Bio-Techne Application Notes

  1. 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.

  2. 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.

  3. 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.

  4. Apparent Molecular Weight On CE-SDS And SDS-PAGE 1/22/2021

    This Technical Note highlights relevant peer-reviewed publications that address factors for comparing molecular weight between CE-SDS and SDS-PAGE.

  5. Accurately Quanitfy Capsid Protein Ratios

    Read how comprehensive monitoring of VP1, VP2, and VP3 protein concentrations and their molar ratios is an effective tool to ensure initial optimization and consistent quality of the final AAV gene therapy products.