In my opening editorial, I referred to an industry in transition. This is being driven by challenges that are by no means unique to biotech: all other industry sectors are experiencing similar pressures. We are seeing the impact in terms of factory design, manufacturing technologies, validation and business processes; these are all themes that have been addressed in this supplement. The big innovation in terms of manufacturing systems has been the wholesale acceptance of disposable manufacturing technologies during…
2009
Defending the Supply Chain
Competition, whether commercial or military, focuses on two common objectives: making choices and converting those choices into direct action. Like commercial competition, most wars are won or lost through effective or faulty logistics. The Art of War by Sun Tzu is not merely a book about war. Captains do not carry it into battle with them. It is a book about strategy that generals and statesmen study. Mobilizing for war, committing an army to battle, and risking a power base…
Managing Solid Waste from Single-Use Systems in Biopharmaceutical Manufacturing
The increasing implementation of single-use systems (SUS) in biopharmaceutical manufacturing has been driven by multiple factors including cost reduction, increased flexibility, improved process development time, and reduced capital investment. But questions are being raised over the disposal of solid waste materials from this alternative technology. Disposal concerns may not be justified on financial considerations because solid-waste disposal costs represent only a small proportion of the total manufacturing costs when using disposable systems (1, 2). Furthermore, comparative studies have…
A Readily Available Source of BSA Consistently Supports Cultivation and Differential Gene Expression
Lyme disease caused by the spirochete Borrelia burgdorferi is the leading vector-borne illness in the United States (1). The natural infectious lifecycle of B. burgdorferi is complex in that it is necessary for the bacteria to colonize both an arthropod vector (the Ixodes scapularis tick, pictured right) and a mammalian host (2). As the bacteria transitions between those two diverse niches, it alters the expression of its major outer surface proteins (Osps) such that expression of those that…
Many Considerations in Selecting Bioproduction Culture Media
Not long ago, the ability to support efficient large-scale culture of cells was the main factor in choice and development of production media. However, a number of new performance demands have been imposed on production media (as listed in the “Key Factors†box). These new criteria arise from such sources as the demand for increased efficiency in a number of production operations, goals invoked by new quality initiatives, and a more science-based approach to process development. Not only…
Which Impeller Is Right for Your Cell Line?
When growing microbes or animal cells in a stirred-tank reactor, it is critical to choose the impeller type that is best suited to your process. Select the wrong impeller, and you could make chop suey of your filamentous fungi. Pick the right impeller, and you could greatly increase yields of your fussy mammalian cultures such as Chinese hamster ovary (CHO) and Vero kidney epithelial cells. With a wide range of impeller designs to choose from, how do you…
Biopharmaceutical Development and Production Week
IBC Life Sciences’ Biopharmaceutical Development and Production Week will help you move forward in the pharmaceutical marketplace and will address how to benchmark efforts against industry leaders and the latest strategies to overcome regulatory hurdles with in-depth, real-world case studies of the most recent advances driving the biopharm industry today. 22nd International Antibody Development and Production On 4–6 March, IBC’s Antibody Development and Production conference will help you evaluate the latest scientific and technical approaches to successfully accelerate the development…
Global Marketplace
Sample Preparation Product: FlowCytoPrep5000 system Applications: Cell analysis Features: The FlowCytoPrep5000 is a biological sample preparation system designed to allow combined automated sampling, sample preparation, and realtime flow cytometric analysis. The system is appropriate for advanced cell culture monitoring and control, high-throughput screening, and handling multiple samples without manual preparation. When interfaced with a flow cytometer, the system enables fully automated operation including sampling, washing, fixing, staining, diluting, and injecting. Contact MSP Corp. www.mspcorp.com Sterile Connectors Product: Kleenpak sterile connectors…
The Future of US Science and Technology Policy
The United States’ global leadership in science and technology (S&T) is accompanied by a disturbing anomaly: a lack of interest in S&T issues in the country’s policy community. Although controversy has focused on specific issues (notably, embryonic stem cell research and climate change), its context has been less S&T and more about wider policy issues. The Center for Policy on Emerging Technologies (C-PET) is a nonpartisan think tank established with bipartisan support and participation from the corporate, policy, and civil…