Whitepapers - BioPharm International

ADVERTISEMENT

Whitepapers

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.

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.

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.

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.

Managing Cell-Based Potency Assays – from Development to Lifecycle Maintenance

June 1, 2012

Characterization of a biological product, which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities, is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).

Quantitative Aspects of UPLC Peptide Mapping

July 23, 2007

Throughout the development of a biopharmaceutical protein, peptide mapping is used to demonstrate genetic stability and to confirm the intergrity of the protein. This whitepaper focuses on the quantitative aspects of UPLC peptide mapping with UV detection.

Validation Week Conference Brochure

September 24, 2013

Validation Week Conference Brochure

ADVERTISEMENT

ADVERTISEMENT

Click here