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Biopharmaceutical Processing Book from C.H.I.P.S.

Advanced Technologies in Biopharmaceutical Processing
edited by Roshni L. Dutton

An increasing number of pharmaceuticals in human and veterinary medicine are being developed using advanced genetic and other methods that focus on modification of somatic and embryonic cells. These methods, in the setting of drug manufacture, call for new processes that go beyond the traditional unit processes of chemical and biological production, e.g., fermentation.

Advanced Technologies in Biopharmaceutical Processing is the first to describe in detail these advanced biological processes and show how they are applied to the production of biopharmaceuticals, from product generation and purification to finish-fill operations.

The work explains how technologies developed in the last decade function similarly to unit processes for producing advanced biopharmaceuticals, such as hormones, cytokines, therapeutic enzymes, modified proteins, and transgenic cells--to name a few.

From large-scale animal cell bioreactors to patient-customized products, Advanced Technologies in Biopharmaceutical Processing describes the effects of new technologies on biopharmaceutical processes and guides users on how to apply new technologies in process development.

Contents

1. Overview of the Biopharmaceutical Industry

  • The expanding biopharmaceutical market
  • A brief history of biopharmaceuticals
  • The biopharmaceutical process
  • Biological products

2. Regulatory Requirements for Processing Biopharmaceuticals

  • Risk-based approaches and smart regulations
  • New and emerging biothreats
  • Transmissible spongiform encephalitis
  • Prion and viral clearance
  • Product contact materials, leachables, and extractables
  • Additives
  • Trends in validation
  • Disposables
  • Process analytical technology
  • New production technologies and new issues

3. Genomics, Proteomics, and Metabolomics Impact on Biopharmaceutical Processing

  • Genomics
  • Proteomics
  • Metabolomics
  • Glycomics
  • Metabolic engineering
  • Emerging microbial expression systems
  • Systems biology
  • The future of biomanufacturing

4. New Technologies in Biopharmaceutical Upstream Processing

  • Facilities
  • Media
  • Cell banking and inoculum train
  • Production
  • Scale-up
  • Scale-down
  • Harvesting anc concentrating
  • Integration with downstream purification

5. New Technologies in Biopharmaceutical Downstream Processing

  • Process chromatography
  • Membrane chromatography
  • Protein crystallization
  • Impact of disposables on downstream processes
  • Process integration

6. Biopharmaceutical Product Formulation, Preservation, and Presentation

  • Pre-formulation and formulation development
  • formulation additives
  • Preservation
  • Presentation

7. Biopharmaceutical Product and Process Monitoring, Analysis and Control

  • Instrumentation and control foundation
  • Process optimization
  • Linking to the enterrise
  • Process analytical technology

8. Discrete Automation in BioProcessing Unit Operations

  • Trends in automated discovery and process development
  • Trends in production and scale-up
  • Trends in fill-finish operations
  • Automation and isolation
  • The need for automation integration
  • Discrete automation, process analytical technologies, and the move to continuous processing
  • Automation simulation and economic modeling

9. Emerging Biopharmaceutical Platforms

  • Transgenic protein production systems
  • Gene and cellular therapies

Index

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Advanced Technologies in
Biopharmaceutical Processing

edited by Roshni L. Dutton
2007 284 pages $210.95 + shipping
Texas residents please add 6.75 % sales tax

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