Editors' Desk

  1. Making The Switch To Single-Use: Have You Thought Of Everything? 8/19/2015

    In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.

  2. Is Sustainability Possible With Single-Use Technology? 8/12/2015

    At this point, it is well known that single-use technology (SUT) can offer many benefits to a manufacturer and their facility. However, there are concerns that single-use technology produces too much harmful waste to achieve sustainability. But is this true?

  3. “Perfect Storm” Demands A Pharma Supply Chain Overhaul 8/10/2015

    According to some pharmaceutical industry experts, a pending explosion in biologics coupled with universally inflexible supply chains are creating a perfect storm that demands and overhaul in order to meet demand. Here’s what you can do today.

  4. New Teva, AstraZeneca Deals To Bolster Emerging Biosimilars Market 7/29/2015

    After this week, it looks like there will be a few big players advancing in the biosimilar market. For those concerned about what a Teva-Mylan acquisition deal would do to the generics industry, recent action on behalf of Teva finally put those fears to bed.

  5. Bringing Legacy Pharma Manufacturing Facilities Into The Modern Age 7/29/2015

    Keeping your pharmaceutical manufacturing facilities up-to-speed with cGMP (current Good Manufacturing Practices) can be challenging, particularly when dealing with legacy facilities. This article provides some best practices on how to modernize legacy sites.

  6. FDA Paves Way For Intelligent Pills 7/17/2015

    The FDA’s approval of various edible sensor and tag technologies now makes it possible to tie digital data to traditional medicines. What does this development mean for pharmaceutical manufacturers?

  7. Are Your Single-Use Sensor Tests Set Up To Fail? 7/9/2015

    When it comes to testing methods, experts warn that the same testing methods used on stainless-steel sensors should not be used for single-use sensors. If an attempt is being made to recreate results achieved with a traditional sensor, it’s very possible for those results to appear unfavorable with a single-use sensor.

  8. DARPA's Challenge: Manufacture A Biopharmaceutical In Less Than 24 Hours 6/26/2015

    In order to ensure American soldiers fighting in remote locations overseas can receive the biopharmaceuticals they need on time, Defense Advanced Research Projects Agency (DARPA) created a program called Biologically-derived Medicines on Demand (Bio-MOD). The goal of Bio-MOD is to build a system that has the ability to create an on-demand biopharmaceutical in less than 24 hours. I spoke with one of the teams working on this effort about how they intend to accomplish this and what it could mean to the future of the industry.

  9. Janssen's Fruitful Continuous Manufacturing Collaboration 6/24/2015

    Janssen Supply Chain’s ongoing partnership with the Rutgers University School of Engineering has produced valuable research and intelligence on continuous manufacturing processes that are enabling the pharma giant to effectively turn the concept into reality.

  10. Why I'd Rather Take A Pill Made By Continuous Manufacturing 6/19/2015

    The pharmaceutical industry finally seems ready to embrace continuous manufacturing. Here’s why this shift will not only be good for business operations, but patients as well.