|
Published by: BioPlan Associates, Inc.
Published: Nov. 1, 2007 - 1220 Pages
Table of Contents
- 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
AbstractA 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.
Get Full Details About This Report >>
|
|
US: 800.298.5699
Int'l: +1.240.747.3093
|
|
|
