Whitepapers - BioPharm International

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Whitepapers

Achieving 21 CFR Part 11 Compliance with the iCE3

March 25, 2014

Rapid analysis, platform methods, and easy method development make the iCE3 ideal for analyzing biologics. In fact, these benefits have made iCE? cIEF assays one of the key assays for biologics characterization and quality control. In this application note we review the iCE3 features that simplify system start up, operation, and compliance with 21 CFR Part 11.

Industry Report on Viral Destruction: Smooth thermal processes consistently and effectively destroy these germs

March 25, 2014

This Q&A report includes information on viral inactivation and sterilization, integration, scale up, and advantages of high temperature short-time (HTST) and ultra-high temperature (UHT) processes.

Robustness of ionKey/MS System in the Analysis of Pharmaceutical Compounds in Biological Fluids

March 25, 2014

The robustness and reliability of pharmacokinetic (PK) data is an essential part of bioanalysis. LC-MS is the technique of choice in quantitative bioanalysis due to the high selectivity and sensitivity the technique offers.

Agilent Bio-Monolith Protein A Monitors Monoclonal Antibody Titer from Cell Cultures

March 25, 2014

To monitor monoclonal antibody titer and yield from cell-culture supernatants before expensive prep and large amounts of Protein A are employed, an analytical scale procedure helps determine the titer of monoclonal antibody for the optimal time for harvest of the mAb product. Here, pre-packed Agilent Bio-Monolith Protein A columns quickly capture mAb titer from cell supernatant.

Peptide Mapping of Glycoprotein Erythropoietin by HILIC LC/MS and RP-LC/MS

March 25, 2014

In this application note an Agilent ZORBAX Rapid Resolution High Definition (RRHD) 300-HILIC 1.8 ?m column and an Agilent AdvanceBio Peptide Mapping column are used in combination with time of flight (TOF) mass-spectrometry (MS) for mapping EPO protein. The work demonstrates the utility of HILIC as an orthogonal and complementary approach to reversed-phase LC/MS for peptide analysis.

TOYOPEARL AF-rProtein A HC-650F Host Cell Protein Removal

March 25, 2014

The following paper compares the host cell protein (HCP) removal capabilities of TOYOPEARL AF-rProtein A HC-650F, TOYOPEARL AF-rProtein A-650F, and another commercially available high-capacity protein A resin.

eBook: Troubleshooting Tips & Best Practices for Validation/Mapping

March 25, 2014

• Sensor placement: where, how many, and for how long? • Validation Master Plan checklist • Links to 1-hour webinars: Protocols, GAMP Guidance, and Regulations on Validation

Fast and Efficient Peptide Mapping of a Monoclonal Antibody (mAb): UHPLC Performance Using Superficially Porous Particles

March 25, 2014

In this work, an AdvanceBio Peptide Mapping column is used to generate a rapid and highly efficient peptide map at a traditional LC system pressure. The column achieves substantial improvements in peptide mapping during very fast run times and low system pressures, while still maintaining high peak-performance efficiency.

Are “Canned” Performance Qualification Protocols Ok?

February 25, 2014

What’s the quickest solution to a robust PQ of your environmental monitoring system: DIY or vendor supplied? This article discusses the keys to evaluating “canned” PQ documents from suppliers and options for creating your own protocols. Also, is skipping the PQ process an option? Learn more…

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