Pharmaceutical Manufacturing Featured Editorial

1. BioMarin Transforms Supplier M&A Into Joint Ventures 4/25/2016

   To navigate supplier and CMO consolidation, Isaac Young, senior director, supply chain operations, BioMarin Pharmaceutical Inc., offers some advice: Approach your outsourcing relationships like joint ventures. “As you have this greater engagement between two companies,” says Young, “you’re likely to enter an interdependent relationship. Why not acknowledge that rather than try to power-play or position one another?”

2. 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.

3. Best Practices For Handling Potent APIs 7/7/2015

   This article addresses the issue of how to overcome the industry challenge of handling highly potent APIs using advanced technologies and techniques that can provide a solution.

4. 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.

5. 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.

6. 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?

7. Facilities Management In BioPharma: Why Is It Important? 6/9/2015

   What is taken for granted until something goes wrong; accounts for the second highest spend (after salaries) by every organization on the planet; is essentially unknown as an industry; is a mystery job function to 99 percent of the working population, and yet, is absolutely critical to the activity and well-being of every single person who works, shops, travels, commutes or lives in public spaces?

8. Top Single-Use Suppliers Make Standardized Equipment A Reality – Part 2 5/8/2015

   Industry experts offer the benefits of standardized single-use equipment to both suppliers and users, as well as how it addresses some of the biggest objections to equipment standardization, as well as offer insight from the eyes of a user.

9. ISPE Set To Address Drug Shortages At Annual Meeting 10/6/2014

   Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.

   The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.

   Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”

10. Investigation Of New Level Technologies In Single Use, Disposable Systems

    This article presents guided wave radar level measurement as an acceptable, less expensive alternate to load cell systems. By David Ladoski and Dan Klees