Whitepapers - BioPharm International

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Whitepapers

Size-Exclusion Ultra Performance Liquid Chromatography Method Development for the Analysis of the Degradation Products of the Trastuzumab Antibody

August 28, 2012

This application presents the impact that mobile phase composition (pH and ionic strength) can have on this separation. Additionally, we will discuss some of the primary considerations necessary for the successful transfer of a developed SE-UPLC method.

Capacity Planning in Biomanufacturing

July 31, 2012

In this whitepaper we examine the key metrics involved in capacity decisions for biopharmaceutical operations. We demonstrate how to model demand as well as existing and new supply capacity in the 1-10 year planning horizon. Using simple models of risk and variability, we demonstrate how integrated ‘supply-demand’ models can be used to accurately predict and prepare manufacturing capacity for the pipeline.

Innovative Multi-Loci Based Composition Analysis for Microbial ID.

July 31, 2012

PLEX-ID is a fully integrated system design for routine microbial screening and identification. This note outlines the process for base composition analysis, database creation and reporting used by this system.

Economic Analysis of Single-Use TFF

July 31, 2012

Using a pre-sanitized disposable TFF membrane in the DSP of biopharmaceuticals makes it possible to reduce labor by 50% and buffer/water usage by 75%. In addition, it can increase productivity by more than 45%. This economic model compares the costs of reusable and single-use TFF in biopharmaceutical applications.

QA/QC of monoclonal antibodies: High-resolution peptide mapping using the Agilent 1260 Infinity Bio inert Quaternary LC and Agilent 1290 Infinity LC Systems

July 31, 2012

This Application Note describes an application solution for peptide mapping of a monoclonal antibody using the Agilent 1260 Infinity Bio-inert Quaternary LC System and proves the reliability of the solution. The bio-inertness and corrosion resistance of the instrument coupled with simple and reproducible methods make this solution particularly suitable for the QA/QC analysis of monoclonal antibody for the biopharmaceutical industry. The power range of the 1290 Infinity LC System (pressure versus flow) overcomes the challenge of increased back pressure caused by smaller particles and longer columns.

Development of a High Capacity, Mixed-Mode Resin for High Conductivity mAb Feedstocks

July 31, 2012

The paper will describe the key performance attributes of TOYOPEARL MX-Trp-650M Mixed-Mode resin and its ability to retain protein capacity even when encountering elevated feedstock or buffer conductivities.

Qualify and Quantify PEG and PEGylated Biopharmaceuticals

July 31, 2012

Quantify both the PEGylated product and residual PEGylation reagents in less than 20 min using a 2D-LC configuration. On-line software controlled sample preparation allowed for monitoring the degree of PEGylation.

Analysis of phosphate compounds with the Agilent 1260 Infinity Bio-inert Quaternary LC System

June 25, 2012

With the Agilent 1260 Infinity Bio-inert Quaternary LC System, phosphate compounds can be analyzed without any issues regarding the formation of phosphate-iron complexes found with stainless steel systems.

Size-Exclusion Ultra Performance Liquid Chromatography for the Analysis of Covalent High Molecular Weight Insulin

June 25, 2012

Presented in this application are the advantages that may be realized using a 125Å pore size, sub-2-µm ethylene-bridged hybrid (BEH) silica packing material and Waters UltraPerformance Liquid Chromatography (UPLC) instrumentation for this traditional analysis. Among these advantages are faster run times, higher sensitivity, and higher resolving separations of insulin and covalent insulin HMW, while at the same time greatly reducing acetonitrile containing waste-stream volumes.

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