Application Notes & Case Studies

  1. Serialization And Aggregation Of Drug Products
    11/28/2018

    Pharma company finds a solution that allows the operator to conveniently assign the units from a lower packaging level (e.g., folding box) to a higher level (e.g., shipping cartons) and, in this way, to set up the hierarchical relationships (parent-child relationship) in the database.

  2. Quality Assurance Of Hotel Cosmetics
    11/28/2018

    Using checkweighers for 100% inline product control of bottles, jars and tubes.

  3. Efficient Track And Trace Solutions For International Pharmaceutical Company
    11/28/2018

    Serialization and aggregation solutions allows Swiss-based Acino Pharma serve its international customers quickly and reliably

  4. Container Closure Integrity Testing: Risks And Methods
    11/12/2018

    An overview of integrity tests where a high sensitivity are required to prevent the risks of stability failure of highly moisture sensitive drugs or the risk of biological ingress of sterile parenteral drugs.

  5. Multidimensional Scale-Up Of A Monoclonal Antibody Capture Step Contributes To Shortened Time To Market
    10/10/2018

    Fast and efficient process development and scale-up contributes to a shortened time to market. This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.

  6. Process-Economy Simulation Of mAb Capture Step With Protein A Chromatography Resin
    10/10/2018

    Calculation examples that highlight scenarios where the enhanced capacity and alkaline‑stability of MabSelect PrismA can provide process economic benefits to large‑scale mAb processing.

  7. Replace Dye Ingress With Mass Extraction To Mitigate Risks
    10/2/2018

    A major pharma company had a problem. Its manufacturing process engineers could not reliably verify that pouch packages were sealed properly. Product could potentially ship with questionable packaging.

  8. Use Of Sodium Hydroxide For Cleaning And Sanitization Of Chromatography Resins And Systems
    10/2/2018

    This application note examines these aspects of using sodium hydroxide as a cleaning and sanitizing agent.

  9. Lifetime Performance Study Of MabSelect™ PrismA During Repeated Cleaning‑In‑Place Cycles
    10/2/2018

    A demonstration of the long‑term chromatographic performance of MabSelect PrismA during repeated purification cycles using 0.5 M NaOH for CIP.

  10. Capacity And Performance Of MabSelect™ PrismA Protein A Chromatography Resin
    10/2/2018

    This application note demonstrates the binding capacity of MabSelect PrismA in comparison with its predecessor products for both polyclonal and monoclonal antibodies.