The Bioprocessing Summit
2013 Archived Content

August 21-22, 2013

Cambridge Healthtech Institute’s Second Annual
High-Concentration Protein Formulations

Overcoming Challenges in Stability and Aggregation


Day 1 | Day 2 | Short Courses | Download Brochure 

Wednesday, August 21

7:45 am Registration & Morning Coffee


Formulation and Delivery Approaches for High-Concentrations Protein Formulations 

8:25 Chairperson’s Remarks

Dhananjay Jere, Ph.D., Group Leader, Early-Stage Pharmaceutical Development & GLP Supplies, Biologics Europe, F. Hoffmann-La Roche Ltd.


KEYNOTE PRESENTATIONS:

8:30 Challenges in Developing High-Concentration Protein Formulations

Donna LuisiDonna L. Luisi, Ph.D., Senior Principal Scientist, Pharmaceutical Research & Development, Pfizer, Inc. - Biography 

There are many challenges faced in the development of high protein concentration formulations. An important aspect of this is managing the viscosity behavior. My talk will focus on modulating the solution conditions by varying solution pH, ionic strength and excipient composition.

9:00 Optimizing the Colloidal Stability of Protein Formulations

Thomas Laue Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire  - Biography 

The colloidal stability of high-concentration protein formulations is central to preventing aggregation and avoiding high viscosities. The colloidal properties are electrostatic in origin, and may be manipulated by changing solvent conditions. This talk will focus on how to select solvent properties that will optimize colloidal stability.


9:30 A Three-Tiered Approach for the Development of a High Concentrated Protein Formulation

Thomas Pohl Thomas Pohl, Ph.D., Senior Scientist, Research & Development, SuppreMol GmbH - Biography 

Therapeutic proteins can be formulated at high strength either as a liquid, can be lyophilized and reconstituted or can be prepared as microcrystalline suspensions. These complementary approaches are exemplified for a relevant therapeutic protein - and pros and cons of each approach are discussed. Additionally the applicability of analytical tools for the characterization of high concentrated formulations is discussed.

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

10:45 High-Concentration Formulation Development of a Monoclonal Antibody: The Challenge of Converting a IV Formulation to a Sub-Q Formulation That is Both Stable and Easily Administered

Danny Chou Danny Chou, Ph.D., Senior Research Scientist, Biologics Development, Gilead Sciences, Inc. - Biography 

Development of high-concentration monoclonal antibody formulation is a significant challenge and often necessitates a thorough evaluation on a case-by-case basis. The purpose of this presentation is to share some insights from an effort to use the rational approach to evaluate a monoclonal antibody candidate with respect to both physical and chemical properties that may impact one’s ability to convert an IV formulation to a SC formulation that can be easily administered in a market-competitive configuration.

11:15 Enabling High-Concentration Protein Compositions

Jan JezekJan Jezek, Ph.D., CSO, Development, Arecor Ltd.  - Biography 

The strong trend in the biopharmaceutical industry toward concentrated protein products requires new approaches to stabilization to be developed. Presented will be case studies demonstrating novel formulation principles allowing development of liquid protein compositions with superior stability profiles at high-concentrations, with a focus on the control of aggregation as well as other quality attributes such as fragmentation and viscosity.

Wyatt11:45 Characterization of Self-Association at High Concentration by the Calypso® CG-MALS System

Dan SomeDaniel Some, Ph.D., Principal Scientist, Wyatt Technology Corp.

Protein-protein interactions impact the viscosity and stability of biotherapeutics formulated at high concentrations. One of the few techniques capable of measuring and analyzing these interactions is composition-gradient multi-angle light scattering (CG-MALS). We describe the Calypso CG-MALS system and explore some key applications.

 

12:00 pm Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own


Rapid Methods for Protein Stability Assessment (Shared Session) 

1:55 Chairperson’s Remarks

Yatin R. Gokarn, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India


2:00 FEATURED PRESENTATION:

Measuring and Increasing Protein Stability and Solubility

Nick Pace C. Nick Pace, Ph.D., Distinguished Professor, Department of Molecular and Cellular Biology, Texas A&M  - Biography 

This talk will critically discuss the methods used to measure protein stability and review what has been learned recently about the forces stabilizing proteins. Presentation will also cover the best methods for making proteins more stable, including improving the charge distribution and beta-turns on the surface. Finally, we will discuss a new approach for making proteins more soluble.

2:30 High-Throughput Tools for Predicting Aggregation, Viscosity and Solubility of Proteins and mAbs

Yatin R. Gokarn, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India  - Biography 

This presentation will highlight the utility of colloidal stability based HT screening tools for predicting aggregation propensity, and viscoelastic properties of mAbs

3:00 Continuous High-Throughput Monitoring of Protein Formulation Stability Using SMSLS (Simultaneous Multiple Sample Light Scattering)

Wayne Reed Wayne F. Reed, Ph.D., Professor of Physics and Engineering Physics, Department of Physics, Tulane University  - Biography  

SMSLS provides quantitative monitoring on the stability, states of aggregation or degradation, in real time, simultaneously, for many independent samples. It also allows equilibrium properties, such as thermodynamic virial coefficients to be measured and related to kinetics of non-equilibrium processes. Results from case studies on monoclonal antibodies illustrate this approach. Related hydrodynamic data deepen the connection between kinetics and equilibrium properties.

3:30 Refreshment Break in the Exhibit Hall with Poster Viewing

4:15 Characterizing Protein Behavior at High-Concentration in Complex Solutions by Static Light Scattering

Michael Marlow Michael S. Marlow, Ph.D., Staff Scientist, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.  - Biography  

Protein therapeutics typically exceeds the high-concentration threshold resulting in thermodynamic non-ideality, which complicates reliable estimation of critical properties from measurements made dilute conditions. This presentation will discuss the utility of light scattering techniques in bridging the dilute−high-concentration regimes as well as providing insight regarding both the nature of the molecular interactions and the impact of formulation components.

4:45 Comparison of Methods for Characterizing Subvisible Particles Using Manufactured Particles and Microfluidics

Richard Cavicchi Richard Cavicchi, Ph.D., Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology  - Biography  

We use microfabricated particles of precise dimensions to compare sizing methods using commercially available equipment. A microfluidic system combines photographic measurements of particles (including fluorescent images) with electrical measurements of the particle volume via the Coulter Principal. The talk will show how non-spherical reference particles reveal differences in the reported information from commercial instruments.

5:15 Networking Reception with Exhibit & Poster Viewing

6:45 End of Day



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