Editors' Desk

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Academia Is Pivotal To The Future Of Pharma Innovation 6/17/2015

    We all know that biosimilars have been driving several recent M&As (e.g., Hospira) across the industry. And yes, biosimilars, generics, and second-generation drugs all can keep pipelines and pockets full. But you know what they don’t do — offer new treatments or cures for diseases. That requires innovative R&D and drug development, and that’s why I believe academia is even more important to the industry than ever before.

  6. An All-Outsourcing Model For Orphan Drugs 6/15/2015

    Nils U. Olsson, VP of Chemistry, Manufacturing and Controls at Retrophin Inc., says his company’s business model targeting new drugs for orphan diseases allows for a perfect application of an all-outsourcing strategy. 

  7. What's Really To Blame For Drug Shortages? 6/15/2015

    Prescription drug shortages continue to plague the industry and endanger patients. Most experts suggest quality and manufacturing issues are the cause, but are other (more troubling) market dynamics at play?

  8. Drug Shortages Highlight Quality Problems 6/5/2015

    On the same day the Wall Street Journal published an article highlighting the issue of drug shortages in the US, CDER Director, Dr Janet Woodcock, delivered a keynote at the ISPE Quality Manufacturing Conference. Dr. Woodcock discussed initiatives by the FDA to overcome issues with manufacturing quality, a leading reason for drug shortages in the US. 

  9. 3D Printing Poised To Make Big Pharma Impact 6/3/2015

    While 3D printing is making a huge impact in other areas of healthcare, it has yet to make a splash in the pharmaceutical industry. However, a recent study reveals how 3D printing can help enhance the customization and personalization of medicines in the near future.

  10. Standardized Extractables Testing Advances Single Use Adoption 6/3/2015

    The Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing written by BPOG members last year establishes a foundation from which to create a standardized approach to extractables testing. However, since its release, there have been some questions and discussions about how to effectively implement the protocol.