INSIGHTS ON DOWNSTREAM MANUFACTURING
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ACQUITY And XBridge Premier Protein SEC 250 Å Columns: A New Benchmark In Inert SEC Column Design
We demonstrate the performance of a new column technology designed to provide a holistic solution to the problems of undesired secondary interactions in SEC.
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Innovation Standardized – Bioseparation Methods For Biotherapeutics
Discover the most impactful standards in liquid chromatography (LC) for biotherapeutics. The standardizations include methods, columns, standards, and robustness.
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Performance Stability Of CORTECS 2.7 μm Columns Following Repeated Injections Of Precipitated Plasma
We review a column made using optimally packed solid-core particles. These columns are designed to tolerate repeated injections of minimally processed samples, while maintaining assay performance.
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Improvements In Recovery, Reproducibility, And Matrix Effects With A Novel Solid Phase Extraction Sorbent
In this study we review a successful next generation reversed solid-phase extraction (SPE) product that produces cleaner extracts with simpler protocols and faster processing time.
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Selecting A Reversed-Phase Column For The Peptide Mapping Analysis Of A Biotherapeutic Protein6/30/2022
In this study we review reversed-phase (RP) column selection considerations for peptide mapping applied to the routine characterization and analysis of biotherapeutic proteins.
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A Look At Column Reproducibility: Analysis Of Endogenous Steroid Hormones In Serum6/30/2022
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 Assays6/30/2022
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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Achieving Equivalent Results When Transferring Methods While Using Different Vendor’s Equipment6/29/2022
We demonstrate method transfer and migration between instruments that 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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A Mixed-Mode Approach - Alternative To A Three-Step mAb Purification Process6/29/2022
We present a two-step purification approach using Protein A Resin followed by a calcium affinity cation exchange media resulting in yields similar or better recovery and purity than a traditional three-step process.
DOWNSTREAM MANUFACTURING SOLUTIONS
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MaxPeak™ Premier Columns utilize MaxPeak high performance surfaces that are designed to increase analyte recovery, sensitivity, and reproducibility by minimizing analyte/surface interactions that can lead to sample losses.
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Waters series of chromatography columns and standards offer scientists the diverse range of chromatographic selectivities needed to help characterize today's biotherapeutics and biosimilars.
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The new Thermo Scientific™ DynaChrom™ Chromatography System marks our entry into single-use downstream purification and is designed to meet the needs of process scale-up and cGMP manufacturing.
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Through our global network, PCI provide comprehensive sterile fill-finish services from development through clinical to large scale commercial manufacturing, a seamless end-to-end solution delivering true speed to market.
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With more than twenty years of experience in freeze-drying bulk products, PCI is able to efficiently and expertly handle large-scale bulk lyophilization, harvesting, and packaging of your medical device, drug intermediate or API.