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
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 |
| 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 |
| 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.)
|
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.