Biopharmaceutical Process and Quality Consortium4th Biopharmaceutical Summit
May 18-19, 2015: Workshop on "Process Control of Raw Material Variability"
May 20-22, 2015: Advanced Training on PAT and QbD Principles in Biopharmaceuticals
UMass Lowell Inn & Conference Center, Lowell MA
BPQC Summit 2015 Program
If you would like a speaker slot during the summit, please visit Call for Papers and submit an appropriate abstract or complete manuscript.
Session I: Regulatory and Industrial Challenges
Morning Session Chair: Thomas Ryll, Ph.D., Sr. Director of Cell-Culture Development, Biogen (8:40-8:50 a.m.)
PLENARY PRESENTATION: Michael Butler, Ph.D., Distinguished Professor, Univ. of Manitoba, Canada, “Control of Glycosylation During Biopharmaceutical Production ” (8:50-9:30 a.m.)
“T1: Control of Antibody Glycosylation: A Case Study” Rajesh G. Beri, Valerie Canning, Brian Hadley, Jim Heimbach, and Joe Kauten, MSAT, Lonza Biologics, Inc., and Robert Gerber, GSK (9:30-10 a.m.)
Session II: Practices
Afternoon Session Chair: Jack Prior, Ph.D., Sr. Director of Manufacturing Technology, Genzyme
“T4: Controlling Raw Material Variability in Biomanufacturing: A CMO Perspective on Industrial Challenges” Seshu Tummala, Ph.D., Scientist, Mammalian Manufacturing R&D, Lonza Biologics (1:30-2 p.m.)
“T5: Monitor and control raw material variability through supplier collaborations” Ting Wang, Ph.D., Sr. Engineer, Process Development, Amgen (2-2:30 p.m.)
“T6: Raw Material Control Strategies” Dave Kolwyck, Dir. of Global Manufacturing Sciences, Biogen (2:30-3 p.m.)
“T7: Managing Raw Material Variation in Vaccines Production” Jeff Doyle, Manager, Process Analytical Sciences Group, Pfizer (3:10-3:40 p.m.)
“T8: Data Analytics: MVA Approaches to Identify the Impact of Raw Materials on Product and Process Variation in Biologics Manufacturing” Steven Mehrman, Ph.D., Scientist, Janssen Pharmaceuticals (3:40-4:10 p.m.)
PANEL DISCUSSION (4:10 – 5 p.m.)
Panelists: Session Chair and Speakers
For questions: email@example.com, or Seongkyu Yoon: Seongkyu_Yoon@uml.edu; 978-934-5741.