Whitepapers - BioPharm International



TOYOPEARL GigaCap® Cation Exchange Resins for Aggregate Removal from Monoclonal Antibodies

August 26, 2014

Aggregate removal is a pivotal process step in the purification of monoclonal antibodies (mAbs). The removal of soluble, non-precipitated mAb aggregates is highly challenging due to their close physical and chemical similarity to the drug product itself. Ion exchange chromatography (IEC) has long been used as an effective means of removing process impurities from biological drug products. Cation exchange chromatography (CEX), in particular, has shown to be effective in separating mAb monomer from dimers and higher order aggregates. In this paper, the removal of mAb dimer and higher order aggregates from mAb monomer using TOYOPEARL GigaCap cation exchange resins is demonstrated.

Determination of Protein Molecular Weight and Size

July 29, 2014

This application note shows the determination of protein molecular weight and size, together with linear quantification using the Agilent 1260 Infinity Multi-Detector Bio-SEC Solution.

Rapid Separation and Mass Spectrometry Detection of Intact Protein Samples Using Monolithic Capillary Columns

July 29, 2014

This application note demonstrates the rapid separation of a wide mass range of peptides and proteins using a reversed-phase monolithic column with both UV and mass spectrometry (MS) detection. The separation is conducted on Thermo Scientific™ ProSwift™ RP-4H columns using conventional water/acetonitrile-based eluents. These simple, straightforward methods can be used to optimize chromatographic separations for analysis time, resolution, and MS detection especially for top-down proteomics.

Analysis and Control of Particles in Biopharmaceuticals

July 29, 2014

A key challenge for companies developing biologics is the control of particles in the final formulation. Managing product contamination from intrinsic and extrinsic particles, and protecting patients from the associated risk, is increasingly important.

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.

TOYOPEARL NH2-750F Aggregate Removal from Monoclonal Antibodies

June 24, 2014

The drive to reduce the manufacturing costs for biological therapeutics have increased the demands placed on downstream unit operations to the point where a single processing step is expected to accomplish a multitude of purification objectives. Where anion exchange resins have traditionally been used to remove DNA, endotoxin, and as a viral clearance step in the purification of monoclonal antibodies (mAbs), new ligand chemistries make it possible for anion exchange chromatography to do more. In the following paper, TOYOPEARL NH2-750F, a salt tolerant anion exchange resin from Tosoh Bioscience, is shown to be able to remove mAb dimer and higher order aggregates from mAb monomer.

Analysis of Synthetic Cannabinoids from Whole Blood for Forensic Toxicology Using Ostro Sample Preparation Plates and CORTECS UPLC Solid-Core Columns

June 24, 2014

Analysis of Synthetic Cannabinoids from Whole Blood for Forensic Toxicology using Ostro Sample Preparation Plates and CORTECS UPLC Solid-Core Columns

Simple and Sensitive Sub-visible Particle Classification for Biopharmaceuticals with Micro-Flow Imaging

June 24, 2014

Micro-Flow Imaging (MFI) provides accurate and sensitive detection of sub-visible particles and protein aggregates in biopharmaceuticals. Even better, MFI can classify particle populations. This application note takes you through how easy it is to develop custom particle filters to get more accurate and sensitive discrimination between the particles in your protein formulations.

Quantifying Economic Benefits of Automated Rapid Detection

May 26, 2014

Most pharmaceutical manufacturers have adopted lean initiatives within their production areas in order to survive and thrive in an increasingly competitive economy. But an often-overlooked area, quality control, has been left untouched by lean initiatives. Pharmaceutical companies can achieve maximum efficiency by evaluating and streamlining microbial quality control procedures using lean principles to automate and accelerate the work microbiologists have traditionally done manually with a rapid microbial method. Learn key components to include in a business case.



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