Yunhua Hu, PhD
Address: **** ******** **** ****, ****, NC 27519
To seek for an advanced research and development position in the areas of pharmaceutical formulation, polymeric material research and applications, and for an employment located in RTP area.
HIGHLIGHTS OF WORK EXPERIENCES
1. Experiences in pharmaceutical formulation and product development.
2. Experiences in controlled drug delivery technologies including microencapsulation, nanoparticles, hot-melt extrusion matrices, coating, lipid matrices, self-emulsifying delivery systems, hydrogels, softgel capsule.
3. Experiences in oral soft gel capsule, injectible, fast dissolving film and topical dosage forms for a variety of small molecular drugs, nutrients and bio-macromolecules.
4. Experiences in stability and degradation of active ingredients and finish products.
5. Experiences in bio/chemical analytical method development.
6. Experiences in writing and reviewing batch paperwork records, scale-up and pilot experiments and technology transfer.
Dec. 2009-present, Sr. Scientist, Banner Pharmcaps Inc., High Point, NC.
1. Softgel capsule formulation development for a number of APIs and nutritional supplements.
2. Site targeting drug delivery (to the colon) platform development, IP disclosure.
3. Hot-melt extrusion matrices, extended release fill formulations (IP disclosure preparation), fast dissolving films, chewables and gums.
4. Development of enteric softgel mass and non-animal gel mass for softgel encapsulation. Accomplishment includes IP.
5. Formulation project management including GMP batch record writing and review, raw material qualification, batch preparation for clinic study, finish product assay and stability study.
Nov. 2003-Dec. 2009, Research Scientist, Idexx Laboratories, Pharmaceutical Division, Durham, NC.
1. Drug delivery technology developments:
a) Injectable sustained release delivery system based on drug-fatty acid salt, drug-amino acid ester salt, drug-lipid complex technologies;
b) Lipid gel drug delivery system for topical applications;
c) Protein-, siRNA-lipid complex injectable hydrogel delivery system.
2. Formulation and drug product developments:
a) Topical gel formulation delivering multi-active drugs to animal ear to effectively cure chronic infections. Accomplishment includes IP, FDA submission and formulation being licensed to a major pharmaceutical company.
b) Injectable antibiotic-fatty acid salt formulations (macrolide, cephalosporin, florfenicol) for long-lasting action. Accomplishment includes IP and FDA submission.
c) siRNA Injectable in situ hydrogel which possesses sustained release feature. Accomplishment includes IP, achieving high concentration and sustained release that exceeded client’s request.
3. Analytical method developments for new drug product development, including GC, HPLC, LC-MS, release rate test, raw material and finished product physiochemical characterizations, stability and forced degradation.
4. Process developments: Developing scale-up process; preparing formulations under GMP for clinic studies, evaluating and selecting packaging materials.
5. As a project leader developed project strategies and plans/timelines, coordinated associates’ work, searched literature, designed and hand-on performed experiments, summarized and reviewed data, and reported results.
Aug. 2000-Oct. 2003, Research Scientist, Carnegie Mellon University, Pittsburgh, PA.
1. Established a gene delivery system based on calcium phosphate/DNA mano-particles for bone tissue engineering, work published.
2. Established project on new injectible starch-based biodegradable hydrogels for cell delivery in tissue engineering, fund granted from National Institute of Health.
3. Established novel approach to construct three-dimensional porous polymer scaffolds as implants to delivery cells and growth factors in bone tissue engineering, work published.
4. Evaluated biocompatible and biodegradable polymers, such as PLA/PLGA, fibrin, hyaluronic acid, for controlled drug release and bone tissue engineering. Fibrin was selected as main component in building tissue engineering implants in situ by inkjet printing, part of the work published.
Jul. 1998-Jul. 2000, Postdoctoral Associate, Oregon Health Science University, Portland, OR.
1. Established biodegradable polymeric macroporous matrices as implants for delivery of growth factors and cells for bone tissue regeneration, work published.
2. Fabricated porous polysaccharide sponges for cartilage regeneration.
3. Evaluated interaction of polymer material with cells and tissues. Cell growth was significantly improved through grafting RGD peptide on hydrophobic PLGA porous scaffold surface, work published.
4. Established methodology to propare microspheres (microencapsulation) for controlled drug release targeting brain cancer, work published.
May, 1997-Jul. 1998, Post-doctoral Associate, Colorado State University, Fort Collins, CO.
1. Developed a new approach to fabricate biodegradable polymeric macroporous scaffolds as implants for bone tissue regeneration, work published.
2. Synthesized and evaluated surface property of fluorinated polymer materials, work published.
3. Synthesized and evaluated physiochemical properties of self-assembly fluorinated liquid crystal grafted polysiloxanes mono-layers.
4. Synthesized and evaluated polysiloxanes modified with poly(ethylene glycol) grafts containing activated ester group which possesses specific protein and DNA segment adsorption properties, work published.
5. Investigated ultra-high molecular weight polyethylene for artificial joints replacement, and surface modification to improve its lubrication, work published.
Ph.D., Polymer Science, 1995, Wuhan University, Wuhan, China.
References are available upon request.
1. N. Yu, Y. Hu, Q. Fang, Extended release of IBU from Hot-melt extrusion matrices, Post to be presented to 2012 AAPS in Chicago, Nov 2012.
2. Y. Hu, Q. Fang, M. Hariharan, Incorporating polymers in softgel capsules for extended release, poster presentation at the 39th Controlled Release Society Conference, July 2012, Quebec, Canada.
3. Y. Hu, Q. Fang, N. Yu, S. Majuru, M. Hariharan, Development and Characterization of a Capsule Dosage Form for Colon Targeting Drug Delivery, poster presentation to 2010 AAPS in New Orleans in Nov. 2010.
4. Y. Hu, Q. Fang, N. Yu, S. Majuru, M. Hariharan, Developing enteric gel mass for softgel encapsulation, poster presentation to 2010 AAPS in New Orleans in Nov. 2010.
5. S. Carter, Y. Hu, J. Heflin, Q. Fang, N. Yu, S. Majuru, M. Hariharan, Gel permeation chromatography (GPC) characterizations of gelatin used in softgel encapsulation, poster presentation to 2010 AAPS in New Orleans in Nov. 2010.
6. Y. Hu, Q. Fang, N. Yu, S. Majuru, Developing softgel dosage form for colonic drug delivery, poster presentation at Controlled Release Society Conference, July 2010, Portland, OR.
7. Y. Hu, H. Fu and J. O. Hollinger, A novel calcium phosphate-based gene delivery system for bone tissue engineering, J Biomed Mater Res, 2005, 74A, 40-48.
8. Y. Hu, S.R. Winn, Ian Krajbich and J.O. Hollinger, Porous polymer scaffolds surface modified with arginine-glycine-aspartic acid enhance bone cell attachment and differentiation In Vitro, J Biomed Mater Res, 2003, 64A, 583-590.
9. Y. Hu, D.W. Grainger, S.W. Winn and J.O. Hollinger, Fabrication of poly( -hydroxy acid) foam structures with multiple solvent systems, J Biomed Mater Res, 2002, 59(3), 563-572.
10. N. Xia, Y. Hu, D.W. Grainger and D.G. Castner, Functionalized poly(ethylene glycol)-grafted polysiloxane monolayers for control of protein binding, Lamgmuir, 2002, 18, 3255-3262.
11. T.M. Meese, Y. Hu, R.W. Nowak and K.G. Marra. Surface studies of coated polymer microspheres and protein release from tissue-engineered scaffolds, J Biomater Sci, Polym Ed, 2002,13, 141-151.
12. Y. Hu, J.O. Hollinger, and K.G. Marra, Controlled release from coated microparticles embedded in tissue-engineered scaffolds. J Drug Targeting, 2001, 9, 431-438.
13. G.P. Beauregard, Y. Hu, D.W. Grainger and S.P. James, Silylation of poly-L-lysine hydrobromide improves dissolution in apolar organic solvents, J Appl Polym Sci, 2001,79(12), 2264-2271.
14. K.G. Marra, P.G. Campbell, Y. Hu and J.O. Hollinger, “Fundamental physiological factors directing bone tissue engineering design and development”, in “Tissue Engineering and Biodegradable Equivalents”, Editors: Lewandrowski, Trantolo, Gresser, Yaszemski and Altobelli, 2001, p25-43.
15. D.F. Emerich, S.R. Winn, Y. Hu, J. Marsh, P. Snodgrass, D. La Freniere, T. Wiens, B.P. Hassler and R.T. Bartus, Injectable chemotherapeutic microspheres and glioma I: Enhanced survival following implantation into the cavity wall of debulked tumors, Pharm Res, 2000, 17(7), 767-775.
16. S.R. Winn, Y. Hu, C. Sfeir and J.O. Hollinger, Gene therapy approaches for modulating bone regeneration, Adv Drug Del Rev, 2000, 42, 121.
17. R. Winter, P.G. Nixon, G.L. Gard, D.G. Castner, N.R. Holcomb, Y-H. Hu, D.W. Grainger, Photopolymerized acrylate copolymer films with surfaces enriched in sulfur pentafluoride (SF5) chemistry, Chem Mater, 1999, 11, 3044-3049.
18. S.R.Winn, J.M.Schmitt, D. Buck, Y. Hu, D. Grainger, J.O. Hollinger, Tissue-engineered bone biomimetic to regenerate calvarial critical-sized defects in athymic rats, J Biomed Mater Res, 1999, 45(4), 414-421.
19. Y. Hu, D.W. Grainger, D. Castner, Perfluorinated nematic liquid crystal side chain-grafted polysiloxanes immobilized as on gold, Polymer Preprints, 1998, 39(2), 946-7.
20. Z. Zong, S. Dong, Y. Hu, Y. Xu and W. Liu, Synthesis and complexation properties of polystyrene supported polymeric thiacrown ether, Eur Polym.J, 1998, 34(5/6), 761-766.
21. C. Fan, C. Zhou, Y. Hu, Y. Mei and R. Zhuo, Synthesis and characterization of polyester-polyanhydrides, Acta Polymerica Sinica, 1998, (6), 652-657.
22. Y. Hu, R. Zhuo, "Synthesis and drug release properties of aliphatic polyester anhydrides", Chemical Research in Chinese Universities, 1997, 18(11), 1888-1892.
23. Y. Hu, R. Zhuo, "The synthesis and drug release property of polysiloxanes bearing pendant long alkyl ether groups", Acta Polymerica Sinica, 1997, (1), 62-67.
24. Y. Hu, R. Zhuo. "The preparation of long-chain fatty acid esters of cellulose in LiCl/DMAc system and their drug release properties", Chinese Journal of Applied Chemistry, 1996, (2), 7-10.
25. Y. Hu, R. Zhuo, "The synthesis and drug release properties of polyorganosiloxanes bearing pendant long alkyl ester and cholesteryl ester groups", Chemical Research in Chinese Universities, 1996, 17(2), 319.
26. Y. Hu, R. Zhuo, "Chemical modification of EVA for drug release application", Chemical Research in Chinese Universities, 1995, 11(1), 87.
27. Y. Hu, R. Zhuo, "Synthesis and drug release property of polysiloxanes bearing long side chain", Chinese Journal of Reactive Polymers, 1994, 3(1-2), 39.
28. S. Dong, H. Hu, Y. Zhao, et al.,"Studies on chelating resins XXVII. Chemical modification of mercapto-amine resins and their adsorption properties", Journal of Wuhan University, 1995, 41(2), 161.
29. S. Dong, H. Hu, L. Fan, et al., "The studies on chelating resins XXI. The preparation and properties of IPN mercapto-amine chelating resins", Acta Polymerica Sinica, 1994, (3), 316.
30. Y. Hu, Y. Xu, C. Ping, S. Dong, "Study on chelating resins XIX, The synthesis and adsorption properties of chelating resins based on chitosan", Ion exchange and Adsorption, 1992, 8(3), 229.
31. S. Dong, F. Liu, Y. Hu, "Studies on chelating resins XIII. Syntheses and adsorption properties of new chelating resin with a polythioether backbone bearing pyridylamino groups", Chemical Research in Chinese Universities, 1990, 11(5), 511.
32. S. Dong, Y. Hu, Y. Xu, "Studies on polymeric crown ethers IV. Further research on polymeric thiacrown ethers with polythiaether backbone", Journal of Wuhan University, 1992, (1), 68.
33. S. Dong, Y. Hu, "Studies of polymeric crown ethers I. The syntheses and complexation properties of polymeric thiacrown ethers with polyether backbone", Chemical Research in Chinese Universities, 1992, 8(1), 21.
34. S. Dong, Y. Hu, "Studies on polymeric crown ethers III. Synthesis and complexation properties of macrocyclic polythiaethers", Chinese Journal of Applied Chemistry, 1991, 8(4), 16.
35. S. Dong, W. Tang, Y. Hu, "Study on chelating resins XII. Syntheses and adsorption properties of new chelating resins of amino-isopropyl mercaptan type with polythioether backbone", Acta Polymerica Sinica, 1990, (2), 142.
36. S. Dong, Y. Hu, "Studies on polymeric crown ethers II. Syntheses and complexation properties of polymeric thiacrown ethers with polythiaether backbone", Acta Polymerica Sinica, 1990, (4), 399.