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

8:30 KEYNOTE PRESENTATION:

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

Jianmei 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 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 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 Standardized Assays for Rapid Assessment of Potency: The Key to Success

Michael G. Tovey, Ph.D., INSERM Director, Research, Laboratory of Biotechnology and Applied Pharmacology, ENS-Cachan, Villejuif, France - Biography

Biological activity is an essential quality attribute that serves as a link to clinical efficacy. Conventional assays may be inadequate to detect differences in stability resulting from a change in manufacturing. A validated standardized cell-based assay platform has been developed that allows quantification of drug potency within 2 hours and that reduces assay variation to a minimum as illustrated by case studies for different biologics.

11:45 Sponsored Presentation (Opportunity Available)

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

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 Networking Refreshment Break

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