|
Article Excerpt
The number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time, in addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations, companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.
Creating processes that are not only optimal and robust, but also economical in a time and resource efficient manner is the Holy Grail for the biotech industry today. Regulatory initiatives such as Quality by Design and PAT require an improved process understanding earlier in the product life cycle. (1-4)
Recent advances in fermentation and cell culture processes have increased cell densities and protein titers in process fluids, requiring reliable upstream technologies to handle growing production demands. (5), (6) Moreover, within the bioprocessing industry there is a strong trend toward the application of single-use technologies, eliminating the expense of cleaning and cleaning validation, a major cost factor in operating reusable systems. One of the commonly used technologies for primary separation after fermentation is tangential flow filtration (TFF). (7) TFF processes have traditionally used cassettes or hollow fiber formats. Typically, TFF cassettes are installed in stainless steel housings that require post-use cleaning and validation of cleaning. The installation and preconditioning steps before process use are time consuming and require a reasonable level of skill to avoid potential malfunction. Hollow fiber filter systems provide an alternative primary separation technology. However, this open channel format tends to require relatively high pumping rates for optimal performance. Achieving these high rates with fully disposable equipment...
|
|
Looking for additional articles?
Search our database of over 3 million articles.
Looking for more in-depth information on this industry?
Search our complete database of Industry & Market reports by text, subject, publication
name or publication date.
About Goliath
Whether you're looking for sales prospects, competitive information, company
analysis or best practices in managing your organization,
Goliath can help you meet your business needs.
Our extensive business information databases empower business
professionals with both the breadth and depth of credible,
authoritative information they need to support their business
goals. Whether it be strategic planning, sales prospecting,
company research or defining management best practices -
Goliath is your leading source for accurate information.
|
|
