2013 Archived Content

Purification Stream

3rd Annual
Purifying Antibodies & Recombinant Proteins

Streamlining Processes

May 1-2, 2013

As demand increases, processes need to improve in order to produce large numbers of purified antibodies and recombinant proteins. Currently, between expression and purification, almost half of the product is lost. Purification processes need to be innovated to enhance recovery, while maintaining quality and ensuring proper folding.

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 Tuesday, April 30 from 4:15 - 5:30 PLENARY KEYNOTE PANEL 

Conventional vs. Non-Conventional Formats 

 Janice ReichertModerator: Janice Reichert, Ph.D., Editor-in-Chief, mAbs; Managing Director, Reichert Biotechnology Consulting LLC
With the explosion in the number of formats available, what are the potential benefits and risks to patients? This panel will discuss the realistic outlook and uncertainties with developing a diverse array of non-canonical antibodies in terms of immunogenicity, safety, competitive marketplace, commercial development, business strategies, regulatory approval, target validation and clinical development.



David Meininger David Meininger, Ph.D., MBA, Executive Director, Molecular Discovery, Merck


Tillman GerngrossTillman Gerngross, Ph.D., CEO and Co-Founder, Adimab LLC; Professor, Bioengineering, Thayer School of Engineering, Dartmouth College


Trudi VeldmanTrudi Veldman, Ph.D., Senior Director, Biologics Generation, AbbVie




7:00 am Conference Registration and Morning Coffee

Process Development & Antibody Purification 

8:30 Chairperson's Opening Remarks

Todd M. Przybycien, Ph.D., Professor, Biomedical Engineering and Chemical Engineering, Carnegie Mellon University


How Purification Process Development is Meeting Today's Science and Business Challenges

Kristopher A. BarnthouseKristopher A. Barnthouse, Ph.D., Director, API Large Molecule Development, Pharmaceutical Development and Manufacturing Science, Janssen Pharmaceutical Companies of Johnson & Johnson

The biopharmaceutical industry is faced with incredible challenges.  Driven by pressures to reduce timelines and costs, R&D organizations are being asked to deliver more with fewer resources.   This talk will examine several ways that downstream process development is adapting to meet these challenges through advances in resins and membranes, use of process platforms, increased automation, and more efficient development design.

9:10 A Comparison of Protein A and Mixed-Mode Chromatography for the Purification of Monoclonal Antibodies

Stephen F. AndersonStephen F. Anderson, Ph.D., Director, Protein Chemistry, Sanofi Pasteur Vaccines

Protein A is the affinity matrix of choice for the purification of therapeutic antibodies, but there are instances in which an antibody can be damaged by the harsh elution conditions.  Mixed-mode chromatography can be used to gently purify delicate antibodies.  We compare both methods and show the advantages and disadvantages of each.

9:40 Targeting the Not-So-Well-Known Nucleotide Binding Site for Antibody Purification

Basar BilgiçerBasar Bilgiçer, Ph.D., Assistant Professor, Chemical & Biomolecular Engineering, University of Notre Dame

Typical processes for antibody purification are expensive and can have detrimental effects on the specific activity of the isolated antibodies.  We developed a method of small molecule affinity chromatography for purifying antibodies through a highly conserved domain in antibody Fab fragments.  This technique has an antibody capture efficiency of  >96%, with an antibody purity of  >93% while maintaining 100% antibody. 

10:10 Coffee Break in the Exhibit Hall with Poster Viewing

Improving Productivity 

11:10 Featured Presentation 

Continuous Chromatography (MCSGP) for the Purification of Therapeutic Proteins 

Massimo MorbidelliMassimo Morbidelli, Ph.D., Professor, Institute for Chemical and Bioengineering, Department of Chemistry and Applied Biosciences, ETH Zürich 

In this presentation, the concept of multicolumn continuous chromatographic processes (MCSGP) is outlined and the most recent advances in its development are discussed. An overview of the different continuous chromatographic processes currently available on the market is provided and their application to therapeutic protein purification is discussed. Various case studies are presented including bispecific MAbs as well as multi-fraction separations.

11:40 Capillary-Channeled Polymer (C-CP) Fibers: Structures and Chemistries for High-Throughput Protein Processing

R. Kenneth MarcusR. Kenneth Marcus, Ph.D., Professor, Chemistry, Clemson University

Capillary-channeled polymer (C-CP) fibers have been developed as separation platforms for downstream processing.  C-CP fiber columns are characterized by their high porosity, and can operate at high linear velocities without sacrifice to chromatographic quality.  In addition, the base chemistry of the fibers provides for a robust support while permitting great versatility towards surface modifications to affect high selectivity.  This combination of characteristics provides great opportunities to address this "bottleneck" in protein therapeutic manufacture.

12:10 pm Sponsored Presentation (Opportunity Available)

12:40 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

Improving Productivity 

2:00 Chairperson's Remarks
Basar Bilgiçer, Ph.D., Assistant Professor, Chemical & Biomolecular Engineering, University of Notre Dame

2:05 Microgels for Efficient Protein Purification

Boaz MizrahiBoaz Mizrahi, Ph.D., Research Fellow, Children’s Hospital Boston, and Postdoc, Massachusetts Institute of Techology

Microgel particles with pore structure and ligands distributed evenly throughout their matrices overcome the major limitations of protein purification systems: low ligand density on the immobilized matrix and protein access to those ligands. A straightforward synthetic scheme for a highly efficient microgel matrix is reported.

2:35 Scaling-Up of a Downstream Purification Process for a New Recombinant Product (Human-cl rhFVIII)

Martin LinhultMartin Linhult, Ph.D., Team Manager, Biopharmaceutical Development, Octapharma AB

Octapharma has developed a new process for the production of a recombinant human FVIII pharmaceutical product derived from a human cell line (HEK293F cells). Clinical trials are ongoing with positive results. During process development several different approaches have been tested, old established techniques as well as new ones have been evaluated. In this presentation, I will discuss scale-up of a new downstream purification process and also different purification alternatives that have been applied during the pre-clinical and clinical phase.

ForteBio logo 3:05 Speeding Bioprocess Decision-Making with Label-Free Protein Quantitation

Craig Tin, Senior Product Manager, ForteBio – A Division of Pall Life SciencesTraditional analysis techniques like ELISAs and blots may not always be the appropriate choice in the characterization of proteins and antibodies during production phases. The BLItz label-free system has been implemented for bioprocess monitoring to complement or replace existing test methods and speed decision making.

3:20 Sponsored Presentation (Opportunity Available)

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing

4:20 Problem Solving Breakout Discussions

Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in.

Continuous Chromatography

Moderator:  Massimo Morbidelli, Ph.D., Professor, Institute for Chemical and Bioengineering, Department of Chemistry and Applied Biosciences, ETH Zürich

• Different implementation of the Continuous Countercurrent Chromatography concept
• Pros and Cons with respect to Batch Chromatography
• When is it needed?

Protein Yield Loss Due to Precipitation in Automated Purification Systems

Moderator:  Maciej  Paluch, Research Associate, Protein Chemistry, Genentech

• How to more accurately detect precipitation in real-time scenarios.
• How to better prevent precipitate formation during low pH elutions (buffers, etc.)
• Is "rescuing" precipitated protein feasible?

Downstream Process Development

Moderator:  To be Announced

• Reducing time and cost.
• How technology is helping to overcome challenges.
• How to make Process Development more efficient.

Purification with Protein A

Moderator:  To be Announced

• Affinity.
• Improving selectivity.
• When is it worth the cost to use Protein A?

Affinity Tags

Moderator:  To be Announced

• How to select an affinity tag.
• His tags.
• Cleavage issues.

Blue Sky Bioservices5:20 Networking Reception in the Exhibit Hall with Poster Viewing

6:15 Poster Award

6:30 End of Day

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