Featured Bioprocessing Editorial

  1. 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. 

  2. 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. 

  3. 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. 

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Who Will Win The Regenerative Medicine For Diabetes Race?
    1/10/2019

    Regenerative medicine could be a game-changing approach to meet the needs of insulin-dependent patients. Although the field is still in its infancy, the initial clinical data looks promising. This article takes a closer look at a few innovative companies that are racing to bring the first regenerative medicine for diabetes to the market.

  9. “What, You Call That A RABS?” Seven (Real-Life) Aseptic Filling Blunders
    1/9/2019

    This article is based upon the authors' travels over the last 10 years, looking at aseptic filling operations and seeing what was described to be “a RABS” by the various owners. Some of these are actually amusing, and they illustrate what happens when “hands-on” engineering meets the needs of operations while the compliance department is asleep at the wheel.

  10. How To Establish Growth Promotion Tests For Pharmaceutical Culture Media
    1/7/2019

    The article discusses some of the guidance documents and regulatory expectations regarding media growth promotion and provides guidance on establishing a compliant growth promotion test.