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Therapeutic Protein Production: A Changing Landscape

CHI Insight Pharma Reports
July 1, 2010
SKU: CHI2765053

Abstract Table of Contents Search inside this report Related Reports

Therapeutic Protein Production: A Changing Landscape examines the implications of and advances in upstream and downstream operations used in the production of therapeutic proteins. Improvements in protein yields per unit volume, the significance of introducing disposables throughout the process and the shift to animal extracts-free culture media are three of the major themes covered by this report. The impact of global competition, lower barriers to entry and the shift in the production bottleneck from upstream to downstream unit operations are presented together with likely shifts impacting the production outlook over the next five years. More than a dozen tables and figures in this report summarize the report’s findings.

Some of the topics highlighted in the report:

Pros and cons of animal cell culture
Development of alternative production cell lines
Improving protein production per volume of culture media
Impact of disposables on cost and availability of proteins
Bottlenecks appear on the downstream side of production
Shift away from capital spending on fixed, reusable infrastructure
Tackling biosimilar regulatory questions
Dimensions of Asian and EU competition

Chapter 1: Introduction; 1.1. Bioprocessing in the 21st Century; A Changing Landscape; 1.2. Bioprocessing Advances Are Incremental in Scope; 1.3. Range of the Industry Challenge
Chapter 2: Upstream Processing; 2.1. M Mammalian Cell Culture Expression Systems; 2.2. M Mammalian Cell Culture Media; 2.3. P Post-Translational Modifications; 2.4. O Other Production Alternatives; 2.5. Bioreactors: Design and Function
Chapter 3: Downstream Processing; 3.1. D Disposables, Reusables; 3.2. P Purification Strategies; 3.3. M Monitoring Tools: HPLC-MS
Chapter 4: Optimizing Bioprocess Development; 4.1. T Time Is Money
Chapter 5: Current Regulatory Status of Biologics; 5.1. T The Biologics Problem
Chapter 6: Conclusions Drawn While on the Road Ahead; Thoughts on the; future of bioprocessing; 6.1. P Predicting the Future; 6.2. T The Rise of Foreign Competition; 6.3. M Marketing Issues; Costs; 6.4. O Options and Caveats
Appendix: Company Index with Web Addresses
TABLES: Table 1.1. A Wide Range of Species Under Study for Protein Production; Table 2.1. Selected List of Approved Recombinant Therapeutic Proteins Produced in Mammalian; Cell Lines (Messi 2009, See Appendix); Table 2.2. Mammalian Cell Culture Products and Media; Table 2.3. Recommendations by Regulatory Agencies and Physicians‘ Organizations for the Avoidance of Human or Animal Proteins in Drug Manufacturing; Table 2.4. Approved Therapeutic Protein-Based Products from E. coli; Table 2.5. Comparison of Plants Built to Accommodate Reusable Versus Disposable Upstream Bioprocessing Facilities; Table 3.1. Various Polishing Options; Table 3.2. Typical Platform for MAb Purification; Table 3.3. Companies Dealing with Liquid Chromatography Systems and Products; Table 4.1. FDA Biologics Approvals, 2009; Table 6.1. Comparative Salaries (in US $$) for High-Tech Occupations in Various Countries, 2008
FIGURES: Figure 2.1. Number (and Percentage Values Siding the Bars) of Recombinant Proteins Approved as Biopharmaceuticals in Different Production Systems*; Figure 2.2. General Scheme for Commercial Development and Production of a Plasma-Free; Recombinant Therapeutic Protein. In Every Step of the Manufacturing Process, Animal- or; Human-Derived Additives Are Replaced by Plant-Based or Synthetic Moleculesa); Figure 6.1. Cell-Free Synthesis Production Example

Therapeutic Protein Production: A Changing Landscape

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