January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics

Cambridge Healthtech Institute’s Third Annual
Higher-Throughput Protein Purification
Supporting Technologies
January 15-16, 2014


High-throughput processes have transformed the traditional protein-by-protein trial-and-error approach for testing criteria and scaling up. In this leading meeting, HTP will be investigated in the quest to develop methods that ensure quality and translate to large scale. Automation, robotics and liquid handlers are discussed, along with developing small-scale models that shed light on bioproduction. Case studies are presented that illustrate how leaders in the field are integrating HTP approaches in order to reduce the time and effort needed to successfully establish parameters.

Please join this in-depth discussion of HTP protein processing.


Day 1 | Day 2 | Download Production Brochure | Speaker Biographies 

TUESDAY, JANUARY 14

1:30-2:00 pm Conference Registration



BUZZ Sessions png

2:00 BuzZ Session A (More Details >>)

3:00 Refreshment Break in the Exhibit Hall with Poster Awards

3:45 BuzZ Session B (More Details >>)


4:30-5:00 Short Course Registration

5:00-8:00 Dinner Short Courses (SC8-SC14) More Details >> 


WEDNESDAY, JANUARY 15

7:30 am Conference Registration

8:00 Morning Coffee


INDUSTRIAL SCALE HIGH-THROUGHPUT PROCESSING 

8:15 Chairperson’s Opening Remarks

Ray Owens, Ph.D., NDM Senior Research Fellow, Division of Structural Biology, Oxford Protein Production Facility, University of Oxford


Keynote Presentation

Ian Hunt S8:20 High-Throughput Protein Expression & Drug Discovery – A Review

Ian Hunt, Ph.D., Group Leader, Protein Sciences, Novartis

A key ingredient to the successful identification and optimization of small-molecule compounds in drug discovery is the production of high quality recombinant proteins to help drive biochemical assays, biophysics and structural biology studies.
This presentation will therefore review some of the key strategies developed to expedite protein production to support these needs and in a timescale’s commensurate with modern drug discovery processes.  Topics covered will include the discussion of multi-parallel expression and purification strategies and the use of HT instrumentation for dealing with difficult to express proteins.  The presentation will also use a series of case studies from a number of different projects to illustrate the impact of the various approaches in the support of drug discovery campaigns.


9:00 Directed Evolution of Enzymes on an Industrial Scale

Andrew FosberryAndrew Fosberry, Ph.D., Manager, Expression & Fermentation Sciences, Biological Reagents and Assay Development, PTS, GlaxoSmithKline Research & Development Limited

Processes for the production of pharmaceutical drugs and their precursors can potentially be made more efficient by the application of biocatalysts. This can have a beneficial effect on the reduction in cost of goods, reduction in the carbon foot print associated with the manufacture and vastly improve the sustainability of the process. Directed evolution can be utilised to alter an enzymes substrate profile and thus improve the function of that enzyme for a new substrate or reaction condition. We will give an industry insight into how we have developing our processes to tackle this challenge.

9:30 Case Study: Tools for High-Throughput DSP Development

Guy de Roo, Ph.D., Project Leader, Downstream Processing, Biopharmaceuticals, Synthon

A workflow was developed that proved effective in obtaining robust and scalable purification processes. The approach first assesses the molecule’s preferred environment before the actual purification development takes place. A case study will be presented in which a CEX step was developed for purification of an antibody using structural modeling, buffer screening, filter plates and Atoll columns followed by scale-up to 20 cm columns.

10:00 Coffee Break in the Exhibit Hall With Poster Viewing


Htp Process Development 

Ron Gillespie S10:45 From Start to Finish, Applications of HTS to Accelerate Process Development

Ronald Gillespie, Ph.D., Scientist, Purification Process Development, Amgen, Inc.

Across the biotechnology industry, high-throughput screening (HTS) of chromatography resins for identifying optimal protein purification conditions has become an integral part of process development. In this talk, Amgen’s strategy for implementing high-throughput technologies for process development will be presented. Different HTS formats, such as micro-chromatography and batch binding in microtiter filter plates, will be compared for various applications such as candidate selection, process development and optimization. This talk will also emphasize Amgen’s efficiencies gained by data handling templates and close collaboration with our analytical teams to ensure decreased time from experimentation to data analysis.

11:15 Implementing a Buffer Optimization Screen into a High-Throughput Protein Production Core Service

William GilletteWilliam Gillette, Ph.D., Senior Scientist, Protein Expression Lab, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research

A core service protein production lab faces some unique problems in terms of buffer optimization. The huge diversity of targets and applications make it difficult to choose a one-size-fits-all approach. The talk will focus on the decisions we faced in choosing and implementing this platform with data from case studies presented to highlight the pros and cons of the approach.

11:45 A Multi-Platform Approach for High-Throughput Production of Secreted Proteins

Brandan Hillerich, Ph.D., Managing Director, High Throughput Protein Production, Albert Einstein College of Medicine

The Macromolecular Therapeutics Development Facility has developed and implemented a high-throughput pipeline for the production of secreted effector molecules. Through the use of robotics, the pipeline allows for rapid screening of protein expression in bacterial, insect and mammalian systems to determine what is best for scale-up production for structural and functional studies.

PerkinElmer NEW 200912:15 pm Application of Automated Purification Methods and Analysis for Process Development

Gerwe_BrianBrian Gerwe, Ph.D., Product Manager, PerkinElmer

LabChip® microfluidic technology enables the rapid analysis (<68sec/sample) of multiple protein characterizations including, molecular weight, titer, purity assessment, N-glycans profiling, and charge heterogeneity. The JANUS® BioTx Pro Workstation provides researchers with the ability to run batch binding experiments in filter plate, tip-based chromatography, and miniaturized chromatography column formats on a single system. Together these approaches eliminate bottlenecks in sample preparation and characterization resulting in shorter development cycles and increased efficiency. We will present purification optimization case studies demonstrating 10X reduction in time and sample consumption relative to traditional approaches (e.g. FPLC). The detailed evaluation of scalability and application of these small-scale optimization studies illustrate the increased productivity for development and characterization of biotherapeutics as opposed to traditional methods. 

 

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


Improving Processes 

2:00 Chairperson’s Remarks

Brian Gerwe, Ph.D., Product Manager, PerkinElmer

2:05 Membrane Ultrafiltration – Opportunities for Higher Throughput Processes

Junfen Ma, Ph.D., Principal Scientist, Amgen

Membrane ultrafiltration is used extensively in downstream processing, both for final formulation and for concentration and buffer exchange prior to other unit operations. This talk will examine new developments and understandings in ultrafiltration that provide opportunities for higher throughput processes. This talk will focus on the use of ultrafiltration to obtain highly concentrated monoclonal antibody products and the underlining mechanisms for existence of maximal protein concentration limitations.

2:35 High-Throughput Measurements of Protein Transport in Ion-Exchange

Abraham M. LenhoffAbraham M. Lenhoff, Ph.D., Chair & AP Colburn Professor, Chemical & Biomolecular Engineering Delaware Biotechnology Institute, University of Delaware

High-throughput measurements are increasingly used in process development for biologics, with the use of such approaches for chromatographic operations the focus of this presentation.  In this presentation the various formats routinely used for empirical assessment of separations performance will be reviewed, but the emphasis will be on the use of high-throughput methods for measuring fundamental chromatographic parameters and phenomena, such as adsorption isotherms and transport properties.  The integration of such high-efficiency methods with established modeling approaches offers an alternative pathway for high-throughput chromatographic optimization.

Andrew Stephen S3:05 High-Throughout Protein Characterization: Parallel Assessment of Thermal Stability and Aggregation

Andrew Stephen, Ph.D., Acting Director, Protein Chemistry Laboratory, Frederick National Laboratory for Cancer Research, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research

Understanding the thermal stability and aggregation properties of proteins is important for a myriad of applications. Measurement of the thermal stability of a protein can be determined using either extrinsic or intrinsic fluorescence. This presentation will focus on a parallel measurement of protein thermal stability and aggregation. Case studies will be presented where this approach has been applied to optimize buffer selection and characterize protein-ligand interactions.

3:35 Selected Poster Presentation
B602    Leverage High-Throughput Chromatography Tools for Vaccine Development

Sheng-Ching Wang, Senior Scientist, Vaccine Process Development, Merck & Co., Inc.

3:50 Refreshment Break


Automation 

4:15 Automation and Streamlining of Biopharmaceutical Purification Processes with High-Throughput Screening and Analytical Tools

Julia Spitz, Ph.D., Associate Director, Protein Science, Boehringer Ingelheim Pharma GmbH & Co. KG 

The Protein Science Department within Biopharmaceuticals at Boehringer Ingelheim GmbH & Co. KG utilizes a variety of high throughput analytical methods and screening tools to gain knowledge of the therapeutic protein as well as the purification process to shorten development timeline and streamline processes. To efficiently integrate these technologies, the Protein Science Department has developed the BI-PurEx Strategy. This strategy ensures a rapid, effective and flexible development timeline and an efficient process to meet the demands at any stage in product development, from clinical stage to market. This presentation will demonstrate how the integration of data from high-throughput biophysical assays and automated screening is used to develop critical process knowledge and a fast track to success.

Ray Owens S4:45 Development of a High-Throughput Pipeline for the Expression and Purification of Membrane Proteins

Ray Owens, Ph.D., NDM Senior Research Fellow, Division of Structural Biology, Oxford Protein Production Facility, University of Oxford

Nearly 30% of proteins in eukaryotic cells are known to be membrane proteins.  Efficient and reliable production of these proteins is critical for the drug discovery processes, HTP screening applications, structural biology and biochemical/biophysical analysis of the structure and function. Nevertheless, expression and purification of integral membrane proteins present significant technical challenges. Progress towards the development of a high throughput pipeline for the production of membrane proteins for structural studies will be presented. The extent to which lessons learnt from the production of soluble proteins will be discussed and illustrated by the results from recent projects.

5:15-6:30 Reception in the Exhibit Hall With Poster Viewing



Day 1 | Day 2 | Download Production Brochure | Speaker Biographies 

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      Premier Sponsors: 

EMD Millipore 

 Novozymes (white) 

PerkinElmer NEW 2009 

 Protein Simple  

  

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Training Seminars 

Mon-Tues, January 13-14 

Biologics Formulation and Delivery  

 


Buzz Sessions
BuzZ Sessions are facilitated, small-group discussions. Interactive participation leads to problem-solving solutions and future collaborations around focused topics.
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