Bio-Techne Application Notes

61. Evaluating Stability Of Biosimilar mAbs With Micro-Flow Imaging 1/28/2021

    Here we show how we use MFI to evaluate the stability of two therapeutic monoclonal antibodies, trastuzumab and bevacizumab, and their biosimilars.

62. Monoclonal Antibody Characterization By CE-SDS: Maurice Versus LabChip 1/27/2021

    Accurate reporting of a biologic’s critical quality attributes (CQAs) is required for its commercialization. In the case of monoclonal antibodies (mAb), CQAs dealing with mAb fragmentation and post-translational modifications like glycosylation, are often inherent in the complex composition of a protein therapeutic. In this application note we compare two systems under reduced and non-reduced conditions, and evaluate CE-SDS separation using a reference mAb from the National Institute of Standards and Technology (NIST).

63. Application Of Maurice CE-SDS For Biopharmaceutical QC Workflows 1/27/2021

    Protein identity, stability and purity are critical quality attributes of biopharmaceutical molecules that need to be closely monitored. Capillary electrophoresis (CE)-based methods can be efficiently applied for analytical quality control (QC) testing and provide a number of key advantages. Analysts performing CE may use an internal standard (IS) during batch runs for various reasons, including an effort to reduce sample injection variability, to correct for discrepancies in migration time and/or as a mobility marker. In this application note, Maurice™ CE-SDS is evaluated on assay performance and method validation characteristics that are important for QC analytical testing using three reference molecules.

64. Powering Up Maurice With Waters™ Empower® Software 1/27/2021

    Maurice is your one-stop cIEF and CE-SDS platform that delivers high-resolution, reproducible identity, purity, and heterogeneity analysis of biotherapeutic proteins. In this application note, we’ll take you through the data acquisition and data analysis for a monoclonal antibody, using an Empower® controlled Maurice.

65. Enhanced CE-SDS Analysis With Maurice's CE-SDS PLUS System 1/26/2021

    CE-SDS is a standard methodology for characterization of biotherapeutic proteins and confirmation of product purity. Maurice and Maurice S. deliver this analysis in an easy-to-use format that significantly simplifies your workflow and reduce hands-on time and the chance of user error. In addition the PLUS system preserves the same features, and in addition enables enhanced sample stability and data consistency throughout a batch.

66. Comparing SDS-PAGE With Maurice CE-SDS For Protein Purity Analysis 1/26/2021

    This application note compares Maurice CE-SDS with SDS-PAGE in parallel and reveals the advantages of Maurice CE-SDS over SDS-PAGE for routine product purity characterization.

67. icIEF Analysis Of Adeno-Associated Virus (AAV) Proteins For Gene Therapy 1/25/2021

    As with all therapeutic drugs, product characterization is of utmost importance in order to ensure drug safety and stability. For gene therapies, this includes characterizing the delivery vector before the drug is packaged. In this study, we demonstrate how imaged-capillary isoelectric focusing (icIEF) can be used to characterize the charge heterogeneity of AAV vectors to ensure product stability and identity.

68. Characterization Of AAV Vector Proteins Using Maurice CE-SDS 1/25/2021

    To support the rise of AAV vectors in the clinic, solutions that afford robust quality control assays are essential for GMP, meeting regulatory requirements, and ensuring clinical quality, safety, and consistency.

69. Determining Residual Bead Count: Application Of Micro-Flow Imaging To CAR T-Cell Manufacturing 1/25/2021

    Residual bead count is typically determined manually by the naked eye and microscopy. But this approach is highly limited in its ability to accurately discern beads from cells and other potential in-process impurities, resulting in reporting uncertainties that risk regulatory approval. In this application note, you’ll see how automation via image-based Micro-Flow Imaging™ (MFI) technology gets you the quantitative and morphological data you need to have confidence in distinguishing between beads, T cells or other potential contaminants.

70. CE-SDS Analysis Of A NISTmAb Reference Standard Using Both Maurice And The SCIEX PA 800/PA 800 Plus 1/22/2021

    Regulatory agencies require that all biopharmaceutical companies monitor critical quality attributes for any monoclonal antibody therapeutic product. CE-SDS is a commonly used method as it provides purity and identity information required by the FDA. Regulatory agencies require that all biopharmaceutical companies monitor critical quality attributes for any monoclonal antibody therapeutic product. CE-SDS is a commonly used method as it provides purity and identity information required by the FDA.