Whitepapers - BioPharm International

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Whitepapers

Are “Canned” Performance Qualification Protocols Ok?

February 25, 2014

What’s the quickest solution to a robust PQ of your environmental monitoring system: DIY or vendor supplied? This article discusses the keys to evaluating “canned” PQ documents from suppliers and options for creating your own protocols. Also, is skipping the PQ process an option? Learn more…

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.

Separating Beyond Question

December 27, 2013

ACQUITY QDa Detector is as intuitive as an optical detector, with the robustness to handle all of your analyses. Working in harmony with your chromatography, it is pre-optimized to work with your samples, without the sample-specific or user adjustments typical of traditional mass spectrometers.

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.

Monoclonal Antibody Purification with a High Capacity Protein A Resin

November 26, 2013

Protein A resins constitute a substantial cost in state-of-the-art mAb purification processes. Factors such as operating cycles, capacity, and mAb titer can have an impact on total costs associated with mAb purification. The purification of a monoclonal antibody from crude feed stock using TOYOPEARL? AF-rProtein A HC-650F, a high capacity protein A resin from Tosoh Bioscience, show that this particular high capacity protein A resin delivers highly pure antibodies at yields approaching 90%.

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.

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.

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.

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