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 should be undertaken only with the greatest seriousness. Indeed, the opening lines of the ancient Chinese volume stress the critical importance of warfare: The art of war is of vital importance to the State. It is a matter of life and death, a road either to safety or to ruin. Hence it is a subject of inquiry that can on no account be neglected. ( 1 ) The essence of conflict is timeless, but the means and methods used continuously evolve. Modern ideas for supply chain surety were codified in 300 BC. The strategic framework expounde...
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 shown that traditional stainless steel systems incur higher costs for their cleaning and rinsing operations, which include disposal of liquid waste ( 3 ). Perhaps a broader concern today for disposal of single-use processes is their potential environmental impact. Some studies have compared this for disposables with the energy consumption demands of stainless steel systems for sterilization, cleaning, and raw mater...
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 are no longer necessary for a particular stage of the life cycle are down regulated and those required for colonization or infection are expressed ( 2 ). PRODUCT FOCUS: VACCINES AND LYME DISEASE TREATMENTS PROCESS FOCUS: PRODUCTION WHO SHOULD READ: QA/QC, PRODUCT DEVELOPMENT, PROCESS DEVELOPMENT, AND MANUFACTURING KEYWORDS: MICROBIOLOGY, BACTERIAL CULTURE, MEDIA OPTIMIZATION, VALIDATION, BOVINE SERUM ALBUMIN LEVEL: INTERMEDIATE The best-characterized example of that coordinated response is in production...
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 is the overall number of criteria growing, but in fact there are users who must consider many different features in specifying their production media. Here we outline and categorize many functions now desired from production media, emphasizing serum-free media (SFM) and feed supplements. Although some culturists continue to operate using animal sera, for most cell culture formats (e.g., Chinese hamster ovary or CHO cells) and production modes (e.g., fed batch) SFM has become standard ( 1 , 2 ). PRODUCT FOCUS: ALL BIOLOG...
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 tell which is right for your application? Here we describe six commonly used fermentor and bioreactor impellers, explain how they work, and identify which may perform best for culturing certain animal, insect, plant, yeast, and bacterial cell lines. How Blade Orientation Affects Mixing: All impellers are designed to homogenously mix cells, gases, and nutrients throughout the culture vessel. The mixing action evenly distributes oxygen and nutrients to cells for healthy growth, keeps them from settling to the bottom of the vessel, and helps to maintain a u...
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 of robust processes. This event is regarded by the industry as the most comprehensive event that brings you best practices across the spectrum, including the most critical stages of upstream and downstream processing. Keynote Presentations: “How Do We Get to 30 g/L Using Fed-Batch Technology? What Are the Limitations?” by Thomas Ryll (director of cell culture development at Biogen Idec), “Thoughts from the New Kids on the ...
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 Applications: Inoculum transfer, sampling, sterile connections, and bulk material handling Features: These disposable connectors allow for the dry connection of two separate sterile fluid pathways while maintaining the sterile integrity of both. Connections can be made in seconds, anywhere, even outside a controlled air environment. The connect...
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 sectors to raise the profile of S&T policy in the United States. C-Pet was lead sponsor (with The Center for Policy on Emerging Technologies, the University of Maryland Biotechnology Institute, and the Society for Industrial Microbiology) of a meeting on 26 September 2008 to discuss science, technology, and the presidential election. Some highlights of that meeting are presented here. The Keynote: Barack Obama’s lead technology surrogate, Michael Nelson (visiting professor at Georgeto...