ARTICLES BY TRISHA GLADD
Are Your Single-Use Sensor Tests Set Up To Fail?
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.
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.
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.
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.
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.
Genentech Offers Insight To Increase CMC Development Efficiency
To streamline CMC development each case will have different risks and constraints leading to product-specific CMC approaches, there are general opportunities where pharmaceutical development companies can streamline development and reduce these effects.
What Is the Industry Underestimating About An ADC Supply Chain? – Part 2
In this article, Dan Bell, vice president of regulatory compliance and technical affairs for Marken, discusses regulatory challenges, and both he and Nathan Ihle, Ph.D., VP of CMC Strategy and Management at Seattle Genetics, offer best practices to apply when planning your ADC supply chain.