Featured Bioprocessing Editorial

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

    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.

  2. FDA Shutdown: Assessing The Potential Impact On Innovation And Public Health

    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.

  3. Who Will Win The Regenerative Medicine For Diabetes Race?

    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.

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

    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.

  5. How To Establish Growth Promotion Tests For Pharmaceutical Culture Media

    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.

  6. Strategies For Implementing An Improved Change Management Process

    In the first article of this two-part series, we provided an overview of a co-creation model for change management and the tools and methodologies that form the foundation for improved change management. This second part will look at strategies for implementing an improved change management process.

  7. FDA’s New Data Integrity Guidance — Highlights & Observations

    The FDA recently posted the final guidance Data Integrity and Compliance with Drug CGMP Questions and Answers, finalizing a draft first published in April 2016. This article provides an overview and analysis of the guidance's 18 questions, which span the broad areas of data integrity and data governance.

  8. mAbs For Migraines: Crowded Field A Headache For Drug Developers

    With the U.S. launch of three anti-CGRP (calcitonin gene-related peptide) monoclonal antibodies likely on the way soon — many questions remain about how physicians will choose between these new migraine-prevention drugs and which among them may ultimately win out.

  9. Why Now Is The Time For An Aseptic Processing Revolution

    This article is the first in a three-part series exploring the need and means to achieve improvement in aseptic processing of sterile biopharmaceutical products. Part 1 presents the current state and opportunity for improvement using innovative technology. Part 2 further discusses some of the changes in strategy that might be needed for and result from the use and improvement of technology. Part 3 presents the impact of technology changes.

  10. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019

    Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.