Bioprocessing/Process Development Group

"Analytical" (held at NCSU BTEC, vendor show) 

• Dr. Afshin Safavi,  BioAgilytix Labs: "Application of Various Immunoassay Platforms in a Regulated Laboratory Environment in Support of Preclinical & Clinical Studies and Manufacturing Processes"
• Dr. Nathaniel Hentz, BTEC, NCSU: "BTEC Analytical Services and Capabilities"
• Dr. Sean McCarthy, Waters Corporation: "Meeting Increased Pressures to Detect and Quantify Host Cell Proteins in Biotherapeutics by LC/MS"
• Dr. Scott Kuzdzal, Shimadzu Scientific Instruments: "The Perfinity Workstation: Achieving Quality through Automation"
• Dr. Bernardo Caceres, FujiFilm Diosynth: "Understanding the Use of Bioassays in a Biomanufacturing Facility"
• Ms. Vaso Vlachos, Mettler-Toledo: "In situ Real-time Monitoring of Bioprocesses Using Process Analytical Technology (PAT)"

"Purification" (vendor show)

• Dr. Ajoy Velayudhan, Grifols, Inc.: "Integration of Purification and Lyophilization in Biotechnology"
• Dr. John M. Jenco, Pall Life Sciences: "Mixed mode chromatography for the purification of biological therapeutics"
• Mr. Matt Westoby, Biogen Idec: "Integrating single-pass tangential flow filtration into biopharmaceutical purification processes"

"Case Studies in Tech Transfer"

• Dr. Brian Nunnally, Pfizer: "Secrets to a Successful Technology Transfer: Downstream"
• Dr. Gregg Nyberg, Amgen: "Challenges Encountered Due to Trace Element Impurities in Cell Culture"
• Doug Osborne, Biogen Idec: "Key Cell Culture Tech Transfer Aspects & Media Prep Lessons Learned for Manufacturing Success"
• Timothy Schofield, Arlenda USA, Inc: "Transfer of Analytical Methods Supporting Biologics and Vaccines"

"Challenges of Multi-product Facility Design for the Manufacture of Biologics"

• Brian Lloyd, Pfizer: "Case Study: "Multi-Product Facility Cleaning and Changeover Integrating Adjacent Commercial and Clinical Biomanufacturing Areas"
• M. Witcher, Integrated Project Services: "Implementation of QbD and Design Space in Multi-product Manufacturing"
• Jeff Odum, Integrated Project Services:  "Next Generation Biomanufacturing"

April 14, 2011

“Single Use Bioprocess Technologies”

• Raj Krishnan, Merck:  “Leveraging single-use bioreactor technologies for upstream biologics production”
• Steve Hudd, Biogen Idec:  "Facility Design and Equipment Selection"
• Bob Steininger, Acceleron: “Design and Operation of Acceleron’s Single Use Facilities – Challenges of Implementing this New Technology”
• Brian Mullan, Eli Lilly: “Transfer, Late Stage Development, and Validation Readiness of a Fully Disposable Process for Monoclonal Antibody Manufacturing”

June 28, 2011

"Bioprocessing PAT Applications: Raman Spectroscopy Monitoring & Control"

• Nicholar Abu-Absi, Bristol Myers Squibb
• Seongkyu Yoon, University of Massachusetts-Lowell
• Maryann Cuellar, Kaiser Optical Systems
• Steve Mehrman, Johnson & Johnson PRD
• John Paul Smelko, Biogen Idec