Protein Stability and Effect on the Immune System

Monoclonal antibodies continue to command a large market share with numerous entities in clinical trials for a variety of therapeutic indications. In many cases, the doses required for therapeutic efficacy are large, limiting options for antibody delivery and administration. We have developed a novel formulation strategy that allows for subcutaneous injection of highly concentrated antibody (~290 mg/ml) with a low apparent viscosity (<50 cP). Upon in vitro dilution, the protein is found to be monomeric with full activity, as monitored by dynamic light scattering and antigen binding. Overall, this method of generating high-concentration, low-viscosity solutions is readily generalizable and could lead to improved administration and patient compliance, providing new opportunities for the biotechnology industry.

Furthermore, a big problem in the field of biopharmaceutics is the development of anti-drug antibodies (ADAs). After repeated doses, some patients can develop an immune response against therapeutics. We are interested in the nature of this response and looking at ways to prevent it.

Highlighted in news: 

UT Cockrell Engineering School website 
The Alcalde

 

Primary researchers:
        Andrea Miller (co-supervised)
        Aileen Dinin (co-supervised)
        Joshua R. Laber

 

Key collaborators:

        Profs. Keith P. Johnston and Tom Truskett  

        Dept. of Chemical Engineering, University of Texas at Austin
 

Funding:

        NIH R21 Grant

        Norman Hackerman Advanced Research Program Grant

        Industrial Contracts