|
October 13, 2011
|
"Analytical" (held at NCSU BTEC, vendor show)
|
|
November 10, 2011
|
"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"
|
|
December 8, 2011
|
"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"
|
|
February 9, 2012
|
"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"
|
|
March 8, 2012
|
"Vaccines"
-
Kathryne S. Auernik: "Process Analytical Technology in Varicella Vaccine Manufacturing"
-
Nikki Burkhalter, Ph.D., Pfizer: "Ensuring Robustness in Conjugate Vaccine Processes"
-
Siva Sakhamuri, Ph.D., Sanofi-Pasteur Biologics: "Post-approval Manufacturing Process Changes"
-
Raghu Shivappa, Ph.D., Novartis Vaccines and Diagnostics: "Challenges of Influenza Vaccine Manufacturing"
|
|
April 19, 2012
|
"2nd Annual Single Use Bioprocess Technologies Symposium" (full day event, vendor show)
-
Ryan Hutchinson, M.S., Healthcare: "Extractables and leachables for Single-Use Systems"
-
Lindsey Ingram, Biogen Idec: "Let's Get Flexible - Implementing Disposable Cell Culture Technologies in GMP"
-
Nephi Jones, M.S., Thermo Fisher Scientific: "Single use bioreactor optimization for critical two phase mass transfer challenges in animal cell culture scale-up and process development"
-
Paul Kubera, M.S., ABEC, Inc.: "Mixing and Mass Transfer Performance in Large Scale Single Use Bioreactors"
-
Myles Lindsay, Ph.D., Grifols Therapeutics, Inc.: "Single-use versus reusable chromatography: comparison of downstream process impurity clearance"
-
Devin McCann, Biogen Idec: "Case Study: Performance of Reduced Volume Flushing and Flux Rate for Millistak +POD's, within a Closed System for Primary Clarification"
-
Stewart McNaull, Ph.D., Fujifilm Diosynth: "Development and Implementation of a Single Use Manufacturing Platform for Rapid Capacity Expansion and Operational Flexibility"
-
Venkatesh Natarajan, Ph.D., EMD Millipore: "Use of Single-Use Technologies in Downstream Purification of mAbs - A Case Study"
|
|
May 17, 2012
|
"Fill Finish"
-
Steven Cottle, Grifols, Inc.: "Construction of a Product Temperature Model & Utilizing a QbD Approach in Lyophilization Cycle Development"
-
Friedrich Harder, Vetter Pharma: "Current Trends in Aseptic Faiclity Design"
-
Keith Nguyen, Merck & Co., Inc.: "Differences Between 'Identical' Fill/Finish Facilities"
-
Jean-Sebastien Parisse, Aseptic Technologies S.A.: "The 'Closed Vial Technology': A New Option for Aseptic Fill and Finish Operations"
|
The Biotechnology Center initiated the Bioprocessing/Process Development Group to provide a forum for process development scientists and engineers to discuss bioprocessing issues. The group meets monthly with speakers from the industry, technology vendor companies and regulatory experts.
