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Whitepapers

Analysis of Monoclonal Antibody Digests using 2D-LC

November 26, 2013

This Application Note demonstrates the potential of comprehensive two-dimensional liquid chromatography using the Agilent 1290 Infinity 2D-LC Solution with DAD detection for the analysis of monoclonal antibody tryptic digests.

MFI for Particle Characterization of Biopharmaceuticals Today

November 26, 2013

Micro-flow imaging (MFI) is a sensitive, simple and automated method for the routine analysis of sub-visible particles and translucent protein aggregates. This technology provides particle size, count and morphology. Morphology provides the ability to discriminate a wide variety of particle types allowing you to monitor the change in both protein aggregates and other particles over time. This article reviews the application of MFI for monitoring protein aggregates and sub-visible particles in biopharmaceuticals.

N-Terminal Site-Specific PEGylation and Analytical-Scale Purification of PEG Lysozyme

November 26, 2013

In this study, hen egg white lysozyme was used as a model protein for PEGylation using N-terminal specific mPEG propionaldehyde (PEG aldehyde) in presence of cyanoborohydrate. A method for the analytical-scale purification of PEG lysozyme was developed using an Agilent 1260 Infinity Bio-Inert LC System and an Agilent Poroshell 120 SB-C18 column. Analytical-scale Fraction Collector with peak-based fraction collection was employed to collect the purified PEG lysozyme. The fractions were then re-analyzed by RP HPLC and SEC to demonstrate the homogeneity of the purified PEG conjugate.

Separation of Impurities in a Single Step using a Mixed-Mode Chromatography Media

October 29, 2013

MPC™ media is a versatile mixed-mode chromatography media with unique separation properties for multiple polishing applications at process scale. Combined properties of hydroxyapatite and fluoroapatite provides superior clearance performance.

Does Tween 20 Affect Monoclonal Antibody Separation?

October 29, 2013

Tween 20 has various beneficial properties for biological analysis, such as stabilizing proteins, solubilizing protein membranes, and preventing nonspecific binding of primary and secondary antibodies. Therefore, Tween 20 is often present in samples of monoclonal antibodies that require analysis using techniques such as SEC. This app note investigates whether the presence of Tween 20 detergent directly in the sample and in the eluent during multiple injections of an IgG sample onto an Agilent Bio SEC column affects the analysis or the columns.

A Novel Affinity Protein A Column for Monoclonal Antibody (MAb) Titer Analysis

October 29, 2013

The Thermo Scientific™ MAbPac™ Protein A column is a high-performance affinity chromatography column specifically designed for the determination of monoclonal antibody concentration in harvest cell culture. The nonporous, hydrophilic stationary phase enables fast and accurate MAb titer analysis. The ability to collect the IgG fraction during the HPLC analysis allows the analyst to characterize the IgG charge variants using a novel pH gradient approach.

N-Terminal Site-Specific PEGylation and Analytical-Scale Purification of PEG Lysozyme

October 29, 2013

Analytical-scale purification of PEG lysozyme was developed using an Agilent Bio-LC and Poroshell column. PEGylated lysozymes were re-analyzed by SEC and RP HPLC. The results indicated that purified PEG lysozyme was homogenous.

Minimizing the risk of mycoplasma contamination

September 1, 2012

Mycoplasma contamination can have a major harmful impact on the biopharmaceutical manufacturer. This application note discusses how 0.1 micron filtration can protect cell culture media from mycoplasma contamination without significantly slowing down processing.

Sanitization of a Process Chromatography Column

September 1, 2012

Process Chromatography columns must provide a very high level of cleanability to meet the requirements of various regulatory agencies. This study details the sanitary design and cleaning procedure of the Bio-Rad InPlace column.

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