2013 Archived Content

Analytical & Purification Stream

6th Annual
Protein Aggregation and Stability in Biopharmaceuticals

Mechanisms, Measurement, Prediction and Control

May 2-3, 2013

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 you work in formulation and process development for protein-based therapeutics, Protein Aggregation and Stability in Biopharmaceuticals will provide a comprehensive real-world perspective on this challenging arena.

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12:30 pm Conference Registration

Protein Self-Association: Mechanistic Understanding Critical for Successful Formulation 

1:30 Chairperson’s Remarks

Henryk MachHenryk Mach, Ph.D., Principal Scientist, Vaccine Drug Product Development, Merck


1:40 Aggregation versus Association: Theory and Practical Examples

Hans-Joachim SchönfeldHans-Joachim Schönfeld, Ph.D., Senior Principal Scientist, Cardiovascular and Metabolism, F. Hoffmann-La Roche, Inc.

Knowledge of protein/peptide assemblies facilitates drug development. Different methods that identify and quantify association and aggregation phenomena are discussed. Light scattering technologies are particularly useful, regarding the accuracy of their characterizations and throughput. Practical examples will be given for the identification and quantitative description of aggregation and self-association of proteins/peptides without or with modifications. The utility of nomenclature will serve as the context for this presentation and will be stressed.

2:10 Defining the Attributes and Threshold of Aggregated Biotherapeutics that Drive Activation of an in vitro Human Immune Response

Marisa JoubertMarisa Joubert, Ph.D., Senior Scientist, Product Attribute Sciences, Product and Process Development R&D, Amgen, Inc.

Aggregated antibodies can enhance the in vitro innate and adaptive T-cell immune responses of drug naïve human peripheral blood mononuclear cells (PBMC). Here, we have investigated the potential biological impact of different aggregate attributes, including size, molecule type, and particle number, on a population of human PBMC from up to 50 donors (in some cases). The ability of aggregated antibodies to enhance the response of PBMC appears to depend on the number of particles in the micron size range and not to depend on the specific antibody type. The impact of aggregate attributes and the threshold of activation on the immune system in vitro will be discussed.

Malvern Instruments2:40 Avoiding Aggregation & Viscosity Challenges – Early Development Formulation Screening

Kevin MattisonKevin Mattison, Ph.D., Principal Scientist, Bioanalytics, Malvern Instruments

Two properties critical to achieving the CTP for biotherapeutics are the aggregation state and the viscosity of the formulation.  For concentrated formulations, reduction of the viscosity to a level facilitating subcutaneous injection is critical.  Currently, there is no absolute means of “predicting” the influence of sample concentration on the formulation viscosity, and “monitoring” the viscosity is often problematic, due to minimum volume requirements.  The objective of this presentation is to describe recent technological innovations providing automated measurements of protein size and formulation viscosity with sample volume requirements more suitable for early formulation screening.

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

4:00 Problem Solving Breakout Discussions

Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in.

Formulation and Manufacturing Challenges of High Concentration Drug Product Development

Moderator: Danny Chou, Ph.D., Senior Research Scientist, Biologics Development, Gilead Sciences, Inc.

• What issues have you encountered with respect to formulation design and scale-up of high concentration protein formulations?
• How do you deal with issues such as aggregation and non-ideal flow properties as manifested by increased viscosity?
• What strategies are effective for addressing the need to safely deliver high concentration solutions to the patient? Any good in vitro models?

Aggregated Biotherapeutics and Their Potential Biological Consequences

Moderator: Marisa Joubert, Ph.D., Senior Scientist, Product Attribute Sciences, Product and Process Development R&D, Amgen, Inc.

• Biophysical characteristics of aggregates that cause an immune response
• Threshold and level of aggregates that cause a response
• Translation of an aggregate-mediated response in in vitro and in vivo model systems to the clinic

Dilute Solution Properties as Predictive Tool for High Concentration Solution Behavior

Moderator: Sumit Goswami, Ph.D., Senior Scientist, Pharmaceutical R&D, Biotherapeutics Pharmaceutical Sciences, Pfizer

• Important dilute solution parameters such as charge, B22, KD, dipole-dipole interaction, conformational stability
• Dilute solution parameters and potential correlation with high concentration behavior
• Available methods for measuring dilute solution properties - analytical, computational

5:00 End of Day  

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