October 30, 2009
By:Nathan T. Whitford
The USP General Chapter <467> on Residual Solvents became effective on July 1, 2008. Alternate methods may need to be developed and validated for compounds and any other unlisted solvents used in manufacturing that cannot be tested by the General Chapter's GC method. Lancaster Laboratories' analysts have been utilizing a technique referred to as a self-validating method. The benefit to this self-validating method approach includes a faster timeline and is more cost effective than the traditional approach for clients having a short term or infrequent need for testing.
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October 21, 2009
Lancaster Laboratories' Professional Scientific StaffingSM service has been specifically designed to give you the "non-permanent" workforce you need for anywhere from one year to 10 years or more with no worries about co-employment and at lower costs than fixed headcounts.
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October 13, 2009
By:Jon S. Kauffman
Profiling of impurities in biopharmaceuticals and their associated intermediates and excipients is a regulatory expectation. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays can be quite challenging. Due to the range of potential impurities, many different analytical strategies are needed.
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October 5, 2009
By:Travis Emig
With the global economy in a recession, a vast majority of companies are being forced to cut costs and control spending. Full Time Equivalent Staffing Programs are value-added programs that will allow companies to project all of their outsourcing costs for an entire year in order to lock in on set annual costs.
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July 8, 2009
By:Bio-Rad
Ceramic Hydroxyapatite media requires specific considerations during process-scale chromatography packing. This article describes straightforward best practices for successful and reproducible CHT media column packing at process scale.
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July 8, 2009
By:Bio-Rad
Antibody-based drugs represent a growing segment of the pharmaceutical industry and one of the most promising classes of therapeutic drugs. However, production of monoclonal antibody (MAb)?based drugs remains very costly, and solutions to lower production costs are needed. The use of ion exchange chromatography to directly capture MAbs from cell culture streams or as a polishing step after an affinity separation may be a way to reduce costs.
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July 8, 2009
By:Xuemei He, Cheryl Aberin, Mark Snyder
The first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies is their capture from plasma or tissue culture supernatants. Protein A-based media are by far the most common class of affinity products used for this purpose. In combination with ion exchange and ceramic hydroxyapatite chromatography, protein A-based media have been successfully used in the large-scale purification of numerous licensed mAb drugs.
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July 8, 2009
By:Cheryl Aberin, Randy Jacinto, Mark Snyder
Apatite-based media have been shown to be effective chromatographic supports for monoclonal antibody (mAb) purification. A two-step purification platform consisting of affinity medium capture followed by a CHT ceramic hydroxyapatite or CFT ceramic fluoroapatite media polishing step results in highly purified chimeric IgG by removing leached protein A, HCP, DNA and MAb aggregates
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July 8, 2009
By:Kim Brisack, Christopher Foster, Larry Cummings, Mark Snyder
Bio-Rad InPlace columns offer a unique solution for packing media because they are designed with low-shear slurry valves, which minimize damage to media such as ceramic hydroxyapatite. The InPlace column slurry valves are used for transferring media into and out of the column without removing the top flow adaptor. The valves are on the side of the column wall and do not interfere with flow dynamics.
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