Application Notes & Case Studies

  1. Leveraging Innovative Analytics To Ensure The Thermal Stability Of mAb Drug Products 9/23/2024

    Uncover how innovative Rapid Screening-Differential Scanning Calorimeter technology is enabling robust analysis and regulatory compliance by ensuring the thermal stability of antibody drug products.

  2. Maintain Sterility And Ease In CGT development, Including Cryopreservation 9/23/2024

    Sterile connectors streamline cell and gene therapy processes while maintaining sterility. By withstanding extreme temperatures and cryoprotectants, they can ensure product viability during cryopreservation.

  3. Extractables In Single-Use Systems Used In ADC Manufacturing 9/23/2024

    To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

  4. CDMO Accelerates Contract Manufacturing With Electronic Batch Records 9/18/2024

    A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

  5. Successful Method Migration Of The USP Quetiapine Fumarate Impurities Method 9/18/2024

    Successful method migration to a new HPLC system can be challenging. The gradient USP method for Quetiapine Fumarate Impurities was analyzed on two legacy HPLC systems and on modern technology.

  6. Analysis Of Atorvastatin As Per USP Monograph 9/18/2024

    The USP monograph of atorvastatin requires adherence to strict criteria for the assay analysis of atorvastatin. In this study, several strategies were implemented to meet the stipulated USP monograph criteria.

  7. HILIC Method Migration Part 2: Troubleshooting Peak Splitting Of Cetirizine 9/18/2024

    The system suitability solution sample from the cetirizine hydrochloride organic impurities USP monograph was used to assess the impact of the needle wash and needle wash design on HILIC separations.

  8. Analysis Of Azithromycin: System Performance Under Challenging Conditions 9/18/2024

    The USP monograph for Azithromycin Organic Impurities was chosen as a representative method. Explore the challenges of this method, and compare the results obtained across a number of different HPLC systems.

  9. 384-Well Microplate Time Resolved Fluorescence (TRF) Immunoassay 9/18/2024

    Examine how innovative sandwich ELISAs in a 384-well format can be utilized with a sensitive reader for high-throughput screening to quantify Human IgG and IFN gamma.

  10. Replicating An HPLC Method For Water-Soluble Vitamins: Part 1 9/18/2024

    The rising popularity of vitamin supplements necessitates ensuring product content accuracy. In this study, we demonstrate the ability to achieve the same quantitative results on legacy and newer HPLC systems.