Whitepapers - BioPharm International

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Whitepapers

Separation of Impurities in a Single Step using a Mixed-Mode Chromatography Media

December 27, 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.

Affinity Removal High Abundant Proteins in Human Plasma

December 27, 2013

This Application Note describes the depletion of high abundant proteins from plasma using the Agilent Multiple Affinity Removal System coupled with the Agilent 1260 Infinity Bio-inert Quaternary LC.

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.

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).

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