INSIGHTS ON DOWNSTREAM MANUFACTURING

• 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.

• 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.

• 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.

• 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.

• Selecting A Reversed-Phase Column For The Peptide Mapping Analysis Of A Biotherapeutic Protein

  6/30/2022

  In this study we review reversed-phase (RP) column selection considerations for peptide mapping applied to the routine characterization and analysis of biotherapeutic proteins.

• 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.

• 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.

• Achieving Equivalent Results When Transferring Methods While Using Different Vendor’s Equipment

  6/29/2022

  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.

• A Mixed-Mode Approach - Alternative To A Three-Step mAb Purification Process

  6/29/2022

  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.