Presentations

Listed below in the tables are the approved for release presentations at the 2014 BPQC Summit in the PDF file format.

Also included are the presentation posters that have been approved for release. 

Attendee List (pdf)

May 29 Workshop

• M1
  "Challenges and Opportunities for Continuous Pharmaceutical Manufacturing in QbD framework  (pdf)
  Dr. Christine Moore, Program Director of FDA/CDER
• M2
  "Application of PAT to support QbD in Bioprocessing"  (pdf)
  Jeff Doyle, Manager of Process Analytics Sciences
• M3
  "Real-time cell culture control in an integrated benchtop platform: implications for research" (pdf)
  Jean-Francois P Hamel, MIT/Chem Engineering
• M4
  "Improved Measurements and Standards to Support the Development of Protein Therapeutics" (pdf)
  Michael Tarlov, Ph.D., Chief, Biomolecular Measurement Division, NIST
• A1
  "PAT, Future of Biotechnology"  (pdf)
  Kurt Brorson, Ph.D., Head, Division of Monoclonal Antibody, FDA/CDER
• A2
  "Rapid Development and Scale-up of Therapeutic Antibodies - A QbD Perspective with a Case Study for a Biosimilar Trastuzumab"  (pdf)
  Kumar Dhanasekharan, Ph.D., Director of Process Development, Cook Pharmica LLC
• A4
  "Perspective in QbD in Drug development and Manufacturing"  (pdf)
  Bert Frohlich, Ph.D., Director of Bioengineering, Shire
• A6
  "Development application and single use probes for building Design Space of live cell concentration by dielectric spectroscopy"  (pdf)
  John Carvell, Ph.D., Managing Director, Aber Instruments

May 30 Workshop

• M1
  "QbD in Drug Product Formulation"  (pdf)
  Andrew Cowen, CEO of Biopharma Technology Ltd.
• M2
  "Exploring the linkage between cell culture and downstream processing via statistical design" (pdf)
  Erik Read, Ph.D., Principal Scientist, Division of Monoclonal Antibody, CDER/FDA
• M3
  "Raman spectroscopy applied to monitoring, modeling and control of biologics production"  (pdf)
  John-Paul Smelko, Sr. Engineer, Cell-Culture Development, BiogenIdec
• F1
  Consortium Faculty - Carl Lawton (pdf)
• F2
  Consortium Faculty - Jin Xu (pdf)
• F3
  Consortium Faculty - Hyunmin Yi (pdf)
• F4
  MassBiologics Labs (pdf)
  
• F5
  Consortium Faculty - Seongkyu Yoon (pdf)
• F6
  Core Research Facility and Cleanroom Facility (pdf)
• F7
  Graduate Student Presentations (pdf)
• A1
  "Systems Technology in Biologics QbD Implementation" (pdf)
  Richard Braatz, Ph.D., Professor, Chemical Engineering, MIT
• A2
  "Regulatory Perspective on Implementation of MSPC for Pharmaceutical Manufacturing" (pdf)
  Bogdan Kurtyka, Ph.D., Review Chemist, FDA/CDER/ONDQA
• A3
  "Understanding the effects of process conditions on protein glycosylation and proteoglycan synthesis" (pdf)
  Susan Sharfstein, Ph.D., Associate Professor, Chemical Engineering, SUNY Albany
  
• A4
  "QbD in Continuous Manufacturing of mAb" (pdf)
  Maurizio Cattaneo, Ph.D., CEO of Bivolutions>

Posters

• Novel Strategy for Media Formulation Development (pdf)
  Hemlata Hemlata and Seongkyu Yoon, University of Massachusetts Lowell
• Multi-variate data Analysis for Protein A chromatography column (pdf)
  Ketki Behere, Rachel Wollacott, and Seongkyu Yoon, University of Massachusetts Lowell, MassBiologic
• Glycosylation Reaction Network Models (pdf)
  Sha Sha and Seongkyu Yoon, University of Massachusetts Lowell
• A Calibration-free Application of Near Infrared Spectroscopy to the Determination of Viable Cell Density in Mammalian Cells (pdf)
  Zhuangrong Huang and Seongkyu Yoon, University of Massachusetts Lowell
• Metabolomics for CHO-culture production (pdf)
  Seoyoung Park and Seongkyu Yoon, University of Massachusetts Lowell
• Effect of Media on Cellular Metabolism (pdf)
  Thomas Reimonn and Seongkyu Yoon, University of Massachusetts Lowell
• The Hunt for MRI - A Novel Method to Automate and Control Bioreactor and Fermentor Feeding (pdf)
  Greg Emmerson, Sam Watts (Stratophase Ltd, Romsey, Hanpshire, UK), George Barringer, (Stratophase, Groton, MA, USA)
• Morphological Observations Using Image Cytometry for the Comparison of Trypan Blue and Fluorescence-based Cellular Viability (pdf)
  Leo L. Chan, Dmitry Kuksin, Daniel Laverty, Jean Qiu, and Bo Lin, Department of Technology R&D, Nexcelom Bioscience LLC, Lawrence, MA 01843
• Rapid Image Cytometry Method for Measuring Concentration and Viability of Primary Cells used in Cellular Therapy (pdf)
  Leo L. Chan, James Leeb, Dmitry Kuksin, and Jean Qiu, Department of Technology R&D, Nexcelom Bioscience LLC, Lawrence, MA 01843, bAllCells, LLC, Alameda, CA 94502
• Automation Method to Increase Efficiency in Cell Line Development (pdf)
  Sarah Kessela, Oliver Derya, Leo L. Chana, Dmitry Kuksina, and Jean Qiu, Department of Technology R&D, Nexcelom Bioscience LLC, Lawrence, MA 01843
• Cell Line Qualifying Attributes for Prediction of Good Producers (pdf)
  Alessandro Mora, University of Massachusetts Lowell
• Facile Biomolecular Conjugation with Chitosan-Poly(ethylene glycol) Microparticles via Strain-Promoted Alkyne-Azide Cycloaddition Reaction toward Rapid Bioprocess Monitoring Applications (pdf)
  Sukwon Jung and Hyunmin Yi, Department of Chemical and Biological Engineering, Tufts University
• Evaluation of PBS 15 Air-Wheel Single Use Bioreactor for a Fed-Batch Monoclonal Antibody Process (pdf)
  Tuhina Bhattacharya, Sadettin Ozturk, UMass Biologics, UMass Medical school, Worcestor, MA
• Bacteria Fermentation: Identifying Critical Components of Peptone Fermentation Media (pdf)
  Felice de Jong, Clarence Gillett, Chris Beecher, IROA Technologies LLC