to be combined to create programs to control cells. This session will cover recent
experimental and modeling advances in the design and construction of gene, protein and
metabolic parts and systems.