Protein Aggregation and Stability in Biopharmaceuticals

The study and prevention of protein aggregation and its consequences represents one of the most demanding tasks in biomedical research and pharmaceutical manufacturing today. Whether one’s interests lie in protein characterization or analytics, the study of protein aggregation-induced adverse effects or immunogenicity, or you work in formulation and process development for protein-based therapeutics, “Protein Aggregation and Stability in Biopharmaceutical Products” will provide a comprehensive real-world perspective on this challenging arena.

Day 1 | Day 2 | Download Brochure | Speaker Bios 

Recommended Pre-Conference Short Courses* 

Translational Strategies for Development of Monoclonal Antibodies from Discovery to Clinic, Part 1: Focus on Early Discovery - View Detailed Agenda 
& Part 2: Focus on Nonclinical Development to Clinic -
 View Detailed Agenda 

*Separate registration required. 

 

THURSDAY, MAY 8


Aggregation and Integrated Developability Assessment 

1:30 pm Chairperson's Opening Remarks

Elizabeth ToppElizabeth Topp, Ph.D., Dane O. Kildsig Chair and Head, Industrial and Physical Pharmacy, Purdue University

 

1:40 KEYNOTE PRESENTATION:

Protein Aggregation: Characterization to Support Clinical Development

Jamie MooreJamie Moore, Ph.D., Senior Scientist & Director, Early Stage Pharma Development, Genentech, Inc.

Aggregation of protein therapeutics can be defined as self-associating monomeric subunits. In order to understand the impact of aggregates on safety, efficacy and immunogenicity, the aggregates need to be characterized with regard to size, reversibility, conformation, covalent modifications and morphology. This presentation will review case studies evaluating aggregates and their potential impact on clinical development.

2:10 Strategy for Integrated Developability Assessment to Select Candidates for Clinical Development

Hubert KettenbergerHubert Kettenberger, Ph.D., Principal Scientist, Roche Diagnostics GmbH

At the time of selection of a lead molecule (e.g. mAbs, bispecific mAbs, fusion proteins) from a series of lead candidates, it is desirable to assess their stability and physico-chemical properties in order to avoid liabilities during further development. A “developability assessment” results in a prediction of the anticipated development effort for a new lead molecule, using in-silico and small-scale in-vitro methods under short timelines.

2:40 Importance of Orthogonal Methods in the Analysis of Protein Aggregation: Case Studies

Tudor ArvinteTudor Arvinte, Ph.D., Professor, Department of Biopharmaceutics, University of Geneva; CEO, Therapeomic Inc.

 

 

 

3:10 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00 Problem Solving Breakout Discussions

These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

TABLE: Formulations of Biopharmaceutical that Reached the Market: Learning from Examples

Tudor ArvinteModerator: Tudor Arvinte, Ph.D., Professor, Department of Biopharmaceutics, University of Geneva; CEO, Therapeomic Inc.

 

* Examples: Participants are encourages to share information on their contribution to the launch of new products
* What are the most important formulations activities after a successful phase 2 study?
* What formulation issues may occur (or occurred) after successful phase 3?

TABLE: Drug Inhibition of Anti-drug Antibody (ADA) Assays: Understanding and Overcoming Challenges

Maria BarbosaModerator: Maria Barbosa, Ph.D., CA Consultants; former Senior Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb

 

* Regulatory expectations: guidance documents, risk assessment and postmarketing requirements
* Assay selection, optimization and validation: how many assays would be needed for accurate ADA detection?
* The impact of positive control ADA on presumed assay drug tolerance

TABLE: Methodologies to Assess Aggregation Propensities

David Weis Moderators: David Weis, Ph.D., Assistant Professor, Department of Chemistry, University of Kansas & Malgorzata Tracka, Ph.D., Scientist II, Formulation Sciences, MedImmune




TrackaMalgorzata
 

* Given the variety of biomolecules in development, what technologies are the most suitable for aggregation detection? Is it one fits all?
* Viscosity and aggregation propensity and their relationship. Are there solutions to solve both in one go?
* Aggregation hotspots, can we solve the aggregation problem with excipients?

TABLE: Engineering Antibodies to Mitigate Aggregation/Self-Association

Kendrick TurnerModerators: Kendrick Turner, Ph.D., Postdoctoral Fellow, Center for Bio/Molecular Science and Engineering, U.S. Naval Research Laboratory & Chris Lloyd, Ph.D., Scientist, Antibody Discovery & Protein Engineering, MedImmune Ltd




ChrisLloyd
 

* What are the best screening tools for aggregation in the early antibody isolation cascade?
* Can early Research-stage antibody concentrations and formulations accurately predict behavior at later stage higher concentration formulations?
* What strategies are effective for developing aggregation-resistant antibodies?

TABLE: Overcoming Protein Aggregation at High Concentrations

Jennifer MaynardModerator: Jennifer Maynard, Ph.D., Assistant Professor, Chemical Engineering, University of Texas, Austin

 

5:00 Close of Day


Recommended Tuesday Dinner Short Course* 

Overcoming the Challenges of Immunogenicity Assessment - View Detailed Agenda 

Recommended Thursday Dinner Short Course* 

Protein Aggregation: Mechanism, Characterization and Immunogenic Consequences - View Detailed Agenda 

*Separate registration required. 

 

Day 1 | Day 2 | Download Brochure | Speaker Bios