Whitepapers - BioPharm International

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Whitepapers

5 Rules of Sensor Placement in Validation/Mapping Applications

April 29, 2014

In today's global economy, drugs, biotechnology, and medical devices are shipped all over the world. To ensure these temperature-sensitive products are stored correctly, new or revised regulations have been developed in many key regions, including China, Europe, and the US. A universal practice to satisfy the new Good Distribution Practice (GDP) regulations is to perform mapping studies to qualify storage areas. Two common questions in mapping studies are: 1) where to place sensors, and 2), how many sensors to use. This article discusses five rules to apply when creating a rationale for sensor placement in mapping studies.

Detailed Aggregation Characterization of Monoclonal Antibodies

April 29, 2014

This Application Note shows detailed size exclusion analysis of monoclonal antibodies and their aggregates using the Agilent 1260 Infinity Multi-Detector Bio-SEC Solution.

Direct Analysis of Opioids and Metabolites from Whole Blood Using Ostro Sample Preparation Plates Combined with UPLC/MS/MS for Forensic Toxicology

April 29, 2014

The analysis of natural and synthetic opioid drugs continues to be an important aspect of forensic toxicology. A substantial percentage of arrests and/or deaths are attributed to the misuse or abuse of narcotic pain relievers such as oxycodone and hydrocodone, as well as the illegal opiate, heroin.

10-Minute Charge Heterogeneity Analysis

December 27, 2013

Platform methods, high resolution, and ease of use have made the iCE system the gold standard for protein charge heterogeneity characterization for biopharmaceuticals. At 15-18 minutes per sample, iCE methods are already fast and simple but now they are even better. In this application note we describe a high throughput 10-minute charge heterogeneity analysis method and performance improvements that provide automated analysis of 100 samples at a time.

Analysis of Monoclonal Antibody Digests using 2D-LC

November 26, 2013

This Application Note demonstrates the potential of comprehensive two-dimensional liquid chromatography using the Agilent 1290 Infinity 2D-LC Solution with DAD detection for the analysis of monoclonal antibody tryptic digests.

MFI for Particle Characterization of Biopharmaceuticals Today

November 26, 2013

Micro-flow imaging (MFI) is a sensitive, simple and automated method for the routine analysis of sub-visible particles and translucent protein aggregates. This technology provides particle size, count and morphology. Morphology provides the ability to discriminate a wide variety of particle types allowing you to monitor the change in both protein aggregates and other particles over time. This article reviews the application of MFI for monitoring protein aggregates and sub-visible particles in biopharmaceuticals.

N-Terminal Site-Specific PEGylation and Analytical-Scale Purification of PEG Lysozyme

November 26, 2013

In this study, hen egg white lysozyme was used as a model protein for PEGylation using N-terminal specific mPEG propionaldehyde (PEG aldehyde) in presence of cyanoborohydrate. A method for the analytical-scale purification of PEG lysozyme was developed using an Agilent 1260 Infinity Bio-Inert LC System and an Agilent Poroshell 120 SB-C18 column. Analytical-scale Fraction Collector with peak-based fraction collection was employed to collect the purified PEG lysozyme. The fractions were then re-analyzed by RP HPLC and SEC to demonstrate the homogeneity of the purified PEG conjugate.

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.

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.

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