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Advances in Large Scale BioManufacturing and Scale-Up Production, 2nd ED

BioPlan Associates, Inc.
November 1, 2007
1220 Pages - SKU: DFAQ1627671

Abstract Table of Contents Related Reports

A Comprehensive Study of the Science, Technology and Business of Biopharmaceutical Manufacturing. This new ASM study provides a clear view of what the industry perceives to be the future of biopharmaceutical manufacturing.

Chapter 1: Frontiers in Bioprocessing: 2007; K. John Morrow, Jr., Ph.D.
Chapter 2: The Science for Biogenerics: Are We; There Already?; Theresa L. Gerrard, Ph.D.
Technology Processes
Chapter 3: Maximizing Productivity in Biopharmaceutical; Manufacturing; Matthew D. Hilton, Ph.D. and Parviz A. Shamlou, Ph.D.
Chapter 4: Increasing Performance of Mammalian; Expression Platforms; Trent Carrier, Ph.D. and Mugdha Gadgil, Ph.D.
Chapter 5: Cell Line Engineering and Development:; Case Studies; Thomas Primiano, Ph.D., Morris Rosenberg, Ph.D., Danika Goosney, Ph.D.,; Harry C. Ledebur, Jr., Ph.D., and Nicholas C. Nicolaides, Ph.D.; emerging Technologies
Chapter 6: Design of Large-Scale Cell Culture Process —; A Process Engineering Point of View; Wei Huang, Chun-Ko Jin, Tony Cope, Megan Jakobsen,; Jennifer Foelske, Kelly Kivett, Teresa Cheung, and Greg Francis
Chapter 7: Challenges in Biopharmaceutical; Scale-up to Production; Beth Junker, Ph.D.
Chapter 8: Large-Scale Microbial Production Technology for; Human Therapeutic Products; Xiaoming Yang, Ph.D.
Chapter 9: Microbiological Methods in Support; of Manufacturing; Scott Sutton and Jeanne Moldenhauer
Chapter 10: Initial Protein Recovery Process: Purification; Methods for Pilot and Mid-Scale Processes,; Their Advantages and Disadvantages; Joseph Shiloach, Jeanne B. Kaufman, and Loc B. Trinh
Chapter 11: The Scaling Up of Fermentation and Primary Recovery; Processes of Soluble Protein Antigens Used as Vaccine; Candidates Against Infectious Diseases; Timothy S. Lee, Ph.D.
Chapter 12: Scale-up of Saccharomyces cerevisiae; Fermentation for the Manufacture of Recombinant; Human Albumin; Ashley Wigley, Diane Wilkinson, Ph.D., Dave Mead, Ph.D., and Roger Freestone
Chapter 13: Good Automation Manufacturing Practice (GAMP); in Large Scale Biopharmaceutical Production; Beth Junker Ph.D., Jens Christensen, Paul Kardos, W. Smizaski, and T. Brix
Chapter 14: Advances in Improved Expression of Recombinant; Proteins in Microbial Systems; Daniel Rudolph, Ph.D., Sriram Srinivasan, Ph.D., Don R. Durham, Ph.D.,; and Aaron Heifetz, Ph.D.
Chapter 15: Design of Large-Scale Cell Culture Process —; A Process Engineering Point of View; Chun-Ko Jin, Tony Cope, Megan Jakobsen, Jennifer Foelske, Kelly Kivett,; Teresa Cheung, and Greg Francis
Chapter 16: Protein Stability, Solubility And Solute Interactions for; Manufacturing Process Development; Brent S. Kendrick, Ph.D.
Chapter 17: Launching New Biologics: A Process and Facility; Design Approach; Trent Carrier, Ph.D., Marshall Gayton, Joye L. Bramble, Ph.D., and; Abraham Shamir, Ph.D.
Disposable Technologies
Chapter 18: Disposable Technologies for Manufacturing; of Biologics; Vladimir Kostyukovsky
Biobrief 1: Impact of Disposable Technology on; Biopharmaceutical Manufacturing; Merlin Goldman, Ph.D.
Chapter 19: Managing Large Volume, Single Use Disposables in; Biopharmaceutical Manufacturing; Louis Martin, Malcolm Bartow, Bill Schaidle, Gene Tuttle, and Craig Sandstrom
Biobrief 2: Cleaning vs Dedicated or Disposable Equipment for; Pharmaceutical Production; J-M. Cardot and E. Beyssac
Downstream Processes
Chapter 20: Optimization of Antibody Processing: Upstream and; Downstream; Joe X. Zhou, Ph.D., Tim Tressel, Ph.D.,Tony Hong, Feng Li, Ph.D., Xiaoming Yang,; Ph.D., and Brian Lee, Ph.D.
Chapter 21: Simulated Moving Bed Chromatography —; A Promising Alternative for the Purification of; BioPharmaceuticals; Dr. Kathleen Mihlbachler, Ph.D.
Chapter 22: Implementation of Membrane Technology in; Antibody Large-Scale Purification; Joe X. Zhou, Ph.D., and Tim Tressel, Ph.D.
Chapter 23: Development of Viral Clearance Strategies for; Large-Scale Monoclonal Antibody Production; Joe X Zhou, Ph.D., and Houman Dehghani, Ph.D.
Biobrief 3: Multicolumn Countercurrent Solvent Gradient; Purification of Biomolecules (MCSGP); Lars Aumann, Thomas Müller-Späth, Guido Ströhlein, and Massimo Morbidelli
Chapter 24: Downstream Processing: Removing Economic and; Technical Bottlenecks; Uwe Gottschalk, Ph.D.
Chapter 25: Purification of Monoclonal and Genetically; Engineered Antibodies; Robert M. Kennedy, Ph.D.
Regulatory Issues
Chapter 26: Regulatory Environment for Follow-on Biologics; James W. Precup, Renee D. Schantz-Shirley, Josephine Secnik,; and John K. Towns
Chapter 27: Post-Approval Changes for Large Scale; Biopharmaceutical Manufacturing: Global; Regulatory Issues; John J. Dougherty, James W. Precup, Josephine Secnik, and John K. Towns
Chapter 28: FDA and Regulatory Issues in Biopharmaceutical; Manufacturing; Andrea E. Chamblee, Esq., RAC
Business & Legal Aspects
Chapter 29: Strategic Issues: Capital Investments; Jeffery N. Odum
Biobrief 4: Disposable “Tubing Assemblies” in; Biopharmaceutical Manufacturing; Carl Martin
Chapter 30: Pricing Issues for Biotechnology Products; William Lobb, RPh, M.S., E.M. Kolassa, MBA, Ph.D., Brian Reisetter, RPh, MBA,; Ph.D., Kevin Patterson, M.S., CPA, and Douglas Paul, PharmD
Chapter 31: Economics of Scheduling, De-bottlenecking, and; Cycle Time in Biopharmaceutical Manufacturing; D. Petrides, Ph.D., and C. A. Siletti, Ph.D.
Chapter 32: Intellectual Property Considerations in Scale-Up; of Biomanufacturing Processes; Janal Kalis
Chapter 33: A Method for Forecasting Industrywide; Biopharmaceutical Manufacturing Capacity; Requirements; Thomas C. Ransohoff, M.S., and Howard L. Levine, Ph.D.
Chapter 34: Worldwide Therapeutic Protein Production Capacity; Andrew Sinclair, MSc, and Claire Hill, MSc, MBA

Advances in Large Scale BioManufacturing and Scale-Up Production, 2nd ED

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