Research interest is in the area of protein delivery and immunotherapy.
Current research projects:
1. Development of lipidic nano particle containing therapeutic proteins and is supported by NHLBI/NIH. The overall goal of the project is to improve therapeutic efficacy of protein based therapies for bleeding and lysosomal disorders using a multidisciplinary approach involving Biophysics/Bioengineering, immunology and pharmacokinetics/Pharmacodynamics.
2. Re-activating Memory T Cells in the Microenvironment of Human Tumors and development of in situ vaccination. This project is supported by NCI/NIH (Dr. Bankert, PI, Balu-Iyer Co-PI). Our aim is to to rationally develop therapeutic intervention by understanding the molecular mechanism of TCR arrest.
3. Develop novel strategies to treat food allergies and autoimmune conditions using the tolerogenic properties of biomolecules.
4. Formulation and delivery of Monoclonal antibody based products: Understand and develop strategies to improve efficacy of antibody based therapeutics particularly given via sc route of administration
Education and Training:
PhD, Indian Institute of Science (1993)
MS/BA, Madurai Kamaraj University, India (1987)
Postdoctoral Fellow, Pharmaceutical Sciences - drug delivery, SUNY - University at Buffalo
Adjunct Faculty (2000-present)
Associate Director (2000-present)
Associate Professor (2006–2012)
Assistant Professor (2000–2006)
Assistant Professor (2000)
Research Assistant Professor (1997–2000)
Post Doctoral Associate (1993–1996)
Post Doctoral Associate (1993)
Awards and Honors:
Fellow American Association of Pharmaceutical Sciences (2015)
Visionary Innovator Award (2015)
Innovation in Biotechnology Award (2012)
Exceptional Scholar Teaching Innovation Award (2011)
Inventor of the Year award 2011 (2011)
Nominated for Inventor of the year 2010 (2010)
Outstanding Reviewer - 2009 (2009)
Member, Editorial Board (2006)
Teacher of the Year Award (2006)
Reviewer Abstracts for poster and podium presentations (2005)
Guest Editor (2005)
Reviewer North Carolina Biotechnology Center Institutional Development (2004)
Reviewer Cooperative Grants Program (2003)
Mail reviewer (2003)
Inventor of the Year Award (2002)
First Patent Award (2002)
Immunotherapy: Develop lipid mediated tolerance strategies to overcome unwanted immune responses (protein and antibody therapeutics, allergies, autoimmune conditions and gene therapy)
Protein delivery and immunotherapy: Adopts an interdisciplinary approach of biophysics/bioengineering, pharmacokinetic and pharmacodynamic and immunology.
Protein formulation: Physicochemical and analytical methods of assessing protein structure, function, and stability in developing improved dosage forms.
February 2002–December 2019 Development and pharmacology of novel lipidic rAHF and Biotherapeutics NHLBI Role: Principal Investigator $1,000,000
June 2016–June 2018 Investigation of formulation variables on sc bioavailability of monoclonal antibody therapeutics Role: Principal Investigator $148,000
July 2005–June 2006 Product Development Fund University at Buffalo Role: Co-Principal Investigator $33,000
Composition for less immunogenic and long circulating Protein-Lipid complex (2011)
Method for treating coagulation disorders (2011)
Method of complexing a protein by the use of a dispersed system and protein Type: Regular (2010)
Composition and method of preparation of micro particulate IL-12 (2010)
RECONSTITUTION MEDIUM FOR PROTEIN AND PEPTIDE FORMULATIONS Docket Number: 5847 Type: Other Other Type: Divisional (2008)
Compositions of less immunogenic and long circulating protein-lipid complex Type: Regular (2007)
Method for treating blood coagulation disorders Type: Regular (2007)
COMPOSITIONS AND METHODS FOR LESS IMMUNOGENIC PROTEIN FORMULATIONS Docket Number: 5785 Type: Other Other Type: Europe (2007)
COMPOSITIONS AND METHODS FOR LESS IMMUNOGENIC PROTEIN FORMULATIONS Docket Number: 5785 Type: Other Other Type: Canada (2007)
Composition and method of preparation of liposomal microparticulate IL-12 f Type: Regular (2006)
RECONSTITUTION MEDIUM FOR PROTEIN AND PEPTIDE FORMULATIONS Docket Number: 5847 Type: Other Other Type: Europe (2006)
COMPOSITIONS AND METHODS FOR LESS IMMUNOGENIC PROTEIN FORMULATIONS Docket Number: 5785 Type: Other Other Type: PCT (2006)
RECONSTITUTION MEDIUM FOR PROTEIN AND PEPTIDE FORMULATIONS Docket Number: 5847 Type: Other Other Type: Canada (2006)
COMPOSITIONS AND METHODS FOR LESS IMMUNOGENIC PROTEIN FORMULATIONS Docket Number: 5785 Type: Other Other Type: Continuation-in-Part (2005)
Method and composition of pegylated phosphoserine complex (2005)
RECONSTITUTION MEDIUM FOR PROTEIN AND PEPTIDE FORMULATIONS Docket Number: 5847 Type: Regular (2004)
RECONSTITUTION MEDIUM FOR PROTEIN AND PEPTIDE FORMULATIONS Docket Number: 5847 Type: Other Other Type: PCT (2004)
COMPOSITIONS AND METHODS FOR LESS IMMUNOGENIC PROTEIN FORMULATIONS Docket Number: 5785 Type: Regular (2004)
COMPOSITIONS AND METHODS FOR LESS IMMUNOGENIC PROTEIN FORMULATIONS Docket Number: 5785 Type: Other Other Type: PCT (2004)
COMPOSITION OF THE RECONSTITUTIONAL MEDIUM FOR PROTEIN AND PEPTIDE FORMULAT Docket Number: 5847 Type: Provisional (2003)
METHOD FOR PREPARING PROTEIN-LIPID COMPLEXES WITH LOW IMMUNOGENICITY Docket Number: 5785 Type: Provisional (2003)
Stabilization of Taxane formulations (2002)
METHOD AND APPARATUS FOR HEATING AND CONTROLLING THE TEMPERATURE OF ULTRA S Docket Number: 0330 Type: Regular (1986)
COMPOSITIONS AND METHODS FOR LESS IMMUNOGENIC PROTEIN FORMULATIONS Docket Number: 5785 Type: Other Other Type: Japan
COMPOSITIONS AND METHODS FOR LESS IMMUNOGENIC PROTEIN FORMULATIONS Docket Number: 5785 Type: Other Other Type: Australia
COMPOSITIONS AND METHODS FOR LESS IMMUNOGENIC PROTEIN FORMULATIONS Docket Number: 5785 Type: Other Other Type: New Zealand
Gaitonde P; Ramakrishnan R; Chin J; Kelleher R; Bankert R; Balu-Iyer SV. Exposure to Factor VIII in the presence of Phosphatidylserine induces hyporesponsiveness to Factor VIII challenge in Hemophilia A mice. Journal of Biological Chemistry. 2013; 288.
K. A. Shetty, E. P. Merricks, R. Raymer, N. Rigsbee, T.C. Nichols and Balu-Iyer SV. Soy phosphatidylinositol containing lipid nanoparticle prolongs the plasma survival and hemostatic efficacy of B-domain deleted recombinant canine Factor VIII in Hemophilia A dogs. J Pharm Sci. 2016; 105(10).
Trummer BJ; Iyer VS; Balu-Iyer SV; O'Connor R; Straubinger RM. Physicochemical properties of EGF receptor inhibitors and development of a nanoliposomal formulation of gefitinib. Journal of Pharmaceutical Sciences. 2012; 101.
Gaitonde P; Straubinger RM; Bankert R; Balu-Iyer SV. Down-regulation of CD40 signal and induction of TGF- beta by Phosphatidylinositol, mediates reduction in immunogenicity against recombinant human Factor VIII. Journal of Pharmaceutical Sciences. 2012; 101.
Bhansali SG; Balu-Iyer SV; Morris ME. Influence of route of administration and liposomal encapsulation on blood and lymph node exposure to the protein VEGF-C156S. J Pharm Sci. 2012; 10.
Peng A; Ding H; Kosloski M; Balu-Iyer SV. PEGylation of FVIII-PI Complex: Pharmacokinetics and Immunogenicity in Hemophilia A Murine Model. AAPS Journal. 2012; 14.
Peng A; Doty A; Pisal D; Balu-Iyer SV. Phosphatidylinositol induces fluid phase formation and packing defects in phosphatidylcholine model membranes. Chemistry and Physics of Lipids. 2012; 165.
Kagan L; Turner M; Balu-Iyer SV; Mager DE. Subcutaneous absorption of monoclonal antibodies: role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats. Pharm Res. 2012; 29.
Kosloski M; Peng A; Varma P; Miclea RD; Mager DE; Balu-Iyer SV. Immunogenicity and pharmacokinetic studies of recombinant Factor VIII containing lipid cochleates. Drug Delivery. 2011; 8 (20.
Gaitonde P; Balu-Iyer SV. In vitro Immunogenicity Risk-assessment of Therapeutic Proteins in Preclinical Setting. Methods in Molecular Biology. 2011; 716 (.
Peng A; Straubinger RM; Balu-Iyer SV. Phosphatidylinositol containing lipidic particle reduces inhibitor development and catabolism of factor VIII in hemophilia A mice. AAPS Journal. 2011; 12 (2.
Pisal D; Balu-Iyer SV. Phospholipid binding improves plasma survival of Factor VIII. Thrombosis and Haemostasis. 2011; 104 (.
Pisal DS; Balu-Iyer SV. Phospholipid Binding Lowers Immunogenicity of Human Recombinant Factor VIII in von Willebrand Factor Knockout Mice. Thrombosis and Haemostasis. 2011; 105.
Korotchkina LG; Ramani K; Balu-Iyer SV. Folding consideration of therapeutic proteins. Prog Mol Biol Transi Sci. 2008; 83.
Ramani K; Miclea RD; Gaitonde P; Straubinger RM; Balu-Iyer SV. Passive Transfer of Polyethyleneglycol to Liposomal-Recombinant Human FVIII Enhances its Efficacy in a Murine Model for Hemophilia A. Journal of Pharmaceutical Sciences. 2008; 97.
Themistou E; Singh I; Balu-Iyer SV; Alexandridis P; Neelamegham S. Change in Solution Structure of Human Blood Protein von Willebrand Factor Caused by Shear. Polym. Prepr. (Am. Chem. Soc., Div. Polym. Chem.). 2008; 49.
Ramani K; Miclea RD; Purohit VS; Straubinger RM; Mager DE; Balu-Iyer SV. Phosphatidylserine Containing Liposomes reduce Immunogenicity of Recombinant Human Factor VIII in a Murine Model of Hemophilia A. Journal. Pharmaceutical Sciences. 2008; 97.
American Society for Biochemistry and Molecular Biology (2005)
American Society for Biochemistry and Molecular Biology; nominated to become a Regular member in the American Society for Biochemistry and Molecular Biology (ASBMB) (2005–present)
Biophysical Society; Member (2003–present)
International Society on Thrombosis and Haemostasis; Member (2002–present)
American Association of Pharmaceutical Scientists (2000)
American Association of College Pharmacy; Member (2000)
American Association of Pharmaceutical Scientists; Member (2000–present)
Biophysical Society; Member (1995–1998)
"sc delivery of biotherapeutics" Dicerna, Dicerna (2015)
"Tricks of Modified Release of biologics" AAPS Annual Meeting, AAPS (2015)
"Role of immunogenicity in biological drug development" Workshop on Pharmacodynamics and Systems Pharmacology, Dublin City University (2014)
"Protein drugs; Formulation approaches for stabilizing biologics" FIP World congress of Pharmacy and Pharmaceutical Sciences, Dublin, FIP (2013)
"Reverse Vaccination and subcutaneous route – A novel strategy to mitigate immunogenicity" Abbvie, Abbvie (2013)
"Immunogenicity and Pharmacokinetics of subcutaneous administered therapeutic proteins" AAPS Biotechnology, AAPS (2013)
"Immunogenicity and pharmacokinetics of subcutaneously administered therapeutic proteins" AAPS NBC, AAPS, National Biotechnology Conference (2013)
"Lipid mediated Induction of Immunological Tolerance" Immunogenicity Summit 2012, Cambridge Health Tech (2012)
"Development of next generation protein therapeutics" NIAC, School of Pharmacy and Pharmaceutical Sciences (2012)
"Reverse Vaccination Lipid renders protein tolerogenic" AAPS Biotechnology, AAPS (2012)
"Mitigation of immunogenicity of Factor VIII by lipid mediated tolerance" IIR Annual Meeting, IIR (2012)
"Immunogenicity of Therapeutic Proteins" IIR Annual Meeting, IIR (2011)
"The pharmacokinetics and lymphatic exposure of recombinant human vascular endothelial growth factor VEGF-C156S after iv and sc administration" Pharmacology Day, University at Buffalo (2010)
"Phosphatidylserine and immune regulation to protein therapeutics" 11th annual immunogenicity for biotherapeutics, IIR USA (2010)
"(1) Multifunctional formulation approaches to reduce immunogenicity of protein therapeutics" New Jersey Pharmaceutical Association of Science and Technology, New Jersey Pharmaceutical Association of Science and Technology (2010)
"(2) Rational mechanism based formulation development to overcome Immunogenicity" Cambridge Health Tech PEP talk, Cambridge Heath Institute (2010)
"Immunogenicity of FVIII, a rational mechanism based formulation development" Protein stability conference, University of Colorado (2009)
"Development of lipidic recombinant Factor VIII to improve safety and efficacy of replacement therapy" Wyeth Andover (2009)
"Development and pharmacokinetic evaluation of liposomal VEGF-C156S." Great Lakes Symposium (2008)
"Formulation and biophysical characterization of liposomes encapsulating VEGF-C156S for PK/PD studies." Sigma Xi Research Conference (2008)
"Formulation and biophysical characterization of liposomes encapsulating VEGF-C156S for PK/PD studies." UB-Pfizer Conference (2008)
Organizing committee, Symposium nano for Medicine; Organize a national symposium on nanomedicine; Member (2009)
Department of Pharmaceutical Sciences Admissions committee; Member (2007–2019)
Life Sciences IRDF; Reviewer (2007)
Center for Protein Therapeutics; Member (2007)
Integrated NanoMedicine Search committee - Biological Sciences; Member (2007)
Integrated NanoMedicine Search committee; Member (2006)
Life Sciences Panel IRDF; To review proposals submitted for IRDF; Reviewer (2004)
UB2020 Integrated nano structures -chemical engineering; One of the author of the UB2020 integrated nano structures; Member (2003)
Curriculum committee; Member (2002)
Pharmaceutical Instrumentation Facility; Oversee pharmaceutical sciences Instrumentation facility, participate as Co I in shared equipment grants, train users managing the facility and trained users that have contributed to over 100 publication in peer reviewed journals, participated in several; Other (2000)
Pharmaceutical Sciences Instrumentation Facility; To oversee pharmaceutical instrumentation facility, participate in shared equipment proposal writing, train new users Successfully managing this instrumentation facility over several years that have contributed to over 100 peer-reviewed journal article,; Other (2000)
SOPPS Safety committe; Member (2000)
Accreditation Facilities sub-committe; Member
Author, UB2020 Integrated nano systems, white paper; Other
Committee; Therapeutic Protein Immunogenicity Focus GroupAAPS; Other
Course Reviewer; American Association of Pharmaceutical Scientists; Other
Distinguished speaking faculty; Cambridge Health Tech; Other
Distinguished speaking faculty; Institute for International Research; Other
Editorial Board; Asian Chemical Letters - Editorial Board; Other
Editorial Advisory Board; International Journal of Clinical research and Drug Development - Editorial Advisory Board; Other
Editorial advisory Board; Journal of Pharmaceutical Sciences - Editorial advisory Board; Other
Editorial advisory Board; Recent Patents on Endocrine, Metabolic & Immune Drug Discovery - Editorial advisory Board; Other
Faculty advisory committee, Integrated nano systems strategic strength; Member
Faculty Search Committee; Member
Graduate Student Admissions committee; Member
Graduate Student Admissions sub-committee; Member
Grant Reviewer; Israel Science Foundation; Other
Incubator and start-up committe; Member
Instrumentation Facility; Other
Member; American Association of Pharmaceutical Scientists; Other
Member; American Society for Biochemistry and Molecular Biology; Other
Participant, iHUB; Innovation HUB (iHUB), Science and Technology Transfer and Economic Outreach, University at Buffalo. iHUB is a federal grant awarded to UB from Economic Development Administration (EDA) to foster innovation, job creation and private capital investment in; Other
Pharm D faculty advisor; Academic advising for Pharm D students (3-4 students per year and total of 12-16 students); Other
Reviewer; Trinity College Ireland; Other
Reviewer/Presenter; Biotechnolgy 101 AAPS; Other
Undergraduate affairs committee; Member
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