Outsourced Pharma App Notes & Case Studies

  1. Characterization Of Host Cell Proteins By Liquid Chromatography - Mass Spectrometry 2/26/2024

    Explore an established liquid chromatography – tandem mass spectrometry (LC-MS/MS) method for characterization of residual HCPs in monoclonal antibody (mAb) products.

  2. Streamlining The Integrity Testing Process – From Test To Report 2/22/2023

    Discover a digital transformation solution that provides first of its kind data analytics for filter integrity testing. The software helps operators and supervisors reduce time lost through review processes.

  3. Biacore™ SPR Systems For Titer Analysis Of Adeno-Associated Virus 10/13/2022

    We describe the performance of two assays for titer analysis of adeno-associated virus (AAV), serotype 2 and serotype 5, based on surface plasmon resonance (SPR).

  4. Lipid Nanoparticle Compositional Analysis By UHPLC-CAD 6/30/2023

    Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.

  5. Apheresis Variability Control In Cell Therapy Manufacturing 7/25/2022

    Explore our best practices for apheresis collection and obtention of enriched product for cell therapies.

  6. Peptide Mapping Of AAV By LC-MS 9/29/2022

    View the results generated from an internal study where peptide mapping of two different AAV serotypes – AAV8 and AAV9 – was performed by LC-MS.

  7. Recombinant Protein Purification Optimization With HIC 5/1/2023

    A step-by-step high-throughput process development (HTPD) workflow to determine the optimal resin and initial conditions for hydrophobic interaction chromatography (HIC).

  8. Engineering Approaches To Respiratory Drug Delivery 5/27/2022

    Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.

  9. Secondary Packaging Strategies For Commercial Launch Of A Biologic 8/17/2022

    A commercial packaging solution can be the first and enduring impression that a sponsor company makes on a patient, and its suitability can impact a biologic’s commercial success.

  10. Capture Of Bispecific Antibodies And Removal Of Product-Related Impurities 11/17/2022

    Many antibody variants are prone to aggregation or to forming product-related impurities. Explore the application of a resin with novel selectivity to purify challenging entities.