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Optimizing Downstream Purification Processes:
New approaches and benefits to bioprocess chromatography
Increased cell culture titers and product demand is driving higher protein mass loads into downstream processing. These higher titers have created a downstream bottleneck placing an increased emphasis on the purification of biomolecules and the need for new solutions. There is a greater need for process flexibility to maintain column and tank sizes due to facility fit and an escalated challenge for impurity removal with the higher loads. In this webcast, Shelly Cote Parra, Sr. Applications Scientist at Life Technologies, discusses new approaches to improve performance of cation exchange and anion exchange chromatography. Click here to learn more. |
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Reducing the Host Cell DNA Quantitation Bottleneck:
Approaches for Improved Sample Preparation and Throughput
The removal of impurities arising from host cells used for the production of biopharmaceutical products is a crucial step in the purification process. Regulatory guidance for products produced in cell culture specifies that residual host cell DNA content in the final product should be as low as possible. Because of the low sample throughput typical of most quantitative DNA assays, host-cell DNA quantitation can become an analytical bottleneck during process characterization. In this webcast, speakers will discuss a qPCR-based system for highly sensitive, accurate quantitation of residual host-cell DNA from a variety of cellular production systems. Click here to learn more.
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Streamlining Downstream Process Development
Normal-flow filtration is used throughout downstream processes for biologics including depth, sterile, and viral filtration applications. Because of its ubiquity in large-scale biomanufacturing, using the most efficient normal-flow filter media area and type can lead to significant cost savings. But determining the most effective media type and area can be time consuming, labor intensive, and complicated because of a lack of specialized laboratory-scale equipment. This white paper describes how Genentech Inc. and PendoTECH collaborated on developing an integrated filter-sizing system that addresses several disadvantages of the equipment commonly used. Click here to learn more.
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Mycoplasma In-Process and Lot Release Testing: To PCR or Not to PCR
Mycoplasma are the simplest self-replicating prokaryotes, and they are frequent contaminants of cell cultures. Detection of mycoplasma is extremely important; but because of their small size, limited turbidity produced in culture, the wide diversity of mycoplasma species, and other factors, detection of mycoplasma can be challenging. Some common culture methods of mycoplasma detection for cell bank and raw material release, in-process, and lot release testing have a long turnaround time (minimum 28 days). This white paper examines alternate methods of mycoplasma detection with shorter turnaround times, such as polymerase-chain-reaction (PCR)—based assays. Click here to learn more.
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A Brief History of Perfusion Biomanufacturing
BioProcess International, October 2011
Read more.
Microanalytical Techniques for Identifying Nonprotein Contaminants in Biologics
BioProcess International, February 2010
Read more.
Performance Characteristics of Host-pCell DNA Quantification Methods
BioProcess International, October 2007
Read more.
How to Choose an Industrial Cation Exchanger for IgG Purification
BioProcess International, October 2010
Read more.
Scale-Up of a Plasmid DNA Purification Process
BioProcess International, December 2010
Read more.
Biopharmaceutical Quality Assurance
BioProcess International, November 2008
Read more.
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