Arwa S. El Hagrasy, Ph.D.
Associate Professor, Faculty of Pharmacy, Cairo University
Kasr Elaini Street, Cairo, Egypt
Email: ,
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Summary
· Three years experience in the Pharmaceutical Industry and four years of Academic experience, with an in-depth understanding of vibrational spectroscopy as well as formulation and process development.
· A strong academic and technical background in the application of Process Analytical Technology (PAT) for solid state characterization during the discovery phase to formulation and process monitoring during pilot/manufacturing scale.
· Hands on experience with the development, implementation and transfer of spectroscopic techniques.
· Effective collaboration with multidisciplinary groups within R&D and Manufacturing Technology teams.
· Excellent presentation and interpersonal communication skills, with a good record of symposium presentations and scientific publications.
Education
Ph.D. Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA, USA, 2004
B.Sc. Pharmaceutical Sciences, Cairo University, Egypt, 1994: Excellent with Honors
Foreign Pharmacy Graduate Examination Committee (FPGEC) certification, August 2008
Academic Experience
School of Chemical Engineering, Purdue University, West Lafayette, IN, USA
Post-Doctoral Research Associate 7/2010-present
· Development of Educational Modules for FDA Reviewer Education in Pharmaceutical Manufacturing Technology Topics, National Institute for Pharmaceutical Technology and Education (NIPTE), (2012)
· Studying continuous wet granulation using a pilot-scale twin screw granulator
Characterization of raw material attributes pertaining to the process
Mechanistic understanding of the effect of formulation and process variables on granule attributes
Optimization of the process for better control of critical quality attributes of the product
Faculty of Pharmacy, Cairo University, Egypt
Associate Professor, Pharmaceutics and Industrial Pharmacy 7/2012-present
Assistant Professor, Pharmaceutics and Industrial Pharmacy 8/2008-7/2010
· Teaching of pharmaceutical sciences courses to undergraduate and graduate pharmacy students
· Development of undergraduate and graduate level courses
· Mentoring undergraduate students during the academic year for extracurricular activities
Industrial Experience
Bristol-Myers Squibb (BMS) Company, New Brunswick, NJ, USA
Research Investigator II 1/2007-6/2007
Drug Product Process and Packaging Development, Biopharm R&D
· Handled PAT method development and transfer for late stage projects
· Participated in a group effort to evaluate the safety of using PAT instrumentation in processing areas
Process Analytical Technology Scientist 4/2004-1/2007
Process Analytical Technology Group, Process R&D
· Provided spectroscopic support during method development, implementation and transfer
- Supported formulation and process development for early/late stage projects
- Designed PAT methods for real-time process monitoring and optimization
- Provided recommendation on optimum formulation and processing conditions
· Evaluated new technologies for implementation in pharmaceutical process understanding, control and improvement
· Investigated and resolved deviations during implementation of newly developed PAT methods for process monitoring
· Participated in several due diligence meetings for presentation of PAT activities for late stage projects
· Involved in on-site hands on training for the new FDA PAT review team members
· Trained and mentored other team members
· Primary author for multiple scientific publications and symposium presentations
· Effectively collaborated with multiple departments across the organization for successful project execution
Professional Affiliations
American Association of Pharmaceutical Scientists (AAPS)
International Society for Pharmaceutical Engineering
Society for Applied Spectroscopy
Awards and Honors
The first Büchi NIR Award: 2001, Frankfurt, Germany
Professional Activities
2006-present: Editorial Advisory Board Member, Journal of Pharmaceutical Innovation
2009-2011: Executive Editor, Journal of Advanced Research, The Official Journal of Cairo University
Symposium Presentations
1. Twin Screw Granulation: Influence of Formulation Parameters. A.S. El Hagrasy and J.D. Litster, 5th International Granulation Workshop in Lausanne, Switzerland, 2011.
2. Process Analytical Technology Tools for Pharmaceutical Quality Management. A.S. El Hagrasy, Thirteenth Conference of the Scientific Association of Colleges of Pharmacy in the Arab World, Misr University for Science and Technology, Cairo, Egypt, 2010.
3. Applications of Process Analytical Technology in Pharmaceutical Product Development. A. El Hagrasy, Tablet Manufacturing Technologies, Cairo, Egypt, 2010.
4. Challenges Associated with Near-Infrared Spectroscopic Method Transfer. A. El Hagrasy. Eastern Analytical Symposium, Somerset, NJ, 2006.
5. Application of Raman Spectroscopy for Quantitative Monitoring of Tablet Coating, S-Y. Chang, A. El Hagrasy, S. Paruchuri, S. Kothari, D. Divyakant, and S. Kiang, Eastern Analytical Symposium, Somerset, NJ, 2005.
6. Raman Spectroscopy for Quantitative Monitoring of Tablet Coating, S-Y. Chang, A. El Hagrasy, S. Paruchuri, S. Kothari, D. Divyakant, and S. Kiang, The Federation of Analytical Chemistry and Spectroscopy Societies, Quebec City, Canada, 2005.
7. A Risk Managed Approach for Implementation of Spectroscopic Techniques in Powder Blend Monitoring, A. El Hagrasy, S-Y. Chang and S. Kiang, FDA Science Forum, Washington D.C., 2005
8. Applying Process Analytical Technology to Improve Efficiency and Reliability of Spray Coating, S-Y. Chang, A. El Hagrasy, S. Kiang, S. Kothari, S. Paruchuri, H. Guo, D. Divyakant, W. Early and H. Stomato, FDA Science Forum, Washington D.C., 2005
9. Raman Spectroscopy for Quantitative Monitoring of Solid Dosage Manufacturing Process. S-Y. Chang, A. El Hagrasy, W. Early, H. Guo, D. Li, S. Kothari, S. Paruchuri and V. Nesarikar, International Forum for Process Analytical Technology, Arlington, VA, 2005.
10. Applications of Multivariate Analysis in the Pharmaceutical Product Development and Quality Assurance, A. El Hagrasy, S. Kiang and S-Y. Chang, ASQ Fall Technical Conference, Roanoke, VA, 2004
11. Advances in Near-Infrared Monitoring and Characterization of Powder Blending, A. S. El-Hagrasy, M. Delgado-Lopez and J. K. Drennen III, American Association of Pharmaceutical Scientists Annual Meeting, Salt Lake City, UT, 2003.
12. Characterization and Monitoring of Powder Blend Homogeneity Using Near-IR Spectroscopy, A. El-Hagrasy, L. Begic, F. D'Amico and J. K. Drennen, American Association of Pharmaceutical Scientists Annual Meeting, Denver, CO, 2001.
13. Statistical Algorithms for Near-IR Determination of Powder Blend Homogeneity, A. El-Hagrasy, H. R. Morris, F. D'Amico and J. K. Drennen, American Association of Pharmaceutical Scientists Annual Meeting, Indianapolis, IN, 2000.
14. Monitoring Powder Blend Homogeneity Using Near-Infrared, A. El-Hagrasy, H. R. Morris, P. Lunney, and J. K. Drennen, 10th International Diffuse Reflectance Conference, Chambersburg, PA, 2000.
15. Monitoring Powder Blend Homogeneity Using Near-Infrared, A. El-Hagrasy, H. R. Morris, P. Lunney, and J. K. Drennen, American Association of Pharmaceutical Scientists Annual Meeting, New Orleans, LA, 1999.
16. Monitoring Powder Blend Homogeneity Using Near-Infrared, A. El-Hagrasy, H. R. Morris, P. Lunney, and J. K. Drennen, Regional Duquesne Chemistry Symposium, Duquesne University, Pittsburgh, PA, 1999.
Publications
1. A. El-Hagrasy, H. R. Morris, F. D'Amico, R. A. Lodder and J. K. Drennen. Near Infrared Spectroscopy and Imaging for the Monitoring of Powder Blend Homogeneity. J. Pharm. Sci., 90(9): 1298-1307, 2001.
2. A. El-Hagrasy, H. R. Morris, F. D'Amico, R. A. Lodder and J. K. Drennen NIR Method Development for Monitoring of Pharmaceutical Powder Blending. NIR News, 13(2): 8-11, 2002.
3. A. El-Hagrasy and J. K. Drennen. PAT methods provide process understanding: characterization of intra-shell versus inter-shell mixing kinetics in V-blenders. NIR News, 15(2): 8-11, 2004.
4. A. El-Hagrasy, F. D'Amico, and J. K. Drennen III. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation. J. Pharm. Sci. 95(2): 392-406, 2006.
5. A. El-Hagrasy, M. Delgado-Lopez and J. K. Drennen III. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part II: Qualitative near-infrared models for prediction of blend homogeneity. J. Pharm. Sci. 95(2): 407-421, 2006.
6. A. El-Hagrasy and J. K. Drennen III. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics. J. Pharm. Sci. 95(2): 422-434, 2006.
7. A. El Hagrasy, S-Y. Chang, D. Desai and S. Kiang. Application of Raman spectroscopy for quantitative in-line monitoring of tablet coating. Amer. Pharm. Rev., 9(1): 40-45, 2006.
8. A. S. El Hagrasy, S-Y. Chang and S. Kiang. Evaluation of risk and benefit in the implementation of near-infrared spectroscopy for monitoring of lubricant mixing. Pharm. Dev. Tech., 11(3): 303-312, 2006.
9. D. Jayawickrama, A. El Hagrasy and S-Y. Chang. Raman applications in drug manufacturing processes. Amer. Pharm. Rev., 9(7):10-17, 2006.
10. A. S. El Hagrasy, S-Y. Chang, D. Desai and S. Kiang. Raman spectroscopy for the determination of coating uniformity of tablets: assessment of product quality and coating pan mixing efficiency during scale-up. J. Pharm. Innovation. 1(1): 37-42, 2006.
11. A. S. El Hagrasy and W. P. Findlay. Process analytical technology enabling process understanding of a blending operation. Amer. Pharm. Rev., 10(3): 56-63, 2007.
12. A. N. Elmeshad and A. S. El Hagrasy. Characterization and optimization of orodispersible mosapride film formulations. AAPS PharmSciTech., 12(4): 1384-1392, 2011
13. A.S. El Hagrasy and J.D. Litster. Twin screw granulation: Influence of formulation parameters”, Proceedings 5th International Granulation Workshop, Paper #4, Lausanne, Switzerland, 2011.
14. A.S. El Hagrasy, J.R. Hennenkamp, M.D. Burke, J.J. Cartwright and J.D. Litster. Twin screw granulation: Influence of formulation parameters on granule properties and growth behavior. Powder Technol., doi:10.1016/j.powtec.2012.04.035, 2012.
15. A. S. El Hagrasy. Development of Near-Infrared Spectroscopic and Imaging Methods for Process Control of Pharmaceutical Powder Blending. Ph.D. Dissertation, 2004.
Languages:
English and Arabic –fluently written and spoken.
Arwa S. El Hagrasy Page 1