Whitepapers - BioPharm International

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Whitepapers

CaPure-HA Resin for Aggregate Removal from Monoclonal Antibodies

November 25, 2014

Scientists in the field of process chromatography methods development are constantly on the lookout for better and more selective ways to remove aggregates and other process-related impurities from monoclonal antibody monomer. The data presented in the following paper demonstrate the capabilities of CaPure-HA to remove degradation products, dimer, and higher-order aggregates from the monomer of a Protein A-purified IgG1 monoclonal antibody.

Analysis of Wine Using the NGC™ Chromatography System

November 25, 2014

In this study, we demonstrate the integration of an external reflective index detector, along with simultaneous monitoring of multiple optical signals, to expand the capabilities of the NGC system for the chromatographic identification and quantification of compounds in wine.

Time savings with simplified cell culturing

November 25, 2014

Application note describing how ReadyToProcess WAVE 25 bioreactor can help reduce hands-on time as much as 25% in fed-batch culturing, while delivering excellent culture performance.

Purification of a Monoclonal Antibody with TOYOPEARL® AF-rProtein A HC-650F at Various Bed Heights

November 25, 2014

Scientists use a variety of column dimensions in terms of internal diameter and length when developing a Protein A purification step for monoclonal antibody capture. Typical bed heights for Protein A columns used in a commercial manufacturing process are in the range of 15 to 20 cm to optimize throughput, yield, and recovery to make the production as efficient and cost effective as possible. Here, we show that altering column dimensions to favor a shorter, wider column will have no effect on resin performance when compared with a longer, narrower column of the same total volume.

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

November 25, 2014

This article provides an overview of cell-based potency assays intended for quality control. Topics covered include technical considerations during method development; phase appropriate qualification/validation and transfer strategy; as well as assay life-cycle management.

Cell Culture Media Identification with Handheld Raman

November 25, 2014

The new handheld Raman analyzer, Progeny, provides a nondestructive, reliable, and cost-effective method for analysis of complex cell culture media. Utilizing a 1064nm excitation wavelength source, Progeny minimizes fluorescence interference which is common problem in cell media analysis.

Process Transfer Excellence with Boehringer Ingelheim

November 25, 2014

This white paper will focus on the interaction and collaboration with external customers when transferring processes from a customer to one of Boehringer Ingelheim’s manufacturing sites.

Carbohydrates Analysis Application Notebook

November 25, 2014

The Carbohydrate Analysis Application Notebook consists of applications using HPAE-PAD for the analysis of glycans, carbohydrates in food and beverages, and carbohydrates in biofuels.

Multivariate Profiling as a Pivotal Tool in Identifying Critical Raw Materials that Rescue N-Linked Glycosylation Profiles

November 25, 2014

Over the past decade, notable advances in the characterization and control of post-translational modifications (PTMs) to enhance therapeutic properties have continued to drive the development of many next-generation biopharmaceuticals. It has been widely reported that the quality of secreted therapeutic proteins is dependent on the consistency of attached glycan moieties. Insufficient glycosylation potentially impairs efficacy and safety. Our particular interest lies in identifying critical raw materials that rescue N-linked glycosylation profiles of therapeutic proteins from selected high-producing clones. This study represents an important step towards establishing cGMP-ready chemically defined supplements that significantly and reproducibly adjust glycan moieties. In addition, the multivariate profiling process described here represents a pivotal tool in the upstream characterization of biopharmaceutical platforms.

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