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2013 Archived Content

August 21-22, 2013

Cambridge Healthtech Institute’s Inaugural
Rapid Methods to Assess Quality & Stability of Biologics

Improving Prediction and Screening


Day 1 | Day 2 | Short Courses | Download Brochure 

Wednesday, August 21

7:45 am Registration & Morning Coffee


Regulatory Considerations for Assessing Biopharmaceutical Stability 

8:25 Chairperson’s Remarks

Paul Bigwarfe, Jr., Ph.D., Director, Analytical Sciences, Industrial Operations and Product Supply, Regeneron Pharmaceuticals, Inc.


8:30 KEYNOTE PRESENTATION:

Modern Analytical Techniques for Biologics Impurity Analysis for Meeting the Regulatory Challenges

Jianmei KochlingJianmei Kochling, Ph.D., Director, Quality Control Technical Services, Genzyme, a Sanofi Company - Biography 

Impurity characterization is an important aspect throughout product development and life-cycle management. Strategies for impurity characterization such as when to use modern analytical techniques vs. conventional techniques should be well balanced in order to achieve analytical goals and meet regulatory challenges.

9:00 Regulatory Considerations and Expectations for Assessing Quality and Stability of Biologics

Malgorzata NortonMalgorzata Norton, MS, Biologist, Office of Blood Research and Review, Center of Biologics Evaluation and Research, US Food and Drug Administration - Biography 

An overview of regulatory considerations for stability assessment and handling of results will be discussed. Case-studies demonstrate the use of various methods for investigating and resolving stability issues.


High-Throughput Screening and Assay Development 

9:30 Fluorescence-Based High-Throughput Methods for Rapid Evaluation of Protein Physical and Chemical Instabilities

Vishal NashineVishal C. Nashine, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co. - Biography 

Selection of formulation composition often requires rapid turnaround while the quantity of drug substance is generally limited during the early phase clinical studies. In such cases, material sparing, sensitive, and rapid methods are valuable analytical tools for initial screening of solution conditions. Here, we describe high-throughput methods to assess two major instabilities commonly observed during development of biologics.

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

10:45 High-Throughput Screening to Assess Biophysical Properties of Therapeutic Proteins in Early Development

Martin Lemmerer, Principal Scientist, Integrated Biologics Profiling, Novartis, Inc.- Biography 

During candidate selection, limited material is available for biophysical characterization. We assess and pick winners in a high-throughput manner by utilizing automated liquid handling.

11:15 Poster Highlight Presentation

Forte Bio11:45 Analysis of Protein Structure to Optimize Candidate Screening, Formulations and Process Development

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

Multiple biophysical analytical techniques are imperative to the investigation of the structural stability of proteins. This approach, when combined with the capability for rapid, high-throughput measurements using micro sample volumes, provides a powerful tool for biopharmaceutical development. Applications include screening of candidate molecules, formulations and optimization of purification conditions for downstream processing.

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 PaceC. 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 ReedWayne 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 MarlowMichael 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 CavicchiRichard 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