spacer
home > ebr > spring 2009 > expanding expression
PUBLICATIONS
European Biopharmaceutical Review

Expanding Expression

 

Nearly 55 per cent of biomanufacturing facilities today are actively considering alternative expression systems for products in R&D (1). By the time these products leave the development pipeline, there may well be far greater numbers of biopharmaceutical expression systems in commercial manufacturing than we have seen over the past 30 years. While there have been substantial improvements in the classic three expression systems (E coli, CHO and yeast) over the years, until recently, there was a general lack of interest in the adoption of newer platform technologies. The result is that nearly all biotherapeutic products manufactured today use the same familiar technologies.

The underlying reason for this stagnation has been the industry’s inherent caution. “It is a conservative industry – nobody ever got fired for using E coli, yeast or CHO,” says Dr Tillman Gerngross, currently Professor of Engineering at Dartmouth College. One reason for the slow adoption of expression system technologies in biomanufacturing is the regulated nature of the industry. Dr Gerngross has found that “making things cheaper while increasing regulatory risk has not been a winning formula in this industry: consider transgenic animals and plants”.

Cost saving is a relatively small part of the equation. Gerngross believes that new expression system technologies must improve product quality and have a direct therapeutic impact. Simply reducing costs is not enough: “Production costs are a small fraction of the final cost of goods – it roughly breaks down into one third production, one third purification and one third formulation and QC”. Therefore, a protein cost-of-goods might be as low as four per cent, which means reducing production costs will not affect the overall cost structure.

THE NEED FOR NEW EXPRESSION SYSTEMS

Now, however, the need for innovation in the biopharmaceutical sector has taken on a greater urgency. In his recent book on expression systems, Ronald Rader notes that “High-tech industries adopt new technologies so they can produce better, cheaper and faster. Sticking with what you know may seem safe, but in biomanufacturing, this may have more to do with the lack of knowledge about emerging alternatives” (2). A range of promising technologies have been available for some years, but many companies continue to rely on outdated expression systems, which may compound the risks inherent to new drug development. This lack of forward-thinking is having a stifling effect on biopharmaceutical manufacturing. In this increasingly competitive environment, companies are recognising that they may not be able to afford to continue along this path.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Eric S Langer is President at BioPlan Associates, Inc, a biotechnology and life sciences marketing research and publishing company in Rockville, Maryland. He has over 20 years’ experience in biotechnology and life sciences management and market assessment. He is an experienced medical and biotechnology market publisher, practitioner strategist, researcher and science writer. He has held senior management and marketing positions at biopharmaceutical supply companies, and teaches biotechnology marketing, marketing management, services marketing and bioscience communication at Johns Hopkins University and American University, among others. He is co-founder and Managing Partner at BioPlan Associates, Inc and has a degree in Chemistry from the University of Maryland and a Masters in International Business from American University.

spacer
Eric Langer
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Protagen Protein Services (PPS) expands capabilities for aggregate analytics to include dynamic light scattering (DLS)

Protein aggregation is a common challenge in the manufacturing of biological products. As one of the most sensitive techniques for the detection of aggregates, dynamic light scattering (DLS) provides a simple, fast and non-destructive testing method. An innovative technique based on a unique cuvette layout allows for accurate measurements with as little as a single µL of solution.
More info >>

White Papers

Systems Engineering for Complex Portable Medical Device Development

Phillips-Medisize

As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount. Taking a systems-engineering (SE) approach to development provides a holistic, organized, and deliberate method for identifying as well as reducing both patient and business risks early in the process. Furthermore, it facilitates efficient progression throughout the entire product development life cycle.
More info >>

 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement