Biopharmaceutical Process and Quality Consortium

2014 Summit Agenda

May 27-28, 2014: Advanced Training on PAT and QbD Principles in Biopharmaceuticals
May 29-30, 2014: Workshop on PAT and QbD in Biopharmaceutical Industry 
UMass Lowell Inn & Conference Center, Lowell MA

Part I. Advanced Training on PAT/QbD in Biopharmaceuticals

May 27-28, 2014 (Tuesday and Wednesday), 8 a.m. - 5 a.m.

Day 1 (May 27) Type Instructor
8 a.m. M1 Batch Evolution Modeling I (Modeling) Lecture NS
9 a.m.
M2 Batch Evolution Modeling II (Validation) Lecture SY
10 a.m.
M3 Case Study Demonstration Tutorial NS/SY
11 a.m.
M4 Tutorial on Batch Evolution Modeling Tutorial NS/SY

12 a.m.

Lunch
1 p.m.
M5 Batch Level Modeling I Lecture NS
2 p.m.

M6 Tutorial on Raw material and CC impact on CQA

Tutorial NS/SY
3 p.m.
M7 Batch Level Modeling II Lecture SY
4 p.m.
M8 Tutorial on CQA Prediction Tutorial NS/SY

Day 2 (May 28)
8 a.m.
M9 DOE Concepts Lecture SY    
9 a.m.
M10 Modeling, Optimization and Validation  Lecture NS
10 a.m.
M11 Tutorial on Modeling Building with Media/CQA Tutorial NS/SY
11 a.m.
M12 Tutorial on Robustness and Design Space Tutorial NS/SY
Noon
Lunch
1 p.m.
M13 Design Space Lecture SY
2 p.m.
M14 Tutorial on Design Space Building Tutorial NS/SY
3 p.m.
M15 CQA Specification Lecture NS
4 p.m.
M16 Tutorial on CQA Specification Tutorial NS/SY

Part II. BPQC Business Meeting and Reception

May 28, 2014 (Wednesday), 1 a.m. - 6:30 a.m.
1 p.m.
Business meeting with consortium member companies For appointment, RSVP (bpqc@uml.edu or seongkyu_yoon@uml.edu, 978-934-4741)
6:30 p.m.
RECEPTION (Trainees, BPQC members and all workshop participants are invited)

Part III. Workshop

May 29, 2014 (Thursday), 8 a.m. – 5 a.m.
8 a.m.
REGISTRATION
8:30 a.m.
WELCOME and INTRODUCTION (UMass Lowell and organizer)
8:40 a.m.

PAT/QbD, Motivation and Different Perspectives

Morning Session Chair: Dr. Thomas Ryll, Sr. Director of Cell-Culture Development, Biogen Idec (8:40–8:50)

PLENARY PRESENTATION: Dr. Christine Moore, FDA/CDER, Program Director (8:50-9:30)

"Application of PAT to support QbD in Bioprocessing" Steve Hammond, Ph.D., Sr. Director of Process Analytical Sciences (9:30-10)
10 a.m.
BREAK
10:20 a.m.

"Real-time cell culture control in a integrated benchtop platform: implications for research" Jean-Francois P Hamel, Ph.D., MIT/Chem Engineering (10:20-10:50)

"Title TBD" Michael Tarlov, Ph.D., Chief, Biomolecular Measurement Division, NIST (10:50-11:20)

PANEL DISCUSSION (11:20–12)

Panelists: Dr. Ryll (BiogenIdec) and Speakers


Noon
NETWORKING LUNCH
1 p.m.

PAT Challenges and Practices

Afternoon Session Chair: Michael Tarlov, Ph.D., Chief, Biomolecular Measurement Division, NIST (1:00–1:10)

PLENARY PRESENTATION 2: "PAT, Future of Biotechnology" Kurt Brorson, Ph.D., Head, Division of Monoclonal Antibodies, FDA/CDER (1:10-1:50)

"QbD Based Development Strategies for Antibodies - A Case Study in Biosimilar Develop.m.ent" Dr. Kumar Dhanasekharen, Director of Process Develop.m.ent, Cook Pharmicca, (1:50-2:20)

"Biologics Advanced Process Control at BiogenIdec" LiLong Huang, Ph.D., Sr. Engineeting, Manufacturing Sciences, BiogenIdec(2:20-2:50)

2:50 p.m.
BREAK
3:20 p.m.

"Perspective in QbD in Drug development and Manufacturing" Bert Frohlich, Ph.D., Director of Bioengineering, Shire (3:20-3:50)

"Using QbD and PAT to Develop Adaptive Manufacturing Processes" Jose Gomes, Ph.D., Principal Engineer, Pfizer (3:50-4:20)

PANEL DISCUSSION (4:20–5)

Panelists: Michael Tarlov and Speakers

5 p.m.
RECEPTION AND NETWORKING POSTER SESSION
20-30 posters will be prepared

May 30 (Friday), 8 a.m. - 5 a.m.
8 a.m.
REGISTRATION
8:30 a.m.

QbD Challenges and Practices

Morning Session Chair: Dr. Jack Prior, Sr. Director of Manufacturing Sciences and Technology, Genzyme (8:30-8:40)

"QbD in Drug Product Formulation" Andrew Cowen, CEO of Biopharmaceutical Technology (UK) (8:40-9:10)

"How to knit Risk, Design Space and Control Strategy" Sun Kim, Ph.D., Sr. Manager of Quality Systems, Bayer, Risk Assessment 2.0 for QbD (9:10-9:40)

"Raman spectroscopy applied to monitoring, modeling and control of biologics production" John-Paul Smelko, Sr. Engineer, Cell-Culture Develop.m.ent, BiogenIdec,(9:40-10:10)

"QbD in Continuous mAb production" Tim Johnson, Ph.D., Associate Director, Commercial Cell-Culture develop.m.ent (10:10-10:40)

10:50 a.m.

Biopharmaceutical Consortium Session - Driving for Future

Consortium Faculty, Research Update (4 Consortium Faculty)

Consortium Graduate Research Update (3-4 Graduate Students)

Consortium Update (Seongkyu Yoon, Ph.D.)

Noon NETWORKING LUNCH
1 p.m.

PAT/QbD Path-forward Afternoon Session Chair: Dr. Kevin Bittorf, VP of LivingProof Inc.(1:00 – 1:10 p.m.) 

"Systems Technology in Biologics QbD Implementation" Richard Braatz, Ph.D., Professor, Chemical Engineering, MIT (1:10-1:40)

"Title TBA"  Erik Read, Ph.D., Principal Scientist, Divison of Monoclonal Antibodies, CDER/FDA (1:40-2:10)

"Understanding the effects of process conditions on protein glycolysation and proteglycan synthesis" Susan Sharfstein, Ph.D., Associate Professor, Chemical Engineering, SUNY Albany (2:10-2:30) 

"QbD in Continuous Manufacturing of mAb" Maurizio Cattaneo, Ph.D., CEO of Biovoutions (2:30-3:00 p.m.)

PANEL DISCUSSION (3:00-3:30 p.m.) Panelists: TBD

3:30 p.m. CLOSING REMARKS

For questions please contact: bpqc@uml.edu, or Seongkyu_Yoon@uml.edu, 978-934-4741.