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 

Thursday, August 22

8:00 am Morning Coffee

Overcoming Challenges in Aggregation and Stability 

8:25 Chairperson’s Remarks

Steven Shire, Ph.D., Consultant; Formerly Genentech, Inc.

8:30 The Role of Dipole Moment in Governing Solution Properties in High-Concentration Antibody Solutions 

Devendra Kalonia Devendra (Davy) S. Kalonia, Ph.D., Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut  - Biography 

Aggregation and viscosity in high-concentration protein solutions can be related to attractive protein-protein interactions. A non-uniform charge distribution on the molecular surface can result in a significant dipole moment. This talk will discuss the dipole moment calculation, experimental measurement and relation to solution viscosity for a number of monoclonal antibodies.


9:00 Effects of Protein Charge Anisotropy on Mechanism and Kinetics of Native State Aggregation

Daniel SeemanDaniel Seeman, Researcher, Dubin Research Group, Department of Chemistry, University of Massachusetts-Amherst  - Biography 

"All proteins aggregate but each in its own way” may apply to unfolding aggregation, but when short-range interactions no longer dominate, native state aggregation can be subject to some general rules. The basis of strategies to suppress or inhibit aggregation depends on interventions appropriate to aggregation mechanism and kinetics.


Delivery Approaches for High-Concentration Protein Formulations 


An Alternative Method for Manufacturing High-Concentration Monoclonal Antibody Formulations for Subcutaneous Delivery

Steven Shire Steven Shire, Ph.D., Consultant; Formerly Genentech, Inc. - Biography 

The high-concentration poses a challenge for manufacturing using standard tangential flow filtration due to the viscosity restrictions during the ultrafiltration / diafiltration unit operation. An alternative approach was investigated where bulk drug substance was concentrated by performing bulk lyo in disposable Lyoguard trays, followed by reconstitution with lower volume than used in the filling of the trays. Formulation studies were conducted to reduce post-reconstitution hypertonicity and viscosity, while maintaining product quality.

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

10:45 A Special Intraocular Contemplation for New Format Antibody Formulations

Dhananjay Jere Dhananjay Jere, Ph.D., Group Leader, Early-Stage Pharmaceutical Development & GLP Supplies, Biologics Europe, F. Hoffmann-La Roche Ltd. - Biography 

Development of protein products to target ocular diseases requires special considerations from the molecular designing aspect and also from the formulation, stability, and regulatory aspect. The protein intended to stay in eye has to be compatible and stable in the intraocular environment. This manuscript describes key development aspects of antibody formulation to make it apt for the intraocular application.

11:15 Challenges in Developing Biologics Device Combination Products: Are They Technical or Regulatory or Both?

Shuxia Zhou Shuxia Zhou, Ph.D., Research Scientist, Drug product Development, Janssen Pharmaceuticals, Johnson & Johnson LLC - Biography 

Combination products with integrated high-concentration product in device are highly market competitive due to demanded dosing convenience. However, developing these products is challenging because of difficulty in developing & manufacturing high-concentration formulation, device design, final product assembly and unclear regulatory requirements. The talk focuses on the strategy in addressing regulatory expectations for a combination product with a new device.

11:45 End of Conference

Day 1 | Day 2 | Short Courses | Download Brochure 


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