Whitepapers

BioPharm International: Mar 23, 2015
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.
BioPharm International: Mar 16, 2015
Understanding the factors that influence a metabolomics study and strategies to reduce biochemical and chemical noise .
BioPharm International: Mar 09, 2015
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.
BioPharm International: Jan 25, 2015
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.
BioPharm International: Jan 20, 2015
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.
BioPharm International: Dec 02, 2014
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.
Nov 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.
Nov 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.
Nov 25, 2014
In this work, an AdvanceBio Peptide Mapping column is used to generate a rapid and highly efficient peptide map at a traditional LC system pressure. The column achieves substantial improvements in peptide mapping during very fast run times and low system pressures, while still maintaining high, peak-performance efficiency.