Quality by Design Featured Articles

  1. Solving the OOS Problem with Continuous Manufacturing
    8/13/2017

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec. And when it isn’t, as will sometimes (albeit rarely) happen, the manufacturer can step in more quickly than ever before to limit the volume of OOS product — saving time, money, and staying ever closer to the ideal quality standard.

  2. Viral Safety Approaches For Advanced Therapy Medicinal Products
    7/11/2017

    Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”

  3. Critical Opportunity For Pharmaceutical And Process Understanding
    4/28/2017

    Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving pharma to improve product and process quality and efficiency.

  4. Porosity And Its Influence On Pharmaceutical Tablet Dissolution Profiles
    4/21/2017

    Drug delivery as solid dosage forms is complex with a number of factors that can noticeably influence their therapeutic benefit. 

  5. Materials Characterization In Pharma
    4/20/2017

    Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.

  6. Physical Properties Tests For The Pharmaceutical Engineer
    2/23/2017

    Products packaged for consumer use by the pharma industry go through a battery of tests related to how the user applies the product. 

  7. 3 Development Principles Of Advanced Biopharmaceutical Tubing
    10/14/2016

    Every component used in biopharmaceutical processing — large or small — is pivotal to the ultimate goal of delivering safe and effective medication. Advancements associated with tubing may not necessarily be perceived as revolutionary, but there is an ability to innovate in this space. To deliver cleaner materials and actively mitigate risk in biopharmaceutical manufacturing, evaluation of single-use tubing based on the three development principles in this article should take place.

  8. An Introduction To Biopharmaceutical Facility Design & Layout
    6/23/2016

    This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.

  9. The Impact Of Waste On The Cost Of Quality In The Pharma Industry
    6/22/2016

    Waste has a significant impact on the cost of quality (COQ) — or more exactly, the cost of poor quality — in the pharmaceutical industry.

  10. Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off
    5/20/2016

    Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.