Whitepapers - BioPharm International

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Whitepapers

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.

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

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.

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.

Confirming Accurate Particle Counting and Sizing on MFI Systems

February 25, 2014

Micro-Flow Imaging (MFI) provides accurate and sensitive detection of sub-visible particles and protein aggregates in biopharmaceuticals. Confirmation of instrument performance is demonstrated using NIST-traceable polystyrene beads. This application note provides a guide to best practices for handling standards and samples to ensure sensitive, accurate, and repeatable results.

Charge Variant Analysis using pH Gradients

January 28, 2014

This Application Note shows method development for charge variant profiling of monoclonal antibodies using pH gradient elution with Agilent Buffer Advisor Software and online pH and conductivity monitoring.

LC/MS Analysis of the Monoclonal Antibody Rituximab

January 28, 2014

In this Application Note, an Orbitrap-based mass spectrometer is used for high-confidence analysis of the intact and reduced forms of rituximab (monoclonal antibody), in biopharmaceutical product development and characterization.

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