Drug Development Applications & Studies
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A Look At Column Reproducibility: Analysis Of Endogenous Steroid Hormones In Serum
6/30/2022
Having reproducible columns is critical for the success of batch to batch testing of stationary phases, as well as ensuring lifelong performance for the assay.
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Increasing Chromatographic Performance Of Acidic Peptides In RPLC-MS-based Assays
6/30/2022
We demonstrate how to increase productivity in the lab and mitigate risk through increased reproducibility, recovery, and robustness of assays performed in the development and manufacturing of biopharmaceutical drug products.
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Successfully Transfer Methods While Using Different Vendor’s Equipment
6/29/2022
Successfully replicates methods, producing equivalent chromatographic separation and analytical results generated by the method to the results obtained on the comparable LC systems.
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Examining Column Reproducibility During Method Development In Clinical Labs
6/28/2022
In this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.
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Perform HPLC Method Transfer Between Analytical Testing Equipment
6/27/2022
It is essential for the analytical laboratories to successfully transfer analytical methods. We present a transfer of the HPLC method for related substances analysis of metoclopramide HCl.
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Risk-Based Approach Supports Migration Of Legacy Methods For Eurofins BPT Toronto
6/27/2022
Eurofins Bio-Pharma Product Testing applied a modern, risk-based approach to method migration and was able to understand the impact of introducing state-of-the-art technology for their legacy methods.
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Overcoming Method Transfer Challenges
6/24/2022
Although development and quality control labs might be slow to replace existing technologies, modernization can benefit legacy methods and future development activities.
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Deliver Product Quality, Enhance Productivity In CHO-K1, CHO-S Cells
6/20/2022
Early identification of a robust, commercially available, optimized platform medium and cell line–specific feed could be the keys to achieving strong productivity and delivering product to market more rapidly.
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The Future Of Plug-And-Play Large-Scale Viral Vector Manufacturing
6/8/2022
Explore AAV-based gene therapy production to manage adherent and suspension processes, and new approaches for creating large-scale AAV production that can meet any product specification.
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Rapid Mass Confirmation And Purity Analysis Of Biotherapeutics
5/16/2022
Here, we report the development of an application that streamlines LC-MS data acquisition, data intact mass processing and reporting of results suitable for a compliance-ready environment.