White Papers

  1. Container Closure Integrity Testing Of Intravenous Bags
    8/21/2018

    A non-invasive, non-subjective solution that is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.

  2. Performance Validation: HPAPI Containment Testing in A Risk-Based Era
    8/20/2018

    Key considerations linked to containment performance testing, data collection methods and the interpretation of results.

  3. Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment
    8/3/2018

    The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.

  4. Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production
    8/3/2018

    Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.

  5. Redefining Fast Melt For Pharma
    7/31/2018

    Achieving high drug load with rapid dispersion using 3D printing.

  6. The Hidden Value Of Instrument Manufacturers
    7/2/2018

    Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the workflow as soon as possible.

  7. Qualification And Validation Of Isolator Systems
    6/26/2018

    Successful qualification and documentation processes start in the planning phase of a project, follow through manufacturing and lifecycle of the equipment.

  8. A Guide to Decreasing Contaminants In Sterile Manufacturing
    6/20/2018

    Containment is key during aseptic processing and this has led to the development of new transfer methods that are both enclosed and minimize the requirement for operator intervention.

  9. Digital Color Inspection Optimizes Color Management In Packaging
    6/5/2018

    Color is one of, if not the most critical component of a brand’s image, but it is also one of the most finicky and subjective components companies need to agree on.

  10. Manufacturing Of Sterile Aqueous Suspensions: A Primer
    5/14/2018

    Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing.