Date published July 2010

 

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Therapeutic Protein Production: A Changing Landscape Report - Overview

Report BrochureAuthor: K. John Morrow, Jr. Ph.D.

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

Figure 

Bioprocessing is the branch of biotechnology dealing with the production and purification of biological materials of commercial interest. This report focuses on the wide range of disciplines applied to the rapid and economical production of protein molecules. While most antibody biologics are anti-cancer agents, there are a number of other disease indications, including immune dysfunction, infectious disease and mental illness management, fueling the growth of this therapeutic area.

Trends in the upstream and downstream areas of monoclonal antibody production are encouraging and should help control the manufacturing costs of monoclonal antibodies. As indicated in this report, an increase in the use of disposables in upstream and downstream unit operations is underway. This shift away from fixed, reusable equipment is driving change in the industry, making available to cash-strapped small companies workable product quantities at affordable costs and allowing companies to enter clinical trials with promising but higher-risk, second-tier candidates. The availability of disposables has caused major biotech companies to question their strategy of large capital investments in reusable equipment.

This report identifies the continuing upstream versus downstream gap problem for the industry. Progress toward producing more protein per unit volume of culture medium has moved more rapidly and is placing pressure on the rates at which these proteins can be purified at the downstream end. This overall expansion has motivated regulatory agencies in Europe to redefine intellectual property guidelines and rules governing biosimilars. Legislation governing biosimilars has been passed in the US as part of the recent 2010 health care legislation.
This report also evaluates rising concern over the threat of Asian and European competition to the American biotech industry

About the author:
K. John Morrow, Jr., PhD, is a writer and consultant for the biotechnology industry. He obtained his PhD in genetics from the University of Washington in Seattle, and completed his training with post-doctoral studies in Italy at the Universitá di Pavia and Philadelphia at the Fox Chase Cancer Institute. He has held faculty positions at the University of Kansas and at Texas Tech University Health Sciences Center. His writings include over 200 peer-reviewed journal papers, non-peer–reviewed coverage of the biotechnology industry, books, and marketing reports. A number of companies, including Meridian Bioscience, Affitech, Henderson-Morley Biotechnology, Brandwidth Communications, and Emergent Technologies have taken advantage of his consultancy services, provided through Newport Biotechnology Consultants. He resides in Newport, KY.