BIOPROCESS OUTSOURCING FEATURED ARTICLES

FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products

At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

• A New Cost Paradigm For CAR Cell Therapies?
• ILC Therapeutics' Interferon Alpha 14 Joins The COVID-19 Fight

• New Podcast: Building Blocks Of The Biopharma Business

  We just launched the first full episode of the Business of Biotech podcast, a series purpose-built for the leaders of new and emerging biopharma companies. Here’s a recap of the first episode with industry icon Allan Shaw, highlighting the season to come and offering some strategic, straightforward advice for new biopharma leaders.

• DARPA's Challenge: Manufacture A Biopharmaceutical In Less Than 24 Hours

  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.

• ISPE Set To Address Drug Shortages At Annual Meeting

  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.”