Agenda: 2013 BPQC Summit Agenda
Second Biopharmaceutical Summit
May 15, 2013: Workshop on Next Generation Biopharmaceutical Process – Continuous
May 13-14, 2013: (Advanced Training on Continuous Bioprocessing)
UMass Lowell Inn & Conference Center, Lowell MA
Part I. Advanced Training on Continuous Bioprocessing
May 13-14, 2013 (Monday and Tuesday) 8:30 a.m. - 5:30 p.m.
|
Day 1 (May 13) |
| 8:30 a.m. |
M1: Biopharmaceutical Process Fundamentals (Hyunmin Yi, Tufts) |
| 10:30 a.m. |
M2: Upstream technology for Continuous Bioprocessing – Equipment and Practices (Sadettin Ozturk, Mass Biologics Lab) |
| 12:30 p.m. |
Lunch |
| 1:30 p.m. |
M3. Upstream technology for continuous bioprocessing – Implementation (Thomas Johnson, Genzyme) |
| 3:30 p.m. |
M4: Systems Technology for Continuous Bioprocessing (Seongkyu Yoon, UMass Lowell)
|
|
Day 2 (May 14) |
| 8:30 a.m. |
M5: Continuous Bioseparation (Veena Warikoo, Genzyme)
|
| 10:30 a.m. |
M6. Downstream technology for continuous bioprocessing – Equipment and Implementation focused – (Marc Bisschops, Tarpon Biosystems) |
| 12:30 p.m. |
Lunch |
| 1:30 p.m. |
M7. Simulated Moving Bed (Kathleen Mihlbachler, NJIT) |
| 3:30 p.m. |
M8. Downstream Simulation & Optimization (Jay Yun, Chromworks) |
Part II. BPQC Business Meeting and Reception
May 14, 2013 (Tuesday) 1:00 - 6:30 p.m.
1:00 p.m.
(UMass Lowell) |
Business meeting with consortium member companies For appointment, RSVP (bpqc@uml.edu or seongkyu_yoon@uml.edu, 978-934-4741) |
6:30 p.m.
(ICC) |
RECEPTION (Trainee, BPQC members and all workshop participants are invited |
Part III. Workshop
May 15, 2013 (Wednesday) 8:00 a.m. – 5:00 p.m.
8:00 a.m. |
REGISTRATION |
| 8:30 a.m. |
WELCOME and INTRODUCTION (UMass Lowell and organizer) |
| 8:40 a.m. |
Biopharmaceutical Continuous Processing
Morning Session Chair: Dr. Thomas Ryll, Sr. Director of Cell-Culture Development, Biogen Idec (8:40 – 8:50 a.m.)
PLENARY PRESENTATION 1
Dr. Veena Warikoo, Head of Purification Development, Genzyme (8:50 – 9:30 a.m.)
“Continuous Processing Initiative at Genzyme”
Technologies of Continuous Processing in Biopharmaceutical
Brian Lee, PhD, President and CEO of PBS Biotech, (9:30 – 10:00 a.m.)
“A Novel Pneumatic Single-Use Bioreactor System for Flexible and Scalable Biomanufacturing”
|
| 10:00 a.m. |
BREAK |
| 10:20 a.m. |
Sadettin Ozturk, PhD, Head of Process and Analytical Development, Mass Biologics Lab, UMass Medical School, (10:20 – 10:50 a.m.)
“Disposable Technologies for Continuous Bioprocessing”
Bert Frohlich, PhD, Director of Process Engineering, Shire, (10:50 – 11:20 p.m.)
"Continuous manufacturing experience at Shire”
PANEL DISCUSSION (11:20 – 12:00 p.m.)
Panelists: Dr. Warikoo (Genzyme), Dr. Lee (PBS Biotech), Dr. Ryll (BiogenIdec), Dr. Ozturk (MBL), Dr. Frohlich (Shire)
|
| 12:00 p.m. |
NETWORKING LUNCH |
| 1:00 p.m. |
Afternoon Session Chair: Dr. Jack Prior, Sr. Director of BioProcess Engineering, Genzyme (1:00 – 1:10 p.m.)
PLENARY PRESENTATION 2
Challenges and Innovations in Biopharmaceutical Industry
Kelvin Lee, Ph.D., Professor of Univ. of Delaware, (1:10 – 1:50 p.m.)
“CHOgenome.org – infrastructure to support next generation of development in biopharmaceuticals”
INVITED PRESENTATIONS
Technologies of Continuous Processing in Biopharmaceutical
Holger Kavermann, Ph.D. Sr. Scientist, Roche Diagnostics, (1:50 – 2:20 p.m.)
“Implementation of a rapid Mycoplasma assay: from validation to regulatory acceptance”
Kathleen Mihlbachler, Ph.D, Sr. Lecturer of NJIT, (2:20 – 2:50 p.m.)
“Challenges of SMB in Bioprocessing”
|
| 2:50 p.m. |
BREAK |
| 3:10 p.m. |
Marc Bisschops, Ph.D., CSO of Tarpon Biosystems, Inc., (3:10 – 3:40 p.m.)
“Single Use, Continuous Downstream Processing: The next great efficiency leap in Biopharmaceutical Manufacturing”
Kevin Bittorf, Ph.D., VP of Process Development and Analytical Sciences, Living Proof, Inc., (3:40 – 4:10 p.m.)
“QbD and Pricing of Continuous Manufacturing”
PANEL DISCUSSION (4:10 – 4:50 p.m.)
Panelists: Dr. Prior (Genzyme), Dr. Lee (UoD), Dr. Mihlbachler (NJIT), Dr. Bittorf (Living Proof), Dr. Bisschops (Tarpon)
|
| 4:50 p.m. |
CLOSING REMARKS |
| 5:00 p.m. |
RECEPTION AND NETWORKING POSTER SESSION
20-30 posters will be prepared |