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

BPQC 2016

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

  1. Discount for academia: 50% for faculty, 80% for student and postdoctoral researchers
  2. Ending March 31, Early-Bird Registration.  Get an additional 10% discount!  After Early-Bird registration, no further discount for academic participants will be offered.
  3. 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

Notes: CM: Chris McCready (MKS Data Analytics Solutions); SY: Seongkyu Yoon (UML)

 

For any questions about the Biomanufacturing Summit 2016, please contact: BPQC@uml.edu, or Seongkyu Yoon (Seongkyu_yoon@uml.edu; 978-934-4741)

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