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 Sixth Annual
Protein Purification and Recovery
Streamlining Processes
January 13-14, 2014


This leading purification meeting explores how experts are innovating processes to achieve pure protein. The agenda includes process development and issues of scale, along with purifying challenging proteins, such as membrane proteins and kinases. Purifying antibodies is also addressed as is applying QbD concepts.  Continuous processing, crystallography and mass spectrometry are also discussed as technologies that aid processes and identify protein conditions.

Please join this in-depth discussion of purifying proteins and streamlining processes.


Day 1 | Day 2 | Download Production BrochureSpeaker Biographies 

SUNDAY, JANUARY 12

4:00-5:00 pm Short Course Registration

5:00-8:00 Dinner Short Courses (SC1-SC7) More Details >> 

4:00-8:00 Main Conference Registration

MONDAY, JANUARY 13

7:30 am Conference Registration and Morning Coffee


Process Development Towards Improvement 

9:00 Chairperson’s Opening Remarks

Jennifer Nemeth, Ph.D., Associate Scientific Director, Biologics Discovery Program Leader, Janssen R&D LLC

 

 

Keynote Presentation

YinYang S9:10 From Protein Purification to Vaccine Development – A Challenging but Rewarding Journey

Yan-ping Yang, Ph.D., Director, Downstream Purification, Bioprocess Research & Development, Sanofi Pasteur

The vaccine industry is fraught with high risk, long cycle times and requires approximately 12 years to bring a product from preclinical to licensure at a cost of $1 billion. Purification of protein antigens to achieve consistent product purity and quality is an integral part of the protein-based vaccine product development process. This presentation focuses on the challenges encountered by protein purification scientists and the rewarding experiences in the journey of vaccine development.


9:50 Insight in the Formation of DNA-Protein Precipitates During Downstream Processing and Implications for Process Development

André DumetzAndré Dumetz, Ph.D., Investigator, GlaxoSmithKline

Precipitate formation during downstream processing is a common problem that can undermine the scalability of a process. DNA-protein precipitates and coacervates, due to the carryover of small amount of DNA, often form in capture step eluates or during chromatographic cleaning steps. Several cases of study are presented and compared to the behavior observed on a DNA-protein model system to identify the main experimental trends. The implications for downstream process development and process robustness are discussed.

10:20 Coffee Break

10:45 Purification Strategies and Considerations in Overproduction, Isolation and Reconstitution of Labile Metalloproteins

Gareth ButlandGareth Butland, Ph.D., Staff Scientist, Lawrence Berkeley National Laboratory

Iron-sulfur (FeS) cluster cofactors are ancient cofactors, built for an anaerobic environment, yet are present in all kingdoms of life and essential for viability. FeS clusters can be damaged by molecular oxygen and reactive oxygen species depending on redox potential and solvent accessibility. The isolation of FeS cluster containing proteins in a biologically relevant and homogeneous form can therefore be challenging. I will present some of the strategies we utilize to produce and isolate FeS proteins in a bioactive form.

Ellen Brune S11:15 Bacterial Strains Based on the Separatome of Escherichia coli 

Ellen Brune, Ph.D., CSO, Boston Mountain Biotech

Improvement in throughput for recombinant biologic products can be realized by decreasing the amount of host cell proteins that interact with separation media as either binding proteins that reduce column capacity or eluting proteins that complicate gradient design. In an effort to streamline bioprocessing, our group has begun to rewrite the E. coli genome to substantially reduce the burden on purification steps, focusing on two popular bioseparation methods (Immobilized Metal Affinity Chromatography and Ion Exchange Chromatography).

11:45 Endotoxin Removal from Proteins Expressed in E. coli 

BarryHolwerdaBarry Holwerda, Ph.D., President, Molecular Throughput, Inc.

Preclinical evaluation of recombinant protein therapeutics requires the purification of proteins containing very low levels of endotoxin.  Proteins expressed in E. coli present a special challenge because of their source and often require methods that are specific to each protein.  This talk will summarize general principles and approaches to removing endotoxin highlighted by specific examples.

EMD Millipore12:15 pm Addressing Purification Challenges for Recombinant Proteins Expressed in Non-Mammalian Systems

Ryan_ShannonShannon Ryan, Ph.D., Process Development Scientist, EMD Millipore Corporation

The templated nature of MAb purification processes has simplified PD activities significantly. However, many new biotherapeutics continued to be developed in microbial expression systems. Process Development for these products can be an issue due to both challenging aspects of microbial expression and the fact that a template for purification does not exist. This talk will discuss key aspects of purification Process Development with for recombinant proteins expressed in microbial systems.

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


CONTINUOUS PROCESSING and TECHNOLOGIES THAT SUPPORT PROTEIN PURIFICATION 

2:00 Chairperson’s Remarks

Ellen Brune, Ph.D., CSO, Boston Mountain Biotech

2:05 Downstream Processing of Biologics Using Twin-Countercurrent Chromatography

Thomas Müller-Späth, Ph.D., CSO, ChromaCon AG

A novel twin-column, countercurrent sequential capture process (CaptureSMB) has been developed combining high-throughput with high capacity and allowing the optimal utilization of the stationary phase at reduced buffer consumption. For polishing steps, another twin-column chromatography process (MCSGP) is being used with the same twin column equipment. In this presentation, case studies for the purification of antibodies are presented using both processes. Column loading, productivity and buffer consumption will be discussed in comparison to single column batch chromatography.

2:35 IQGAP1 Protein Purification and X-Ray Crystallography

Vinodh KurellaVinodh Kurella, Ph.D., Research Fellow, Bioinformatics, Harvard Medical School

Protein purification process is a prelude to X-ray crystallography. A case study will be presented on IQGAP1, a scaffold protein overexpressed in colon cancer. IQGAP1 Calponin Homology domain was purified but precipitated before crystallization trials. Re-designing the construct lead to stabilization and also yielded high-quality crystals. However, in-house diffraction pattern revealed a fragile crystal. Finally, a synchrotron beam was utilized to solve the structure to 2.4 Å. Isothermal titration calorimetry was performed with substrate to reveal mode of interactions.

Jennifer Nemethy S3:05 Mass Spectrometric Applications for Assessing and Characterizing Biologics for Driving Development Success

Jennifer Nemeth, Ph.D., Associate Scientific Director, Biologics Discovery Program Leader, Janssen R&D LLC

There are a host of mass spectrometric applications that can be applied to the evaluation of a biologic for the purpose of assessing the therapeutics’ potential for success in development. These studies include purity evaluations, structure susceptibility assessments, stress assessments, and lot-to-lot comparability studies. This presentation will present an overview of useful assays / study designs, as well as case studies highlighting their use on therapeutics.

Forte Bio3:35 Versatile Use of Mixed-Mode Sorbents for Removal of Aggregates from Monoclonal Antibodies

Dasarathy_YamunaYamuna Dasarathy, Ph.D., MBA, Director, Marketing, Pall Life Sciences

Biopharmaceutical manufacturing requires high quality process development resulting in maximum degree of purity. Some biopharmaceuticals show a penchant for aggregating in solution the causes of which are still under investigation including high concentrations of target proteins as well as various stresses produced during downstream bioprocessing steps. Aggregation has been found to be a cause of immunogenicity and it reduces productivity of a process by impacting purity, recovery and yield. Additionally, host cell proteins that are inherent to all production processes can reduce efficacy. Mixed mode chromatography can be used to remove aggregates and other trace contaminants including host cell proteins and we will present a case study to elucidate the mixed mode mechanism. 

 

3:50 Refreshment Break


Purifying Antibodies 

4:15 Development of a Non-Protein A MAb Capture Step Based on Selective Precipitation Combined with CEX

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

A process was developed which uses selective precipitation combined with a novel cationic (CEX) resin as the initial purification step. Several CEX resins were evaluated for binding capacity, selectivity and cleanability. The selected CEX resin has a significant increased capacity over protein A and data indicate a purity which is nearly equal to a typical protein A eluate. The initial data show that the combined use of selective precipitation and CEX are promising for future “high” titer antibody purification processes.

4:45 Development of a Goat Polyclonal Antibody Purification Process for Improved Yield and Stability

Steven AllenSteven P. Allen, Ph.D., Manager, Biologics Process Design R&D, Diagnostics R&D, Abbott

A purification process for a goat polyclonal antibody has been redesigned to improve product quality and reduce production costs. A two-step purification process has been developed to improve low process yields due to high amounts of aggregate and precipitate.  Mabsorbent is used in the initial capture step in separating out the polyclonal IgG population followed by an immunoaffinity column that separates out the target specific molecule with high purity (>90%), high specificity (≥100%), and improved final yield.

5:15 A Novel Cell Culture Flocculation Process to Streamline Antibody Purification and Downstream Processing

Kenneth (Yun) Kang, Ph.D., Principal Scientist, BioProcess Sciences, ImClone Systems, a wholly-owned subsidiary of Eli Lilly & Company

Recent advances in mammalian cell culture processes have significantly improved product titers, but have also resulted in substantial increases in cell density and cellular debris, and often increases in process and product-related impurities.  In this study, we have developed a novel antibody harvest process that incorporates flocculation using a stimulus responsive polymer, benzylated poly(allylamine), followed by depth filtration. As tested on multiple antibodies, this process demonstrated high process yield, improved clearance of cells and cell debris, and efficient reduction of aggregates, host cell proteins (HCP) and DNA.  This novel and efficient process can be easily integrated into current mAb purification platforms, and may mitigate downstream processing challenges.

Protein Simple5:45-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing



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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  

 


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