As the evolution of the global pharmaceutical industry continues to drive the need for more flexibility and lower costs, continuous manufacturing becomes an even more appealing and sensible option. However, despite the tremendous promise of its economic and quality control benefits, there are still many concerns about the regulatory landscape for continuous manufacturing. Dr. Christine Moore, executive director and global head of chemistry, manufacturing and control (CMC) policy at Merck, recently discussed the company’s pursuit of worldwide approval of continuous manufacturing for solid oral dosage products and what regulatory risks it sees as potential roadblocks.
In a survey conducted by Pharma IQ for 2015, which captured the industry’s view on SUT and what challenges it faces, over 100 users were asked about their relationship with their SUT supplier. Of the most important factors identified when choosing a single-use supplier, 64 percent of respondents indicated that the relationship with the supplier ranks as the most important. How important is this as single-use technology adoption increases?
In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.
At this point, it is well known that single-use technology (SUT) can offer many benefits to a manufacturer and their facility. However, there are concerns that single-use technology produces too much harmful waste to achieve sustainability. But is this true?
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.
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.
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.
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.
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.
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.