Proteins are becoming increasingly important as therapeutic agents. Due to their inherent instability, proteins present a unique challenge in the development of stable formulations. We study the mechanisms by which proteins are damaged in liquid and dried formulations, and the mechanisms by which additives inhibit this damage. Our work on protein aggregation includes not only studies on therapeutic proteins, but also investigations into the amyloid fibril formation by proteins involved in human diseases such as systemic amyloidosis and Parkinson's disease. In addition, we are studying the use of high hydrostatic pressure to disaggregate and refold proteins.
Education, Licensure & Certifications
- BS, Duke University (Zoology)
- MS, Oregon State University (Zoology)
- PhD., University of Southwest Louisiana (Biology)
- Development and testing of advanced analytical instruments for particle characterization
- Effects of end-user handling and mishandling on quality of therapeutic protein products
- Mechanisms for protein degradation and stabilization in pharmaceutical formulations
Publications and Presentations
Effects of Product Handling Parameters on Particle Levels in a Commercial Factor VIII Product: Impacts and Mitigation. Ueda T, Nakamura K, Abe Y, Carpenter JF.
J Pharm Sci. 2019 Jan;108(1):775-786. doi: 10.1016/j.xphs.2018.08.022. Epub 2018 Sep 6.
Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues. Nejadnik MR, Randolph TW, Volkin DB, Schöneich C, Carpenter JF, Crommelin DJA, Jiskoot W. J Pharm Sci. 2018 Aug;107(8):2013-2019. doi: 10.1016/j.xphs.2018.04.005. Epub 2018 Apr 14. PMID: 29665382
Protein Nanoparticles Promote Microparticle Formation in Intravenous Immunoglobulin Solutions During Freeze-Thawing and Agitation Stresses. Pardeshi NN, Zhou C, Randolph TW, Carpenter JF. J Pharm Sci. 2018 Jul;107(7):1852-1857. doi: 10.1016/j.xphs.2018.03.016. Epub 2018 Mar 27.