Featured Bioprocessing Editorial

  1. 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.

  2. 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.

  3. Champions Against Nonsense: A Better Way To Talk (And Think) About Quality
    1/30/2019

    This is the second of three articles focusing on an effort to address what appear to be systemic issues across quality departments. This article addresses how to reframe the way we view and discuss quality, how to better engage stakeholders, and an alternate view of how quality can add value to the company.

  4. How Healthy Is The Biopharma Pipeline Heading Into 2019?
    1/28/2019

    This article analyzes key indicators of pipeline strength over the past three years, including R&D spend, new chemical entity approvals, and Phase 2 and Phase 3 development. 

  5. CAR T-Cell Therapies In The EU5: What Can We Expect From Payers?
    1/24/2019

    The difficulty of balancing paying for innovation with budgets has plagued Europe for years, and the emergence of cell and gene therapies has only exacerbated that conundrum. 

  6. Reimagining Aseptic Processing: What Must Change?
    1/21/2019

    This is the second in a three-part series exploring the need to achieve improvement in aseptic processing of sterile biopharma products. Part 1 presented the current state and opportunity for improvement using innovative technology. Part 2 discusses changes in strategy that might be needed as a result of technology implementations. 

  7. Cleaning Process Development: Cleanability Testing And “Hardest-To-Clean” Pharmaceutical Products
    1/18/2019

    Cleanability is clearly an important parameter for determining the hardest-to-clean product for use in cleaning validation studies, and reliable methods for this determination are needed. For any analysis, quantitative methods should be preferred over qualitative methods as they are scientific, not subjective, and allow the easy application of statistical evaluation.

  8. ICH Q12: Bringing Regulatory Flexibility To Post-Approval Changes
    1/16/2019

    The convergence of regulatory agencies and acceptance of ICH Q12 across multiple agencies opens up opportunities for changes with minimal supply chain disruptions.

  9. Are You The Weak Link In Your Own Pharma/Biotech Supply Chain? How To Find Out — And Fix It
    1/14/2019

    A team composed of nearly 70 FDA, pharma/biotech, and medical device leaders — spanning 39 organizations and five countries — have concluded that companies trying to get a handle on issues in their supply chains should focus less on their suppliers and more on themselves as the possible source of the problems.

  10. FDA Shutdown: Assessing The Potential Impact On Innovation And Public Health
    1/11/2019

    I am not an expert on immigration or building walls. I don’t pretend that I can totally understand the political strategy of either party at the high level of the government shutdown. But as someone very familiar with the FDA, I am growing increasingly concerned that the longer the government shutdown continues — dragging the FDA along with it — the greater the potential for harm to the public health.