Featured Bioprocessing Editorial

  1. Why Data Integrity Is Impossible Without A Quality Culture
    2/19/2019

    For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”

  2. Reimagining Quality Operations In The Life Sciences
    2/13/2019

    This article examines how to achieve cross-functional ownership of quality and the efforts of the CQO team to build quality for the 21st century, including exploring the creation of formal degree programs in quality.

  3. How Technology Will Reshape The Future Of Aseptic Processing
    2/11/2019

    Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring. 

  4. For Whom Is Bioprocessing Capacity Scarce?
    2/6/2019

    ISR data, collected for the purpose of improving our understanding of the much-anticipated bioprocessing capacity crunch, reveals that it is not a matter of if or when a capacity crunch will impact the biopharmaceutical industry; instead, it’s a question of who, or which types of drug innovators, will be impacted.

  5. How To Write An Effective Validation Master Plan
    2/6/2019

    A validation master plan outlines the principles involved in the qualification of a facility, defining the areas to be validated, and provides a written program for achieving and maintaining a qualified facility.

  6. Overcoming The Unique Filling Challenges Of Autologous Therapies
    2/5/2019

    Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.

  7. What Is Skinny Labeling — And Will It Work For Biosimilars?
    2/5/2019

    “Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.

  8. The Top 3 Forms Of Operational Overcomplexity In Pharma Manufacturing — And How To Simplify Them
    2/4/2019

    We like simplicity. Yet in pharmaceutical operations we have become very good at making things more complex than they need to be.  This article illustrates a few areas where companies tend to make matters worse and highlights areas where both industry and regulatory agency leaders should push back and focus on simplification.

  9. An Analysis Of FDA FY2018 Drug GMP Warning Letters
    2/1/2019

    This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms.

  10. 6 Ways AI Is Transforming The Life Sciences (Already)
    1/31/2019

    Most in the life sciences agree that artificial intelligence (AI) will reshape the sector from R&D through commercial. Although AI has only just left the starting gate, and most activity is in exploratory phases, some benefits are starting to emerge. And there are pockets of early adopters trailblazing new approaches and seeking a competitive edge.