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Agenda

Biopharmaceutical Process and Quality Consortium
4th 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.

Part I. Workshop

May 18 (Monday): 8 a.m. – 5 p.m.

8 a.m. REGISTRATION
8:30 a.m. WELCOME AND INTRODUCTION (UMass Lowell and organizer)
8:40 a.m.

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.)

10 a.m. BREAK
10:20 a.m. “T2: Product Quality Pitfalls - Variable and Complex Materials in Biologics Manufacturing” Mark D. Leney, Ph.D., Deputy Director, Quality and Regulatory Affairs, Mass Biologics Lab - UMass Medical School (10:20-10:50 a.m.)
“T3: A case study in technical risk assessment strategy for upstream bioprocess raw materials” Terrence Dobrowsky, Ph.D., Scientist, Biogen (10:50-11:20 a.m.)
PANEL DISCUSSION (11:20 a.m. - Noon)
Panelists: Session chair and Speakers
Noon NETWORKING LUNCH
1:30 p.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.)

3 p.m. BREAK
3:10 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


May 19 (Tuesday): 8 a.m. - 5 p.m.

8 a.m. REGISTRATION
8:20 a.m. Session III: Emerging Technologies (8:20-8:30 a.m.)
Morning Session Chair: Rashmi Kshirsagar, Ph.D., Director of Cell Culture Development, Biogen
“T9: Downstream Platform Process Optimization for mAbs with New and Emerging Technologies” Kumar Dhanasekharan, Ph.D., Director of Process Development, Cook Pharmica LLC (8:30-9 a.m.)
“T10: Monitoring Multiple Attributes of Biopharmaceuticals in Development, Production, and Quality Control of Biopharmaceuticals with Mass Detection” Sean M. McCarthy, Ph.D., Principal Scientist, Waters (9-9:30 a.m.)
“T11: X-ray Fluorescence Method Development for Monitoring Inorganics in Raw Materials: Challenges, Strategies and Case Studies” Jessica Mondia, Ph.D., Scientist, Biogen (9:30-10 a.m.)
“T12: Predicting Cell Culture Robustness through Poloxamer Characterization” Amr S. Ali, Scientist, Biogen (10-10:30 a.m.)
10:30 a.m. BREAK
10:40 a.m. Session IV: Biopharmaceutical Consortium Session – Driving for Future
Session Chair: Kevin Bittorf, Ph.D., Pharmaceutical Executive in Residence, Chair of Advisory Board (10:40 – 10:50 a.m.)
Advanced Biomanufacturing Consortium”, Seongkyu Yoon, Ph.D., Assistant Professor, Univ. of Massachusetts Lowell (10:50-11:10 a.m.)
Continuous Biomanufacturing”, Mark-Henry Kamga, Ph.D. Candidate, Univ. of Massachusetts Lowell (11:10-11:30 a.m.)
Glycosylation Modeling and Control”, Sha Sha, Ph.D. Candidate, Univ. of Massachusetts Lowell (11:30-11:50 a.m.)
Noon NETWORKING LUNCH
1:30 p.m. Session V: Path-forward
Session Chair: Sadettin Ozturk, Ph.D., Associate Deputy Director, Process Development, MassBiologics Lab
“T13: How to Integrate Raw Material Variability in QbD Risk Assessment” Sun Koo Kim, Ph.D. Sr. Scientist, Bayer, CA (1:30-2 p.m.)
“T14: Mitigation of Chromatography Adsorbent Lot Variability through a Molecule Specific Binding Strength Test and an Adaptive Control Strategy” Carson Tran, Engineer I, Biogen (2-2:30 p.m.)
“T15: Dynamic Control Strategies: A current view of "What goes in, What goes on, and What comes out” Brian Fahie, Ph.D., Director of Technical Development, Biogen (2:30-3 p.m.)
“T16: Application of the CHO Genome to CHO HCP Studies” Kelvin Lee, Ph.D., Professor, Department of Chemical Engineering, University of Delaware (3-3:30 p.m.)
PANEL DISCUSSION (3:30 – 4 p.m.)
Panelists: Session Chair and Session V Speakers
4 p.m. CLOSING REMARKS (Carl Lawton, Ph.D., Associate Professor and Director of Mass Biomanufacturing Center, UML)
5 p.m. RECEPTION AND NETWORKING POSTER SESSION
20-30 posters will be prepared

Part II. BPQC Business Meeting and Reception

May 20, 2015 (Wednesday), 9 a.m. - 4 p.m.

9 a.m.
(Location TBD)
Business meeting with consortium member companies. For appointment, RSVP (bpqc@uml.edu or seongkyu_yoon@uml.edu, 978-934-4741)

Part III. Advanced Training on PAT/QbD in Biopharmaceuticals

May 20-22 2015 (Wednesday through Friday), 8 a.m. - 5 p.m./Falmouth 300, North Campus, UML

Day 1 - Multivariate Data Analysis
Module # Description Type Instructor
M1, 8 a.m. Principle Component Analysis, Review Lecture NS
M2, 9 a.m. Tutorial on Principal Component Analysis Tutorial NS/SY
M3, 10 a.m. Partial Least Squares, Review Tutorial SY
M4, 11 a.m. Tutorial on Partial Least Squares Tutorial NS/SY
Noon Lunch    
M5, 1 p.m. Batch Evolution Modeling I (Modeling) Lecture NS
M6, 2 p.m. Batch Evolution Modeling II (Validation) Lecture SY
M7, 3 p.m. Case Study Demonstration Tutorial NS/SY
M8, 4 p.m. Tutorial on Batch Evolution Modeling Tutorial NS/SY

Day 2 - Batch Modeling
Module # Description Type Instructor
M9, 8 a.m. Batch Level Modeling I Lecture NS
M10, 9 a.m. Tutorial on Raw material and CC impact on CQA Tutorial NS/SY
M11, 10 a.m. Batch Level Modeling II Lecture SY
M12, 11 a.m. Tutorial on CQA Prediction Tutorial NS/SY
Noon Lunch    
M13, 1 p.m. DOE Concepts Lecture SY
M14, 2 p.m. Modeling, Optimization and Validation Lecture NS
M15, 3 p.m. Tutorial on Modeling Building with Media/CQA Tutorial NS/SY
M16, 4 p.m. Tutorial on Robustness and Design Space Tutorial NS/SY

Day 3 - QbD and Design Space Assessment
Module # Description Type Instructor
M17, 8 a.m. Design Space Lecture SY
M18, 9 a.m. Tutorial on Design Space Building Tutorial NS/SY
M19, 10 a.m. CQA Specification Lecture NS
M20, 11 a.m. Tutorial on CQA Specification Tutorial NS/SY

For questions: bpqc@uml.edu, or Seongkyu Yoon: Seongkyu_Yoon@uml.edu; 978-934-5741.