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…
Author Archives: BPI Contributor
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…
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…
Many Considerations in Selecting Bioproduction Culture Media
Until recently, the ability to support efficient large-scale culture of cells was the main factor in choice and development of production media. But lately the industry has seen a number of new performance demands imposed on production media, such as:
• Support higher growth rates and culture densities
• Promote culture longevity and suppress apoptosis
• Support clone stability in continued passage
• Promote high product yield
• And many more.
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. Read this informative paper to learn more about the many functions now desired from production media.
Antibody Development and Production Conference
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…
Products, Services, and Literature
Disposable Bags Product: Bioprocessing bags Applications: Containment, mixing, and so on Features: Flexel 3D standard bags are designed for processing, storage, and transport of large-volume biopharmaceutical solutions. These disposable bags fit Sartorius Stedim Biotech’s Palletank containers or commonly available plastic drums. The bags provide a single-use alternative to traditional stainless-steel vessels in a range of applications. Standard Flexel 3D bags come as sterilized and ready-to-use stand-alone bags or filter-and-bag assemblies that incorporate a range of tubing, connections, filters, and bag…
Monitoring ATP Status in the Metabolism of Production Cell Lines
Because the development of industrial cell culture processes for production of recombinant proteins seeks high efficiency, reproducibility and predictability, it is important to have access accurate analytical tools. Although established analytical methods deliver useful data, they are incomplete because they only partially address the cellular metabolic state and also because no predictions can be made.
This paper discusses the process used to establish and evaluate an assay for rapid and reliable online measurement of intracellular ATP (adenoside-5′-triphosphate) to monitor the physiological state of cells in combination with other parameters (cell number, viability, and glucose consumption).
Considering Cell Culture Automation in Upstream Bioprocess Development
With the increasing importance of biologics in today’s pharmaceutical market, throughput and efficiency are crucial in developing a production cell line. Cell culture automation can be a good solution for high-throughput and labor-intensive areas of a development process. Because of the cost of the investment, there are many factors to be considered before committing to a purchase.
In this paper, Tim Gryseels, a senior scientist at Pfizer, discusses the important steps in identifying and purchasing cell culture automation, and how the automation process can reduce costs and increase throughput, efficiency and consistency.
Technologies and Training Move Sterility to New Levels
Take six people and sample the microbial ecosystem on their forearms, and you will find more than 240 distinct microbes (1, 2). So it becomes readily apparent why keeping a cleanroom “clean” is a difficult task. One problem is that we humans are limited in our visual capacities and can see objects down to only 50 µm (3). If we could see contaminating particles, we would likely be very quick to clean them away. In fact, cleaning and cleaning validation…