May 12, 2015
BioPharm International
The aggregation of biopharmaceuticals is a complex process. For efficient analysis, it’s essential to carefully select orthogonal methods to minimize gaps in the data. This article discusses advantages and disadvantages of specific methods.
Apr 13, 2015
BioPharm Bulletin
Use of ScreenExpert RoboColumns for high-throughput study of loading conditions on HyperCel™ STAR AX and MEP HyperCel Sorbents for mAb purification in flow-through mode.
Mar 25, 2015
BioPharm International
Design of Experiments (DoE), also called experimental design, is a statistical approach to process development that has gained wide acceptance in the biopharmaceutical industry. DoE is used to reduce development costs by speeding up the design process and to optimize the parameters of a particular step in the manufacturing process. The data presented here demonstrate the optimization of the CaPure-HA elution using a DoE approach.
Mar 23, 2015
BioPharm International
N-glycan sample preparation can now be completed, from glycoprotein to a ready-to-analyze sample, in just 30 minutes when using the sensitivity enhancing RapiFluor-MS labeling reagent.
Mar 16, 2015
BioPharm International
Understanding the factors that influence a metabolomics study and strategies to reduce biochemical and chemical noise .
Mar 09, 2015
BioPharm International
Unique analytical challenges surface because antibody drug conjugates (ADCs) are more hydrophobic than their parent monoclonal antibodies (mAbs). In this study, we investigate the feasibility of using a non-toxic ADC model with a Yarra™ 3 μm SEC-3000 column for aggregate analysis.
Jan 25, 2015
BioPharm International
We present a fully integrated HILIC UPLC workflow that is carried out with a compliant-ready platform featuring UPLC glycan columns, UPLC instrumentation with an FLR detector, and UNIFI informatics that includes the Glycobase Database of Glucose Unit (GU) values for analyzing labeled, released glycans. This workflow supports sample preparation using the new GlycoWorks RapiFluor-MS N-Glycan Kit. The Waters Biopharmaceutical Platform Solution with UNIFI enables laboratories to perform routine biotherapeutic glycan analysis with greater speed, accuracy, and consistency than by using disparate instruments and processes.
Jan 20, 2015
BioPharm International
A variety of column dimensions in terms of internal diameter and length are used by scientists 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 and to make the production as efficient and cost effective as possible. Here, we show that resin performance and productivity can be maintained at a constant linear velocity when going from a taller, thinner column to a shorter, wider column packed with a similar volume of resin.
Dec 02, 2014
BioPharm International
This whitepaper will focus on advantages of using the Waters Biopharmaceutical Platform Solution with UNIFI Software to assess, monitor, and compare these critical quality attributes of innovator and biosimilar biopharmaceuticals. We will look beyond the high-resolution UPLC/QTof MS data gained during an analysis, to how informatics can facilitate a better understanding of the similarities and differences between an innovator and a biosimilar product.
Dec 01, 2014
A simple, rapid and sensitive method for determination of raloxifene (RAL) and metabolites in human plasma, which outlines effective extraction, reversed-phase LC separation and detection on a triple quadrupole mass spectrometer.