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Transcriptomics and the Production of Recombinant TherapeuticsTranscriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.
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Spectrum Pharmaceuticals to Develop Biosimilar RituximabCalifornia-based biopharmceutical company Spectrum Pharmaceuticals will develop a biosimilar version of Swiss pharmaceutical giant Roche Holding AG's monoclonal antibody drug rituximab. Spectrum aims to achieve this through a partnership with Viropro Inc (Irvine, CA).
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Employing Murine MAbs as Ancillary Products in Cell Therapy Manufacturing, Part 2, A Case Studyby Steven Ford and William E. Tente Chimeric Therapies, Inc. Experience shows that murine MAbs used in cell therapy manufacturing can be produced with safety concerns in mind. In such cases, adequate characterization ensures that they retain functional integrity.
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Demonstrating the Consistency of Small Data Sets: Application of the Weisberg t-test for Outliersby Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
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Managing Your Career: Recruiter-Proof Your Organizationby David G. Jensen Your best people will be targeted.
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Employing Murine MAbs as Ancillary Products in Cell Therapy Manufacturing, Part 2, A Case Studyby Steven Ford and William E. Tente Chimeric Therapies, Inc. Experience shows that murine MAbs used in cell therapy manufacturing can be produced with safety concerns in mind. In such cases, adequate characterization ensures that they retain functional integrity.
Latest:
Demonstrating the Consistency of Small Data Sets: Application of the Weisberg t-test for Outliersby Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
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Qualification of Network Components and Validation of Networked Systemsby Ludwig Huber at Agilent Technologies GmbH and Rory Budihandojo To comply with 21 CFR Part 11, your networked systems require the same validation and qualification steps as those for a single computer. Shared servers and multiple access also add requirements that are unique to networks. Italicized words in this article are defined in the "The Glossaryy" on the last page of the online version.
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Using Macros and Spreadsheets in a Regulated EnvironmentSpreadsheet calculations are popular in all kinds of businesses. A macro is a set of commands that can be embedded in a document to add functionality to standard programs and to automated processes.
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After the Consent Decree — An Uphill Battle for Affected CompaniesQuality should be built into manufacturing systems instead of being imposed as a corrective action.
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Systematic Troubleshooting for LC/MS/MS: Part 2, Large-Scale LC/MS/MS and Automationby Naidong Weng and Timothy D.J. Halls, Covance Laboratories, Inc. Meeting the challenges of large-scale LC/MS/MS can improve the analytical processes that support biopharmaceutical drug development. The conclusion of this article presents troubleshooting techniques for LC/MS/MS and illustrates an automation strategy.
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Designs for Bioassays with Plate Location Effectsby Brian Schlain, Hitendra S. Jethwa, Meena Subramanyam, Kevin Moulder, Bhavna Bhatt, and Michael Molloy Standard 96-well microplate assays are prone to edge and bowl effects. Such plate location effects can badly bias potency estimates. Easy-to-use plate layouts enable scientists to adjust estimates for such effects when analyzing new production drug batches. This article is indebted to the work reported by Russell Reeve (BioPharm, July 2000) and the subsequent letters from David Lansky and Reeve (BioPharm, September 2000).
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Designs for Bioassays with Plate Location Effectsby Brian Schlain, Hitendra S. Jethwa, Meena Subramanyam, Kevin Moulder, Bhavna Bhatt, and Michael Molloy Standard 96-well microplate assays are prone to edge and bowl effects. Such plate location effects can badly bias potency estimates. Easy-to-use plate layouts enable scientists to adjust estimates for such effects when analyzing new production drug batches. This article is indebted to the work reported by Russell Reeve (BioPharm, July 2000) and the subsequent letters from David Lansky and Reeve (BioPharm, September 2000).
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Liposomes (a Review): Part Two, Drug Delivery Systemsby Suggy S. Chrai, R. Murari, and Imran Ahmad Good manufacturing processes require that lipid vesicles be reproducibly uniform in size, carry the drug in sufficient concentration, and remain stable for an acceptable shelf-life under varying temperatures. Following these guidelines improves the analytical processes that support biopharmaceutical drug development.
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Liposomes (a Review): Part Two, Drug Delivery Systemsby Suggy S. Chrai, R. Murari, and Imran Ahmad Good manufacturing processes require that lipid vesicles be reproducibly uniform in size, carry the drug in sufficient concentration, and remain stable for an acceptable shelf-life under varying temperatures. Following these guidelines improves the analytical processes that support biopharmaceutical drug development.
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Designs for Bioassays with Plate Location Effectsby Brian Schlain, Hitendra S. Jethwa, Meena Subramanyam, Kevin Moulder, Bhavna Bhatt, and Michael Molloy Standard 96-well microplate assays are prone to edge and bowl effects. Such plate location effects can badly bias potency estimates. Easy-to-use plate layouts enable scientists to adjust estimates for such effects when analyzing new production drug batches. This article is indebted to the work reported by Russell Reeve (BioPharm, July 2000) and the subsequent letters from David Lansky and Reeve (BioPharm, September 2000).
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Designs for Bioassays with Plate Location Effectsby Brian Schlain, Hitendra S. Jethwa, Meena Subramanyam, Kevin Moulder, Bhavna Bhatt, and Michael Molloy Standard 96-well microplate assays are prone to edge and bowl effects. Such plate location effects can badly bias potency estimates. Easy-to-use plate layouts enable scientists to adjust estimates for such effects when analyzing new production drug batches. This article is indebted to the work reported by Russell Reeve (BioPharm, July 2000) and the subsequent letters from David Lansky and Reeve (BioPharm, September 2000).
Latest:
Systematic Troubleshooting for LC/MS/MS: Part 2, Large-Scale LC/MS/MS and Automationby Naidong Weng and Timothy D.J. Halls, Covance Laboratories, Inc. Meeting the challenges of large-scale LC/MS/MS can improve the analytical processes that support biopharmaceutical drug development. The conclusion of this article presents troubleshooting techniques for LC/MS/MS and illustrates an automation strategy.
Latest:
Designs for Bioassays with Plate Location Effectsby Brian Schlain, Hitendra S. Jethwa, Meena Subramanyam, Kevin Moulder, Bhavna Bhatt, and Michael Molloy Standard 96-well microplate assays are prone to edge and bowl effects. Such plate location effects can badly bias potency estimates. Easy-to-use plate layouts enable scientists to adjust estimates for such effects when analyzing new production drug batches. This article is indebted to the work reported by Russell Reeve (BioPharm, July 2000) and the subsequent letters from David Lansky and Reeve (BioPharm, September 2000).
Latest:
Designs for Bioassays with Plate Location Effectsby Brian Schlain, Hitendra S. Jethwa, Meena Subramanyam, Kevin Moulder, Bhavna Bhatt, and Michael Molloy Standard 96-well microplate assays are prone to edge and bowl effects. Such plate location effects can badly bias potency estimates. Easy-to-use plate layouts enable scientists to adjust estimates for such effects when analyzing new production drug batches. This article is indebted to the work reported by Russell Reeve (BioPharm, July 2000) and the subsequent letters from David Lansky and Reeve (BioPharm, September 2000).
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Outsourcing Outlook: Truth in Outsourcingby William Bierce and Jim Miller Is that great deal too good to be true?
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Simplifying Pharmacologic Analysis with Programmable Scientific Softwareby Joseph M. Przechocki OriginLab Corporation The mathematics behind quantifying the response of different chemical compounds competing with an agonist for the same biological binding site are well understood, but the process can be repetitive and tedious. Learning full use of new scientific software will give you the time to put your talents to more creative use.
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Considerations During Development of a Protein A-Based Antibody Purification Processby Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.
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Considerations During Development of a Protein A-Based Antibody Purification Processby Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.
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Considerations During Development of a Protein A-Based Antibody Purification Processby Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.
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Considerations During Development of a Protein A-Based Antibody Purification Processby Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.
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Considerations During Development of a Protein A-Based Antibody Purification Processby Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.
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Considerations During Development of a Protein A-Based Antibody Purification Processby Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.
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Considerations During Development of a Protein A-Based Antibody Purification Processby Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.
