David B. Volkin Ph.D.
Takeru and Aya Higuchi Distinguished Professor
Department: Pharmaceutical Chemistry
Office: 2030 Becker Dr., 320C MRB (Multidisciplinary Research Bldg.)
Phone: (785) 864-6262
Fax: (785) 864-5736
Ph.D. 1990 Biochemical Engineering, Massachusetts Institute of Technology
B.A. 1982 Chemistry, University of California, San Diego
- Jayant Arora
- Cavan Kalonia
- Ranajoy Majumdar
- Apurva More
- Samantha Pace
- Srivalli Telikepalli
- Vishal Toprani
As Director of the Macromolecular and Vaccine Stabilization Center (MVSC) at KU, Professor Volkin supervises many post-doctoral researchers and research associates. For their contact information, see http://mvsc.ku.edu.
Lack of stability often limits the use of biopharmaceuticals and vaccines (e.g., proteins, DNA/RNA, virus-like-particles, and viruses) as human medicines. Loss of potency can occur during manufacturing, storage, or administration. Our research objective is to understand the changes in physicochemical properties that accompany the loss of biological activity, and to develop new analytical techniques to monitor these changes at the molecular level. A detailed understanding of the causes and molecular mechanisms of instability will guide the design of more potent and stable biopharmaceutical and vaccine dosage forms. For more information, see our Macromolecule and Vaccine Stabilization Center website at http://mvsc.ku.edu.
Professor Volkin joined the Department of Pharmaceutical Chemistry in 2010. He came to KU with 20 years of R&D experience in the vaccine and biopharmaceutical industry (Merck & Co. and Centocor/J&J). He led groups in formulation development and analytical characterization of vaccines and therapeutic protein drugs. His groups contributed to the development of dozens of candidates used in human clinical trials, including five vaccines and three monoclonal antibodies now approved for commercial use. He is co-author of over 110 scientific papers and book chapters and co-inventor on 14 U.S. patents. He was awarded Fellow status in the American Association of Pharmaceutical Scientists (AAPS) in 2013.
See Publication List from PubMed:
Selected Publications on Characterization and Stabilization of Protein Therapeutics and Vaccines
(2014) Naik S, Kumru OS, Cullom M, Telikepalli SN, Lindboe E, Roop TL, Joshi SB, Amin D, Gao P, Middaugh CR, Volkin DB, Fischer MT, "Probing structurally altered and aggregated states of therapeutically relevant proteins using GroEL coupled to Bio-layer Interferometry", Protein Science, epub.
(2014) Kumru O, Joshi SB, Smith DE, Middaugh CR, Prusik, Volkin DB, "Vaccine instability in the cold chain: Mechanisms, analysis and formulation strategies", Biologicals, epub.
(2014) Alsenaidy MA, Jain NK, Kim JH, Middaugh CR, Volkin DB, "Protein comparability assessments and potential applicability of high throughput biophysical methods and data visualization tools to compare physical stability profiles. Front Pharmacol., epub.
(2014) Alsenaidy MA, Okbazghi SZ, Kim JH, Joshi SB, Middaugh CR, Tolbert TJ, Volkin DB, "Physical stabiity comparisons of IgG1-Fc variants: effects of N-glycosylation site occupancy and Asp/Gln residues at site Asn 297", J Pharm Sci 103:1613.
(2014) Hickey JM, Holtz KM, Manikwar P, Joshi SB, McPherson CE, Buckland B, Srivastava IK, Middaugh CR, Volkin DB, "Mechanism of a decrease in potency for the recombinant influenza A virus hemagglutinin H3 antigen during storage" J Pharm Sci, 103: 821.
(2014) Telikepalli SN, Kumru OS, Kalonia C, Esfandiary R, Joshi SB, Middaugh CR, Volkin DB, "Structural characterization of IgG1 mAb aggregates and particles generated under various stress conditions", J. Pharm Sci, 103: 796.
(2014) Chaudhuri R, Chen Y, Middaugh CR, Volkin DB, "High-throughput biophysical analysis of protein therapeutics to examine the interrelationships between aggregate formation and conformational stability", AAPS J 16: 48.
(2013) Kalonia C, Kumru OS, Kim JH, Middaugh CR, Volkin DB, "Application of radar chart array analysis to visualize effects of formulation variables on IgG1 particle formation as measured by multiple analytical techniques", J Pharm Sci 102: 4256.
(2013) Alsenaidy MA, Kim JH, Majumdar R, Weis DD, Joshi SB, Tolbert TJ, Middaugh CR, Volkin DB, "High-throughput biophysical analysis and data visualization of conformational stability of an IgF1 monoclonal antibody (mAb) after deglycosylation", J Pharm Sci 102: 3942.
(2013) Wang T, Kumru OS, Yi L, Wang YJ, Zhang J, Kim JH, Joshi, SB, Middaugh CR, Volkin DB, “Effect of ionic strength and pH on the physical and chemical stability of a monoclonal antibody antigen-binding fragment", J Pharm Sci 102: 2520.
(2013) Manikwar P, Majumdar R, Hickey J, Thakkar SV, Samra H, Sathish H, Bishop S, Middaugh CR, Weis DD, Volkin DB, “Correlating excipient effects on conformational and storage stability of an IgG1 monoclonal antibody with local dynamics as measured by hydrogen/deuterium-exchange mass spectrometry”, J Pharm Sci 102: 2136.
(2013) Majumdar R, Manikwar P, Hickey J, Samra H, Sathish H, Bishop S, Middaugh CR, Volkin DB, Weis DD, “Effects of salts from the Hofmeister series on conformational stability, aggregation propensity, and local flexibility of an IgG1 monoclonal antibody", Biochemistry 52: 3376.
(2013) Federici M, Lubiniecki A, Manikwar P, Volkin DB, “Analytical lessons learned from selected therapeutic protein drug comparability studies”, Biologicals 41:131.
(2013) Xiao Y, Zeng Y, Alexander E, Mehta S, Joshi SB, Buchman GW, Volkin DB, Middaugh CR, Isaacs SN, “Adsorption of recombinant poxvirus L1-protein to aluminum hydroxide/CpG vaccine adjuvants enhances immune responses and protection of mice from vaccinia virus challenge”, Vaccine 31: 319.
(2013) Middaugh CR, Volkin DB, Joshi SB, “High throughput screening for stabilizers of vaccine antigens” in Novel Immune Potentiators and Delivery Technologies for Next Generation Vaccines, M Singh (ed.), Springer Publishing, 119-143.
(2013) Wang T, Joshi SB, Kumru OS, Telikepalli S, Middaugh CR, Volkin DB, “Case studies applying biophysical techniques to better characterize protein aggregates and particulates of varying size”, in Biophysics for Therapeutic Protein Development, L Narhi (ed.), Springer Publishing, 205-243.