ARTICLES BY TRISHA GLADD
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.
Is Your Supply Chain Ready For the Biopharma Tidal Wave?
In order to manage risk in your supply chain, you have to know where it exists. The same logic is applied when quantifying risks during a process change. Just as a lack of quality affects the patient, so does a lack of supply. So what can you do to ensure your supply chain provides a safe and efficient delivery of your product?
Academia Is Pivotal To The Future Of Pharma Innovation
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.
Genzyme Pioneering Continuous Manufacturing In Biotech
One company that has made significant progress in the development of a continuous manufacturing platform for large molecule drugs is Genzyme. I recently spoke with Jason Walther, a staff scientist at Genzyme, about the impact of continuous manufacturing on the industry as well as its potential.
Drug Shortages Highlight Quality Problems
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.
Standardized Extractables Testing Advances Single Use Adoption
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.
Quality Risk Management: Reduce Risk By Embracing It
Despite the resources available to help companies develop a QRM program, such as the ICH Q9, there are several challenges that commonly prevent a successful implementation. Ghada Haddad, director in global sterile and validation at Merck, suggests several best practices that can help overcome these issues.
Quality Takes Center Stage At ISPE Event
As the pharmaceutical landscape continues to change and evolve, it is up to you to not only determine how to raise the bar for innovation but also do so with the utmost focus on quality. If you take a look at the ISPE/FDA/PQRI Quality Manufacturing Conference agenda, attendees will see this is an opportunity to learn how to accomplish just that.
Top Single-Use Suppliers Make Standardized Equipment A Reality – Part 2
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.
Top Single-Use Suppliers Make Standardized Equipment A Reality – Part 1
While standardization of single-use equipment for end users would mean a plug-and-play approach that would facilitate the implementation of single-use in their facilities, some believe there are suppliers who do not want to move forward with it because they are fearful they will reduce or eliminate their ability to differentiate themselves and remain competitive. However, the argument may be a moot point soon.