Upstream Processing

Moving to the Next Level of Technology

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The protein manufacturing industry faces many challenges today – large stainless steel bioreactors cause downstream processing bottlenecks and come with a large footprint and high CAPEX. To address these challenges, DSM Biologics has developed the XD® Process Technology. This proprietary technology uses disposable systems to simplify the downstream process and lower CAPEX. In this on-demand webcast, Rolf Douwenga, Vice President of Global Research and Development for DSM Biologics, discusses:

• Issues Facing Protein Manufacturing Industry
• How DSM Addresses These Issues
• In-depth Explanation of XD Process Technology

Join Douwenga as he details several case studies using XD Process Technology to enable a more flexible and simplified downstream process.

November 1, 2009

Advancing Cell Culture-Based Biopharmaceutical Programs using Metabolomics

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Metabolomics is an approach for obtaining insight into the metabolism of a population of cells in a culture environment. As such, it has had particular utility in the area of upstream bioprocess optimization of biopharmaceuticals. In this on-demand educational webcast, Kirk Beebe of Metabolon illustrates the many uses of metabolomics for various bioprocessing activities, including:

• Cell Line Development/Clone Selection
• Targets for Pathway Engineering
• Media Development
• Process Optimization & Scale-up
• And more.

Join Beebe as he provides a deeper understanding of metabolomics technology and how it is helping to advance cell culture-based biopharmaceutical programs.

November 1, 2009

Using Innovation to Drive Competitive Advantage

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    Figure 1: () STOCKXPERT (WWW.STOCKXPERT.COM) After spending decades as the “sleepy†segment of the biopharmaceutical industry, vaccines are now seen as one of its highest growth segments. Major pharmaceutical companies — Novartis AG (www.novartis.com) and Pfizer, Inc. (www.pfizer.com), for example — are aggressively entering this area. Those already in it are expanding capacity and increasing business development activity. Indeed, access to the vaccines business was a major driver of Pfizer’s acquisition of Wyeth Pharmaceuticals (www.wyeth.com) (1). Several factors…

September 1, 2009

Maintaining Product Titer While Replacing Undefined Components in a CHO Culture System

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    Proteins, hydrolysates, and lysates of plant or yeast origin are commonly used in cell culture media for large-scale manufacturing processes for human biotherapeutics. Lot-to-lot variability in the composition of such constituents is well established and can affect multiple biological performance indicators. Our goal was to replace an undefined, protein-containing medium with a chemically defined medium (meaning the chemical structure and concentration for each component in a formulation is known). Such a formulation should be free of protein and…

September 1, 2009

Rethinking Media Performance

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    Fetal bovine serum (FBS) was — and in many cases still is — the supplement of choice to maintain the viability of mammalian cells in culture. However, there are considerable limitations to its use. In the early days of cell culture, the issues surrounding serum were mainly its variable performance and the potential to contaminate cultures with fungi, viruses, and bacteria. Early attempts to produce a serum-free medium (SFM) were academic exercises that usually relied on the use…

September 1, 2009

Single-Use Strategies in Bioprocessing

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BioProcess International has followed, from the beginning, the ways in which single-use technologies have transformed the landscape of industrial bioprocessing. On 18 March 2009, we organized a panel session at the annual Interphex conference (Jacob Javitz Center, NYC) to drive discussion toward longer-term implications of single-use components and technologies on the future of bioprocessing. Is their use a cost-saving strategy overall? What economic factors are driving their adoption? The panelists were prepared to address such topics as economic considerations in…

June 1, 2009

Development and Qualification of a Generic IgG Quantification Assay Using Surface Plasmon Resonance

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Fast, precise, and accurate quantification technologies are indispensable for efficient process development in applications such as IgG production in a GXP environment. Based on surface plasmon resonance (SPR) technology, the Biacore C system from GE Healthcare (www.biacore.com) is an alternative technology for IgG quantification that has benefits over traditional methods. Assay development is simplified and accelerated due to real-time detection. Assay hands-on time is reduced, and sample throughput can be increased using automation and efficient data evaluation with regulatory-compliant software.…

June 1, 2009

Development of a Turn-Key Harvest Solution for Small-Volume Bioreactors

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Over the past 10 years, disposable bioreactors have grown from a niche tool servicing small-scale projects to a common and essential component in the CGMP production of human therapeutics (1). Recent advances in filter integration, aseptic connectors, and disposable sensing allow entire cell culture processes to be performed using only single-use components. However, harvest and clarification operations remain largely dependent on centrifugation, cross-flow filtration, and depth filtration (2), which are all techniques that have not been widely adapted to single-use…

June 1, 2009

A Single-Use, Scalable Perfusion Bioreactor System

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We have previously described a patented nonsparging, nonbubbling oxygen transfer method (1). This method is based on interaction between the air-exposed smooth surface of a bioreactor vessel and culture medium repeatedly sweeping across it with a certain force, which seems to generate microscopic bubbles among the water molecules (2). We manufactured high–oxygen-transfer Current suspension bioreactors with working volumes of 5 L, 50 L, 150 L, and 300 L. Here we describe the use of these suspension bioreactors as “artificial lungs”…

June 1, 2009

Automated Liquid Handlers As Sources of Error

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Use of automated liquid handling equipment for rapid testing and reproducible screening of thousands of molecules, cells, and compounds has become an essential component of life-science laboratories across the globe. Along with an increase in such use, transferred volumes have shrunk, as demands increase on transfer accuracy and precision when aspirating, diluting, dispensing, mixing, and washing. Automated liquid handlers are generally used to increase the productivity and repeatability of volume transfer, but as discussed here, they are still prone to…

June 1, 2009