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
8:25 Chairperson’s Remarks
Dhananjay Jere, Ph.D., Group Leader, Early-Stage Pharmaceutical Development & GLP Supplies, Biologics Europe, F. Hoffmann-La Roche Ltd.
8:30 Challenges in Developing High-Concentration Protein Formulations
Donna 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, 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, 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, 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 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.
11:45 Characterization of Self-Association at High Concentration by the Calypso® CG-MALS System
Daniel 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
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
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 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 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, 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
Day 1 | Day 2 | Short Courses | Download Brochure