Downstream Processing Whitepapers - BioPharm International

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Downstream Processing Whitepapers

Development of Robust Charge Heterogeneity Assays using DOE

August 27, 2013

Develop robust charge heterogeneity assays using Design of Experiment (DOE). Utilizing imaged cIEF and DOE provides efficient and rapid method development and reduces assay failure. This application note provides a step-by-step process for the successful application of DOE tools with the iCE3.

Improving Aggregate Removal from Monoclonal Antibody Feed Using High Resolution Cation Exchange Chromatography

August 27, 2013

Nuvia™ HR-S media is a new cation exchanger designed for high resolution of closely related product impurities such as aggregates. It delivers excellent resolution with a final aggregate content of < 0.3% and a high recovery of > 80% from a heterogeneous feed of monoclonal antibody aggregates and monomer. Aggregate content and recovery in the eluate were shown to be a function of the target conductivity measured at the end of collection

TOYOPEARL GigaCap® DEAE-650M Preserving Resolution at Increased Protein Loads

April 30, 2013

TOYOPEARL GigaCap DEAE-650M, a very high capacity anion exchange resin for process scale chromatography, offers chromatographers a combination of binding capacities greater than 150 g/L while maintaining peak resolution.

Liposome Characterization by FFF-MALS-QELS

April 30, 2013

Liposomes are made of lipid bilayers and are often used in drug delivery by encapsulating the core with therapeutic drugs. During liposome research, formulation, manufacturing and quality control, it is of great importance to monitor liposome size and encapsulation. Field flow fractionation (FFF) with the concomitant use of Multi-Angle Light Scattering (MALS) and Quasi-Elastic Light Scattering (QELS, aka dynamic light scattering) is an ideal tool for such characterization.

Tosoh - Hydrophobic Interaction Chromatography: Effects of Mixed Electrolytes on Protein Separations

January 27, 2014

Tosoh - Hydrophobic Interaction Chromatography: Effects of Mixed Electrolytes on Protein Separations

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.

ProteinSimple - Comparability study of manual and automated particle characterization using MFI

September 24, 2013

Sub-visible particle analysis for biopharmaceuticals can now be automated with Micro-Flow Imaging ( MFI). MFI provides sensitive detection of translucent protein aggregates and other sub-visible particles. This case study from Takeda describes the transfer of a manual method to an automated format.

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