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 p.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 a.m. M5 Batch Level Modeling I Lecture NS
2 a.m.

M6 Tutorial on Raw material and CC impact on CQA

Tutorial NS/SY
3 a.m. M7 Batch Level Modeling II Lecture SY
4 a.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
12 a.m. Lunch
1 a.m. M13 Design Space Lecture SY
2 a.m. M14 Tutorial on Design Space Building Tutorial NS/SY
3 a.m. M15 CQA Specification Lecture NS
4 a.m. M16 Tutorial on CQA Specification Tutorial NS/SY

Part II. BPQC Business Meeting and Reception

May 28, 2014 (Wednesday), 1 p.m. - 6:30 p.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 p.m.

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

PAT/QbD 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)

Session I Talk 1 (9:30-10)
10 a.m. BREAK
10:20 a.m.

Session I Talk 2 (10:20-10:50)

Session I Talk 3 (10:50-11:20)

PANEL DISCUSSION (11:20–12)

Panelists: Dr. Ryll (BiogenIdec)


12 p.m. NETWORKING LUNCH
1 p.m.

PAT Challenges and Practices

Afternoon Session Chair: Dr. Jack Prior, Sr. Director of Manufacturing Sciences and Technology, Genzyme (1–1:10)

PLENARY PRESENTATION 2 (1:10-1:50)

Session II Talk 1 (1:50-2:20)

Session II Talk 2 (2:20-2:50)

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

Session II Talk 3 (3:20-3:50)

Session II Talk 4 (3:50-4:20)

PANEL DISCUSSION (4:20–5)

Panelists: Dr. Prior (Genzyme)

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

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

QbD Challenges and Practices

Morning Session Chair: TBD (8:30-8:40)

Session III Talk 1 (8:40-9:10)

Session III Talk 2 (9:10-9:40)

Session III Talk 3 (9:40-10:10)

10:10 a.m. NETWORKING BREAK
10:40 a.m.

Session III Talk 4 (10:40-11:20)

Session III Talk 5 (11:20-11:50)

PANEL DISCUSSION (11:20–12)

Panelists: TBD

12 p.m. NETWORKING LUNCH
1 p.m.

PAT/QbD Path-forward Afternoon Session Chair:  TBD (1 – 1:10 PM) 

Session IV Talk 1  (1:10-1:40)

Session IV Talk 2  (1:40-2:10)

Session IV Talk 3  (2:10-2:30) 

PANEL DISCUSSION (2:30–3) Panelists: TBD

3 p.m. CLOSING REMARKS


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