Whitepapers

Feb 03, 2016
BioPharm International
Formulations scientists are expected to do a lot more with less – more constructs, higher concentrations, less volume. In this educational whitepaper, case studies from literature will be presented and a powerful tool - the UNit - which can measure multiple protein stability parameters with a lot less sample will be presented and discussed.
Jan 12, 2016
BioPharm International
FormPrep automates buffer preparation, buffer exchange, and protein concentration in one easy-to-use system. This application note compares critical parameters including pH accuracy, protein recovery, and protein stability from multiple buffer exchange methods.
Jan 07, 2016
BioPharm International
The Note describes a simple and sensitive method for the quantitation of aggregates in a biotherapeutic mAb and antibody drug conjugate (ADC).
Dec 16, 2015
BioPharm International
When developing biotherapeutics, the characterization of proteins is required to obtain information on the molecule’s attributes. The analytical tools to achieve this goal consist of a range of chromatographic techniques, such as reversed-phase, ion-exchange, and size-exclusion chromatography. Each of these techniques provide complementary information on the protein. Five types of analysis are common for all biotherapeutics: analysis of hydrophobicity and charge variants, quantitation of aggregates and fragments, peptide mapping, and glycan profiling. In this whitepaper, we will discuss the development of liquid chromatography methods that are optimized to meet the requirements of modern biotherapeutics characterization laboratories. Emphasis will be given in guiding the selection of the proper column characteristics and instrument settings.
Nov 18, 2015
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TSKgel UP-SW3000 columns are 2 µm SEC columns designed for the analysis of monoclonal antibodies and other biopharma products and can be used on both HPLC and UHPLC systems. Higher resolution can be achieved for the separation of antibody monomers, dimers and higher order aggregates with a TSKgel UP-SW3000 column compared to a competitor UHPLC column. In addition, a TSKgel UP-SW3000 column yielded very low percent relative standard deviation (%RSD) for peak parameters including retention times, peak asymmetry, and efficiency, demonstrating the exceptional reproducibility of this column versus a competitor UHPLC column.
Nov 18, 2015
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Characterizing the viscosity of biologic formulations is a critical part of formulation development as the viscosity can have an impact on bioprocessing as well as final administration of the biologic. The UNit with the optional 445 nm laser enables the relative viscosity measurement and retains the 266 and the 473 nm lasers, thus retaining its capability to simultaneously measure conformational stability and aggregation propensity of samples. In this application note, we demonstrate the use of the UNit with the optional 445 laser in combination with a fluorescent molecular rotor to screen relative viscosities of samples in a high throughput manner.
Oct 28, 2015
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In this whitepaper, we will review peptide LC/UV/MS data generated using an Waters Empower 3 Software with an ACQUITY UPLC H-Class System configured with a TUV optical detector and the ACQUITY QDa Mass Detector. This trusted platform enables automation of LC/UV/MS data collection, processing, and reporting for both discovery/development and regulated development/QC organizations. With minimal cost and effort, organizations can quickly strengthen their biotherapeutic development processes, while reducing the burden on core MS laboratories, resulting in enhanced productivity and streamlined laboratory operations.
Oct 21, 2015
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Rapidly measure multiple protein stability-indicating parameters at once. Measure thermal melting point and onset of aggregation temperature simultaneously, 48 samples at a time, with the UNit.
Sep 25, 2015
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Bang out your best biologic: perform same-time Tm and Tagg, use 9µl of sample, run 144 samples a day, 7 applications. Get your hands on the UNit, the only multiplex protein stability system.
Sep 24, 2015
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From polyclonal antibodies to monoclonals using hybridomas to fully synthetic human antibody libraries, antibody technology has made great strides! A review of the progress and the HuCAL® technology is presented.
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