Whitepapers - BioPharm International



TOYOPEARL® AF-rProtein A HC-650F rProtein A Ligand Leakage

May 26, 2014

This application note compares the amount of leached Protein A ligand that is present in purified monoclonal antibody, post elution, when using TOYOPEARL AF-rProtein A HC-650F, TOYOPEARL AF-rProtein A-650F, and another commercially available high capacity Protein A resin. Protein A ELISA tests specific to each resin evaluated show that the TOYOPEARL AF-rProtein A HC-650F is very stable and exhibits a markedly lower level of ligand leakage compared to the other resins tested.

Handheld Raman- Rapid Counterfeit and Substandard Medicines Detection

May 19, 2014

A study of commonly counterfeited drugs concluded that 1064nm handheld Raman rapidly distinguishes substandard pharmaceuticals; thus providing the means for immediate removal from the supply chain.

Charge and Interaction Analysis for Predicting Antibody Formulation Stability

April 29, 2014

Combined measurements of net charge and kD were made in order to understand the difference between two formulations with different stability behavior. While they have approximately the same net charge, their stability is dominated by the secondary effects of asymmetric charge distributions and hydrophobic residues.

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.

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.

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

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.



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