QbD Workshop at Biomanufacturing Summit, May 23-24, 2016 at UMass Lowell

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For those implementing QbD in biologics, join us in May at University of Massachusetts.

Agenda and registration are as follows:

QbD Risk Assessment & Design Space Workshop:

May 18-20 2016: Wednesday – Thursday, 8:00AM – 5:00PM; Friday 8:00AM – 12:00PM

Biomanufacturing Summit, May 23-24, 2016 at UMass Lowell

May 23-24, 2016: Workshop on “Future Biomanufacturing”

May 18-20, 2016: Advanced Training on Integrated Continuous Biomanufacturing

May 18-20, 2016: Advanced Training on QbD Risk Assessment and Design Space

May 25-27, 2016: Advanced Training on PAT and QbD Principles in Biopharmaceuticals

Location: Inn & Conference Center, University of Massachusetts Lowell, Lowell, MA

Hosted by Biomanufacturing Science and Technology Consortium (BSTC), Massachusetts BioManufacturing Center (MBMC), University of Massachusetts Lowell

Summit Theme: Future Biomanufacturing

Session 1. Cell & Gene Therapeutics, Vaccine
Session 2. Protein Therapeutics – USP & Analytical
Session 3. Regulatory Sciences, Standardization and Workforce Development
Session 4. Protein Therapeutics – DSP & Formulation

In addition, the following areas of interest will be discussed:

Emerging Technology and New Therapeutics
Regulatory Sciences and Standardization
Industry Practices and New Trends in PAT, QbD, Quality Metrics, and Process Validation
Integrated Continuous Manufacturing
Systems, Synthetic Biology in Biomanufacturing

Who will be participating?

Biomanufacturing Summit 2016 will mark the 5th annual event of the Biomanufacturing Science and Technology Consortium (BSTC). Expected Summit participants are scientists and engineers including biopharmaceutical manufacturers, technology/system providers, raw material suppliers and agencies in the areas of development, manufacturing, and engineering. Our objective is for professionals and leaders of the biopharmaceutical industry to get together

to talk about future biomanufacturing challenges and breakthrough technology. The Summit will also offer the opportunity to network with professionals from major biopharmaceutical manufacturers and a variety of technology providers such as Biogen Idec, Genzyme, Pfizer, Momenta, Millipore, BMS, GE, SAFC, and many more!

Plenary Speakers

Tim Charlebois, Ph.D., VP of Technology Innovation at Pfizer

Larry Lee, Ph.D., Acting Director, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Immediate Office

Session Speakers

Siddharth Gupta, Cell Therapeutics Scientist, Lonza Biologics

Krishnendu Roy, Ph.D., Professor of Biomedical Engineering, Georgia Tech

Barbara Thorne, Ph.D., Gene Therapy Consultant

David Knop, Ph.D., Executive Director, AGTC

Sadettin Ozturk, Ph.D., Deputy Director of Process Development, Mass Biologics

Michael J. Betenbaugh, Ph.D., Professor of Chemical Engineering, Johns Hopkins Univ

Anthony Sinskey, Ph.D., Professor of Biology, MIT

Alex Lazar, Ph.D., Head of Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

John C. Gebler, Ph.D., Director of Biopharma Business Development, Waters Corp

Patrick Swann, Ph.D., Senior Director, Biogen, Inc.

Wei-Shou Hu, Ph.D., Professor of Chemical Engineering, Univ of Minnesota Twin Cities

Rajesh Beri, Ph.D., Director and BPOG committee, Lonza Biologics

Michael J. Tarlov, Ph.D., Chief, Biomolecular Measurement Division, NIST

Jean Hu-Primmer, Ph.D., Health scientist and project officer, OS/ASPR/BARDA

Kamal Rashid, Ph.D., Director, Biomanufacturing Education & Training Center, WPI

M. Nazmul Karim, Ph.D., Professor of Chemical Engineering, Texas A&M University

Abraham Lenhoff, Ph.D., Professor of Chemical Engineering, Univ of Delaware

Rachel Barrett, Ph.D., Director, Biophysics, Boehringer Ingelheim

Steve Cramer, Ph.D., Professor of Chemical Engineering, RPI

Ruben Carbonell, Ph.D., Professor of Chemical Engineering, North Carolina State University

Michael Phillips, Ph.D., Director, Bioprocess Development, EMD Millipore

Robert S. Gronke, Ph.D., Senior Principal Scientist, Biogen Inc.

Join us after the workshop for a reception and poster session featuring research by biomanufacturing consortium scientists!

Registration

To register, you can register on-line or e-mail BPQC@uml.edu, being sure to provide your contact information (name, company, title, e-mail address, and phone number).

Regular registration fees:

Workshop only: $300

Training only: $1850

Workshop + 1 training session: $1900

Workshop + 2 training sessions: $3600

Get your 10% discount by registering by March 31:

Workshop only: $270

Training only: $1665

Workshop + 1 training session: $1710

Workshop + 2 training sessions: $3240

Notes

Discount for academia: 50% for faculty, 80% for student and postdoctoral researchers
Ending March 31, Early-Bird Registration. Get an additional 10% discount! After Early-Bird registration, no further discount for academic participants will be offered.
No refunds for cancellation will be provided after April 30.

Accommodations

We have reserved a limited number of rooms at the ICC (Inn & Conference Center) for Summit attendees. When making your reservation, please mention that you are attending Biomanufacturing Summit 2016 to get your special rate, or to book online copy and paste this link into your browser: https://bookings.ihotelier.com/UMass-Lowell-Inn-and-Conference-Center/bookings.jsp?hotelID=73933&groupID=1605520

Summit Chairs:

Anurag Khetan, Ph.D., Site Director, Process Development, BMS (Industry Chair)

Kelvin Lee, Ph.D., Prof of Chemical Engineering, Univ of Delaware (Academic Chair)

Organization Committee:

Seongkyu Yoon, Ph.D., Assistant Professor of Chemical Engineering, UMass Lowell

Arlene Parquette, Director of Business Development, UMass Lowell

Michael Tith, Director of Foundation Relations, UMass Lowell

Carl Lawton, Ph.D., Associate Professor of Chemical Engineering, UMass Lowell

Jin Xu, Ph.D., Associate Professor of Chemistry, UMass Lowell

Hyunmin Yi, Ph.D., Associate Professor of Chemical and Biological Engineering, Tufts

Sadettin Ozturk, Ph.D., Mass Biologics, UMass Medical School, Head of Development and Analytical Technology

Industry Advisory Board:

(For questions about the industry advisory board, please contact BPQC@uml.edu)

Rajesh Beri, Ph.D., Head, Mammalian Manufacturing R&D, Lonza Biologics, Portsmouth, NH (Chair)

Rashmi Kshirsagar, Ph.D., Director of Cell Culture Development, Biogen, Inc.

Thomas Ryll, Ph.D., VP, ImmunoGen

Jack Prior, Sc.D., Sr. Director of Bioprocess Engineering, Genzyme

Tom Porter, Ph.D., Sr. Director of Analytical Research & Development, Global Biologics, Pfizer

SPONSORSHIP

(To become a sponsor or for questions about sponsorship, please contact BPQC@uml.edu)

Platinum Sponsorship (US $4,000)

The sponsoring company can have a venue choice of either luncheon or reception. Four complimentary passes to the workshop will be provided. Signs with company name and logo will be placed throughout sponsored events. The company can display a pop-up banner if available. A company flyer (provided by sponsor) will be included with the conference registration packet. Company logo will be in the conference brochure and booklet. Special recognition will be made during the conference.

Gold Sponsorship (US $3,000)

The sponsoring company can have a venue choice of breakfast, morning or afternoon break. Three complimentary passes to the workshop will be provided. Signs with company name and logo will be placed throughout sponsored events. The company can display a pop-up banner if available. A company flyer (provided by sponsor) will be included with conference registration packet. Company logo will be in the conference brochure and booklet. Special recognition will be made during the conference.

Sponsors

Consortium Marketing Partner

IBC Life Sciences

Massachusetts Life Science Center

MassBio

Biomanufacturing Summit, May 23-24, 2016 at UMass Lowell

May 23-24, 2016: Workshop on “Future Biomanufacturing”

May 18-20, 2016: Advanced Training on PAT and QbD Principles in Biopharmaceuticals

May 18-20, 2016: Advanced Training on QbD Risk Assessment and Design Space

May 25-27, 2016: Advanced Training on Integrated Continuous Biomanufacturing

Location: Inn & Conference Center, University of Massachusetts Lowell, Lowell, MA

Hosted by Biomanufacturing Science and Technology Consortium (BSTC), Massachusetts BioManufacturing Center (MBMC), University of Massachusetts Lowell

Part I. Advanced Training on Integrated Continuous Biomanufacturing

May 18-20 2016: Wednesday – Thursday, 8:00AM – 5:00PM; Friday 8:00AM – 12:00PM

Module #	Description		Type		Instructor
Day 1	ICB 1
8:00 AM	Introduction	Lecture
8:10AM	M1: Bioprocess General	Lecture		Prof. Carl Lawton
10:00 AM	M2: USP Technology & Practices	Lecture		Dr. Sadettin Ozturk
12:00 PM	Lunch
1:00 PM	M3: DSP Technology & Practices	Lecture		TBD
3:00 PM	M4: ICB – Case Study 1, Biovolutions	Lecture		Dr. Maurizio Catteneo
Day 2	ICB 2
8:00 AM	M5. ICB – Case Study 2			TBD
10:00 AM	M6, ICB, Case Study – Integrated Control	Lecture		PBS Biotech
12:00 PM	Lunch
1:00 PM	M7, Commercial Technology – ATF	Lecture		TBD
3:00 PM	M8, Commercial Technology – SMB & PCC	Lecture		TBD
Day 3	ICB 3
8:00 AM	M9, ICB, Systems Technology	Lecture		Seongkyu Yoon
10:00 AM	M10, Regulatory aspect and commercialization	Lecture		TBD

Invited instructor:

Genzyme (Veena),

Biogen (John Piracci)

PBS Biotech (Daniel)

ATF (Sherry)

Lewa (Kathleen)

FDA, Pfizer

Part II. Advanced Training on QbD Risk Assessment and DS Implementation

May 18-20 2016: Wednesday – Thursday, 8:00AM – 5:00PM; Friday 8:00AM – 12:00PM

Module #	Description	Type	Instructor
Day 1	QbD Risk Assessment & DS Implementation
8:00 AM	Introduction	Lecture
8:10AM	M1. QbD Risk Assessment Introduction	Lecture	SK
9:00 AM	M2. QbD/DS Implementation Introduction	Lecture	SY
10:00 AM	M3. QbD RA Tool Introduction	Lecture	SK
11:00 AM	M4. QbD/DS Tool Introduction	Lecture	SY
12:00 PM	QbD Risk Assessment I
1:00 PM	M5. QbD 1st Steps I	Lecture	SK
2:00 PM	M6. QbD 1st Steps II	Lecture	SK
3:00 PM	M7. Lean QbD I	Lecture	SK
4:00 PM	M8. Lean QbD II	Lecture	SK
Day 2	QbD Risk Assessment 2
8:00 AM	M9. Case Study I	Lecture	SK
9:00 AM	M10. Case Study 2	Lecture	SK
10:00 AM	M11. Case Study II	Lecture	SK
11:00 AM	M12. Case Study II	Lecture	SK
12:00 PM	DS 1
1:00 PM	M13. Design Space Concepts	Lecture	SY
2:00 PM	M14. Design Space Building	Lecture	SY
3:00 PM	M15. Design Space Case Study 1	Lecture	SY
4:00 PM	M16. Design Space Case Study 2	Lecture	SY
Day 3	DS 2
8:00 AM	M17. Process Optimization	Lecture	SY
9:00 AM	M18. Setpoint Analysis	Lecture	SY
10:00 AM	M19. CQA Spec Setting	Lecture	SY
11:00 AM	M20. Design Space Challenges	Lecture	SY

SK: Dr. Sun Kim (QbDWorks LLC), SY: Seongkyu Yoon (UML)

Part III. Workshop

May 23: Monday, 8:00AM – 5:30PM

7:00	REGISTRATION
8:00	WELCOME AND INTRODUCTION
8:10	Session I: Cell & Gene-therapeutics	Rashmi Kshirsagar, Ph.D., Director, Cell Culture Development, Biogen, Inc.
8:15	PLENARY PRESENTATION	Timothy Charlebois, Ph.D., VP, Technology Innovation at Pfizer
9:00		Siddharth Gupta, Cell Therapeutics Scientist, Lonza Biologics
9:30		Krishnendu Roy, Ph.D., Professor of Biomedical Engineering, Georgia Tech
10:00	BREAK
10:30		Barbara Thorne, Ph.D., Gene Therapy Consultant
11:00		David Knop, Ph.D., Executive Director, AGTC
11:30		Sadettin Ozturk, Ph.D., Deputy Director of Process Development, Mass Biologics
12:00	NETWORKING LUNCH
1:25	Session II: Protein therapeutics – USP & Analytical	Neha Shah, Ph.D., Senior Scientist, Commercial process development, Genzyme Chris Hwang, Ph.D., Senior Director, Technology Development, Genzyme
1:30		Michael J. Betenbaugh, Ph.D., Professor of Chemical Engineering, Johns Hopkins University
2:00		Anthony Sinskey, Ph.D., Professor of Biology, MIT
2:30	Analytical Methods Used in Support of Process Development of Antibody-Drug Conjugates (ADCs)	Alex Lazar, Ph.D., Head of Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.
3:00	BREAK
3:30	Liquid Chromatography (LC) and Mass Spectrometry (MS) Technologies for the Characterization of New Biologic Therapeutics	John C. Gebler, Ph.D., Director of Biopharma Business Development, Waters Corp
4:00	Application of Advanced Analytics to Support Advanced Process Controls	Patrick Swann, Ph.D., Senior Director, Biogen, Inc.
4:30		Wei-Shou Hu, Ph.D., Professor of Chemical Engineering, University of Minnesota Twin Cities

May 24: Tuesday, 8:00AM – 5:00PM

7:00	REGISTRATION
8:00	Session III: Regulatory Sciences, Standardization and Workforce Development	Kelvin Lee, Ph.D., Professor of Chemical Engineering, University of Delaware
8:15	PLENARY PRESENTATION: Advancing Biomanufacturing: Challenges and Opportunities	Larry Lee, Acting Director of OGD/CDER/FDA
8:50		Rajesh Beri, Ph.D., Director and BPOG committee, Lonza Biologics
9:20	The Role of Standards in the Development and Manufacturing of Protein Biologics	Michael J. Tarlov, Ph.D., Chief, Biomolecular Measurement Division, NIST
9:50	BREAK
10:20		Jean Hu-Primmer, Ph.D., Health scientist and project officer, OS/ASPR/BARDA
10:50		Kamal Rashid, Ph.D., Director, Biomanufacturing Education & Training Center, WPI
11:20		M. Nazmul Karim, Ph.D., Professor of Chemical Engineering, Texas A&M University
11:50	NETWORKING LUNCH
1:15	Session IV: Protein therapeutics – DSP & Formulation	Anurag Khetan, Ph.D., Site Director, Process Development, Bristol-Myers Squibb
1:20		Abraham Lenhoff, Ph.D., Professor of Chemical Engineering, University of Delaware
1:50		Rachel Barrett, Ph.D., Director, Biophysics, Boehringer Ingelheim
2:20		Steve Cramer, Ph.D., Professor of Chemical Engineering, RPI
2:50	BREAK
3:20		Ruben Carbonell, Ph.D., Professor of Chemical Engineering, North Carolina State University
3:50		Michael Phillips, Ph.D., Director, Bioprocess Development, EMD Millipore
4:20	Improving the Downstream mAb Platform: Keeping Up with the Changing Times	Robert S. Gronke, Ph.D. Senior Principal Scientist, Biogen, Inc.
4:50	CLOSING REMARKS
5:00	RECEPTION AND NETWORKING POSTER SESSION

Part IV. BPQC Business Meeting and Reception

May 25: Wednesday, 9:00AM – 4:00PM

9:00 AM

(Location TBD)

Business meeting with consortium member companies. For appointment, contact Dr. Seongkyu Yoon (seongkyu_yoon@uml.edu, 978-934-4741)

Part V. Advanced Training on PAT/QbD in Biopharmaceuticals

May 25-27 2016: Wednesday – Thursday, 8:00AM – 5:00PM; Friday 8:00AM – 12:00PM

Module #	Description	Type	Instructor
Day 1	Multivariate Data Analysis
M1, 8AM	MVDA Introduction	Lecture	CM
M2, 9AM	Principal Component Analysis & Application	Lecture/Tutorial	CM
M3, 10AM	Partial Least Squares, Review	Lecture	CM
M4, 11AM	Tutorial on Partial Least Squares	Tutorial	CM
12PM	Lunch
M5, 1PM	Batch Modeling Introduction	Lecture	CM
M6, 2PM	Batch Modeling Application	Lecture	CM /SY
M7, 3PM	Batch Evolution Modeling I & Tutorial	Lecture/Tutorial	CM /SY
M8, 4PM	Batch Evolution Modeling II & Tutorial	Lecture/Tutorial	CM /SY
Day 2	Batch Modeling & DOE
M9, 8AM	Batch Level Modeling I	Lecture	SY / CM
M10, 9AM	Batch Level Modeling II & Tutorial	Lecture/Tutorial	SY/ CM
M11, 10AM	Tutorial on Raw Material and CC Impact on CQA	Tutorial	SY
M12, 11AM	Tutorial on CQA Prediction	Tutorial	SY
12PM	Lunch
M13, 1PM	DOE Concepts	Lecture	SY/ CM
M14, 2PM	DOE FF & Analysis & Tutorial	Lecture/Tutorial	SY
M15, 3PM	DOE Screening	Lecture	SY/ CM
M16, 4PM	DOE Optimization & Tutorial	Lecture/Tutorial	SY
Day 3	QbD and Design Space Assessment
M17, 8AM	DOE Robustness	Lecture	SY/ CM
M18, 9AM	DOE Design Space	Lecture	CM /SY
M19, 10AM	DOE Design Space Exploration	Lecture	SY
M20, 11AM	DOE Design Space Tutorial	Tutorial	SY