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Whitepapers

Expansion of Stem Cells in Single-Use Bioreactors

October 28, 2014

The following application note describes the successful cultivation of human pluripotent stem cells in suspension culture using Eppendorf BioBLU® 0.3 Single-Use Vessels in a DASbox® Parallel Mini Bioreactor System.

Sensitive and Reproducible Glycan Analysis of Human Immunoglobulin G

October 28, 2014

The sensitive and reproducible analysis of N-linked glycans of human immunoglobulin G is demonstrated, using an Agilent 1260 Infinity Bio-Inert Quaternary LC, with a novel HILIC column and fluorescence detection.

Advanced HPLC Size-Exclusion Chromatography for the Analysis of Macromolecular Proteins Using 3.5 µm Ethylene Bridged Hydrid (BEH) Particles

October 28, 2014

This application note highlights the performance characteristics of both the 200Å and 450Å pore-size versions of Waters new XBridge Protein BEH SEC Columns, designed for the separation of macromolecular proteins, with respect to resolution, column-to-column reproducibility, and column stability.

MFI for Particle Characterization of Biopharmaceuticals Today

October 28, 2014

New biopharmaceutical regulations require thorough sub-visible particle characterization. Learn how MFI’s direct particle detection addresses this requirement, through sensitive quantification of particle size and shape for contaminants, including protein aggregates.

CaPure-HA Resin for Aggregate Removal from Monoclonal Antibodies

October 28, 2014

Scientists in the field of process chromatography methods development are constantly on the lookout for better and more selective ways to remove aggregates and other process-related impurities from monoclonal antibody monomer. The data presented in the following paper demonstrate the capabilities of CaPure-HA to remove degradation products, dimer, and higher-order aggregates from the monomer of a protein A purified IgG1 monoclonal antibody.

High-Throughput, High-Resolution mAb Analysis with Small Particle Size HPLC Columns

October 28, 2014

High-throughput applications of the Thermo Scientific™ MAbPac™ SCX-10 column, showing acidic and basic variant analysis, including mAb lysine truncation variant characterization. Ruggedness of the 3 μm small particle phase column is also demonstrated.

Minimizing Excipient Fluorescence Interference Using Handheld Raman

September 30, 2014

A study of commonly used pharmaceutical excipients concluded that 1064nm handheld Raman overcomes sample generated fluorescence, thus providing compound specific “signature” Raman peaks for more accurate identification.

Mammalian Virus Purification Using Ceramic Hydroxyapatite

September 30, 2014

Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.

PEGylated Protein Analysis by Size-Exclusion and Reversed-Phase UPLC

September 30, 2014

The first PEGylated biotherapeutic, pegademase, which is a bioconjugate of the bovine derived enzyme adenosine deaminase and 5 KDa molecular weight (MW) polyethylene glycol (PEG), was introduced in 1990. Pegademase is used for the treatment of individuals with severe combined immunodeficiency disease (SCID).

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