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Diosynth Biotechnology Publications and Presentations
Published by Admin on 2010/1/8 (6700 reads)
2009 PUBLICATIONS and PRESENTATIONS
1. A DOE Approach to Setting System Suitability Criteria for HPLC Assays. Smith, C., Ragonese-Baldwin, H., and Adams, G. WCBP 2009 Conference. San Francisco, CA. January 12, 2009. 2. Biopharmaceutical Industry Overview. Clontz, L. Class for Product/Process Validation Course (PHSC 338 & 508) at Campbell University School of Pharmacy. Buies Creek, NC. January 12, 2009. 3. Microbial Limit and Bioburden Tests – A discussion on the latest hot topics. Clontz, L. National Pharmaceutical Sciences Group. Toronto, Canada. January 19, 2009. 4. Facility Controls. Clontz, L. Class for Product/Process Validation Course (PHSC 338 & 508) at Campbell University School of Pharmaceutical Sciences. Buies Creek, NC. January 28, 2009. 5. Development and Scale-Up of Protein Purification Using the Baculovirus Expression System. Parekh, D. The Williamsburg BioProcessing Foundation Conference. San Antonio, TX. February 2-4, 2009. 6. Microbial Identification Using Phenotypic Methods. Clontz, L. Microrite Seminar. San Francisco, CA. February 19, 2009. 7. Applying Risk Management to Technology Transfer Programs. Moore, C. and Baran, E. IBC’s 4th Annual Technology Transfer for Biopharmaceuticals Conference. Carlsbad, CA. March 2-3, 2009. 8. Process Development, Characterization, Large Scale Production, and Quality Control of Follow-on Biologics. Mostafa, S. Antibody Development & Production. Carlsbad, CA. March 4-6, 2009. 9. Process Development, Characterization, Large Scale Production, and Quality Control of Follow-on Biologics. Mostafa, S. Audio recording of presentation for IBC's On-Demand Online Educational Series, part of a 3 or 4 part series that will be uploaded at the BioProcess International website as a webinar. April 17, 2009. 10. Thinking Tools for Kids. Easterly, M.C. Partners for the Advancement of Gifted Education Super Saturday. Cary, NC. April 18, 2009. 11. Thinking Tools for Kids. Rabideau, S. Partners for the Advancement of Gifted Education Super Saturday. Cary, NC. April 18, 2009. 12. Complex Recombinant Proteins – when one size doesn’t fit all. Yi, Y., Bowers, K., Adams, G., and Acharya, P. BPI Analytical & Quality Summit. La Jolla, CA. May 4-6, 2009. 13. ASQ Certification Exams: Test Taking Tips and Tricks. Easterly, M.C. American Society for Quality’s Quality in the Triangle Conference, Raleigh, NC. May 12, 2009. 14. Analytical Considerations During the Development of a Biosimilar mAb. Adams, G. BIO 2009. Atlanta, GA. May 20, 2009. 15. Process Development Characterization, Large Scale Production, and Quality Control of Follow-on Biologics. Mostafa, S. BioProcess & Process Development Seminar. NCSU, BTEC. Raleigh, NC. September 24, 2009. 16. Site-to-Site Tech Transfer for Downstream Biopharmaceutical Processing: A Look into the Requirements for a Successful Process Transfer from an External Client into a CMO Facility. Patton, K. BioProcess International Conference & Exhibition. Raleigh, NC. October 12, 2009. 17. Best Practices and Risk Management as Applied to Technology Transfer. Harter, C. and Parekh, D. BioProcess International Conference & Exhibition. Raleigh, NC. October 13, 2009. 18. Strategy Discussion Forum Panelist Member for Plant Capacity: Successful Strategies to Deal with Too Much of It. Wheat, J. BioProcess International Conference & Exhibition. Raleigh, NC. October 13, 2009. 19. Facility Optimization: Experience of a Custom Contract Manufacturer from Broad Scope to the Details. Wheat, J. BioProcess International Conference & Exhibition. Raleigh, NC. October 14, 2009. 20. Creation of a Well-Characterized Small Scale Model for High-Throughput Process Development. Zhang, D. and Mostafa, S. BioProcess International Conference & Exhibition. Raleigh, NC. October 14, 2009. 21. Increasing the Efficiency of Developmental Accelerated Stability Studies through the use of Differential Scanning Calorimetry (DSC) and Dynamic Light Scattering (DLS). Bowers, K. IBC’s 9th Annual Formulation Strategies for Protein Therapeutics. Raleigh, NC. October 15, 2009. 22. Strategy Discussion Forum Moderator for Navigating the Pathway to Regulatory Approval from Phase I to PAI. Simon, K. BioProcess International Conference & Exhibition. Raleigh, NC. October 16, 2009. 23. Strategy Discussion Forum Panelist for Tech Transfer Across the Atlantic: Charting Regulatory Course Through These Waters. McNaull, S. BioProcess International Conference & Exhibition. Raleigh, NC. October 16, 2009. 24. Biofilm Prevention: Control by Design. Clontz, L. 3rd Annual Biofilm Networking Group Conference. BTEC, Raleigh, NC. November 10, 2009. 25. Process Control and Risk Assessment Management. Moore, C. 3rd Annual Biofilm Networking Group Conference. BTEC, Raleigh, NC. November 10, 2009. 26. Practical Applications of Metabolomics in Process Development. Farnsworth, S. Metabolon Workshop. North Carolina Biotechnology Center. December 2, 2009.
PUBLICATIONS (GENERAL)
1. Creation of a Well-Characterized Small Scale Model for High-Throughput Process Development. Zhang, D. and Mostafa, S. BioProcess International Supplement Series. Vol. 7, Supplement 7, pp. 28-31. October 2009 2. Tuning Oxygen Transfer in Small Scale Fermenters to Mimic Manufacturing Productivity: A Case Study. Fairlee, J. and McNaull, S. 2009 BioProcess Yearbook.
PRESENTATIONS (PROCESS DEVELOPMENT)
1. A DOE Approach to Setting System Suitability Criteria for HPLC Assays. Smith, C., Ragonese-Baldwin, H., and Adams, G. WCBP 2009 Conference. San Francisco, CA. January 12, 2009. 2. Biopharmaceutical Industry Overview. Clontz, L. Class for Product/Process Validation Course (PHSC 338 & 508) at Campbell University School of Pharmacy. Buies Creek, NC. January 12, 2009. 3. Microbial Limit and Bioburden Tests – A discussion on the latest hot topics. Clontz, L. National Pharmaceutical Sciences Group. Toronto, Canada. January 19, 2009. 4. Facility Controls. Clontz, L. Class for Product/Process Validation Course (PHSC 338 & 508) at Campbell University School of Pharmaceutical Sciences. Buies Creek, NC. January 28, 2009. 5. Development and Scale-Up of Protein Purification Using the Baculovirus Expression System. Parekh, D. The Williamsburg BioProcessing Foundation Conference. San Antonio, TX. February 2-4, 2009. 6. Microbial Identification Using Phenotypic Methods. Clontz, L. Microrite Seminar. San Francisco, CA. February 19, 2009. 7. Applying Risk Management to Technology Transfer Programs. Moore, C. and Baran, E. IBC’s 4th Annual Technology Transfer for Biopharmaceuticals Conference. Carlsbad, CA. March 2-3, 2009. 8. Process Development, Characterization, Large Scale Production, and Quality Control of Follow-on Biologics. Mostafa, S. Antibody Development & Production. Carlsbad, CA. March 4-6, 2009. 9. Process Development, Characterization, Large Scale Production, and Quality Control of Follow-on Biologics. Mostafa, S. Audio recording of presentation for IBC's On-Demand Online Educational Series, part of a 3 or 4 part series that will be uploaded at the BioProcess International website as a webinar. April 17, 2009. 10. Thinking Tools for Kids. Easterly, M.C. Partners for the Advancement of Gifted Education Super Saturday. Cary, NC. April 18, 2009. 11. Thinking Tools for Kids. Rabideau, S. Partners for the Advancement of Gifted Education Super Saturday. Cary, NC. April 18, 2009. 12. Complex Recombinant Proteins – when one size doesn’t fit all. Yi, Y., Bowers, K., Adams, G., and Acharya, P. BPI Analytical & Quality Summit. La Jolla, CA. May 4-6, 2009. 13. ASQ Certification Exams: Test Taking Tips and Tricks. Easterly, M.C. American Society for Quality’s Quality in the Triangle Conference, Raleigh, NC. May 12, 2009. 14. Analytical Considerations During the Development of a Biosimilar mAb. Adams, G. BIO 2009. Atlanta, GA. May 20, 2009. 15. Process Development Characterization, Large Scale Production, and Quality Control of Follow-on Biologics. Mostafa, S. BioProcess & Process Development Seminar. NCSU, BTEC. Raleigh, NC. September 24, 2009. 16. Site-to-Site Tech Transfer for Downstream Biopharmaceutical Processing: A Look into the Requirements for a Successful Process Transfer from an External Client into a CMO Facility. Patton, K. BioProcess International Conference & Exhibition. Raleigh, NC. October 12, 2009. 17. Best Practices and Risk Management as Applied to Technology Transfer. Harter, C. and Parekh, D. BioProcess International Conference & Exhibition. Raleigh, NC. October 13, 2009. 18. Strategy Discussion Forum Panelist Member for Plant Capacity: Successful Strategies to Deal with Too Much of It. Wheat, J. BioProcess International Conference & Exhibition. Raleigh, NC. October 13, 2009. 19. Facility Optimization: Experience of a Custom Contract Manufacturer from Broad Scope to the Details. Wheat, J. BioProcess International Conference & Exhibition. Raleigh, NC. October 14, 2009. 20. Creation of a Well-Characterized Small Scale Model for High-Throughput Process Development. Zhang, D. and Mostafa, S. BioProcess International Conference & Exhibition. Raleigh, NC. October 14, 2009. 21. Increasing the Efficiency of Developmental Accelerated Stability Studies through the use of Differential Scanning Calorimetry (DSC) and Dynamic Light Scattering (DLS). Bowers, K. IBC’s 9th Annual Formulation Strategies for Protein Therapeutics. Raleigh, NC. October 15, 2009. 22. Strategy Discussion Forum Moderator for Navigating the Pathway to Regulatory Approval from Phase I to PAI. Simon, K. BioProcess International Conference & Exhibition. Raleigh, NC. October 16, 2009. 23. Strategy Discussion Forum Panelist for Tech Transfer Across the Atlantic: Charting Regulatory Course Through These Waters. McNaull, S. BioProcess International Conference & Exhibition. Raleigh, NC. October 16, 2009. 24. Biofilm Prevention: Control by Design. Clontz, L. 3rd Annual Biofilm Networking Group Conference. BTEC, Raleigh, NC. November 10, 2009. 25. Process Control and Risk Assessment Management. Moore, C. 3rd Annual Biofilm Networking Group Conference. BTEC, Raleigh, NC. November 10, 2009. 26. Practical Applications of Metabolomics in Process Development. Farnsworth, S. Metabolon Workshop. North Carolina Biotechnology Center. December 2, 2009.
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