White Papers

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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. 

  7. ISPE SMEPAC Guidelines Driving High Potency Facilities And Equipment
    5/10/2018

    Working towards a goal to define current good practices providing information to allow organizations to benchmark their practices and improve on them.

  8. Choosing The Best Sterile Dosage Form For Your Phase I Clinical Supply Needs
    5/2/2018

    When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.

  9. In-House Versus Outsource: A Decision-Making Guide
    5/2/2018

    Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.

  10. High-Volume Manufacturing: Essential Points To Consider Before You Scale Up
    4/20/2018

    To successfully scale to high-volume manufacturing, planning is required for streamlining the production process and minimizing the changes that could add unnecessary time and expense to the process.