Bioprocessing White Papers

  1. Purification Of Antibody Fragments And Single Domain Antibodies With Amsphere™ A3 Protein A Resin
    10/12/2017

    The wide range of antibody fragment variants for which Amsphere A3 can be used as a capture resin is described, together with insight to the related binding mechanisms obtained via x-ray crystallography.

  2. How Fit Is Your Biopharmaceutical Manufacturing Facility?
    9/7/2017

    How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.

  3. How To Overcome Validation Challenges In A Single-Use World
    9/7/2017

    How can end users ensure the expected level of compliance in this new world of single-use systems? The secret: shared responsibility for validation with your supply chain.

  4. Insights And Tips When Addressing Bioburden Challenges
    8/30/2017

    This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

  5. Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing
    8/30/2017

    A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

  6. Manufacturing Process Scale-Up For Phase III
    8/15/2017

    The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.

  7. Managing Demand Uncertainty In Biologics Production
    8/9/2017

    How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

  8. Improving Compliance And Manufacturing Efficiency In Life Sciences
    8/7/2017

    Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. Read on to understand strategies, frameworks and recommendations to achieve these goals.

  9. Low Particulate Carboys Can Help Improve Biopharmaceutical Production And Vaccine Production
    8/1/2017

    USP <788> and equivalent regulations require that injectables are at or below particulate limits outlined in the regulation. Particulates can come from the drug ingredients, containers, tubing and equipment used in production of these products. Some products cannot be filtered prior to final fill, requiring a process which limits particulate-contributing factors wherever possible throughout manufacturing. Pre-cleaned, sterile, ready-to-use containers ease this burden.

  10. Leverage The Internet Of Things Within The Laboratory
    8/1/2017

    As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms.