There have been considerable updates in the Brexit situation since April 2017, including, the surprising result of the U.K. general election. If anything, news regarding Brexit and the biopharma industry has started to heat up in recent months, and there have been a number of relevant developments that manufacturers must keep their eye on.
This article presents a totality of evidence approach to show superior sterility performance of a well-designed closed system compared to conventional aseptic processing, and to design the control strategy.
It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.
In the ongoing battle to cut costs while delivering quality and technically sound product, the biotech industry has spent the past two decades gradually moving toward single-use pre-sterilized plastic equipment for both clinical batch and, where applicable, production scale manufacturing. Single-use process equipment can be used and then disposed of, eliminating the development time to validate the sterilization and in-facility sterilization downtime, as well as development time to qualify and verify the cleaning and commensurate cleaning downtime.
Inadequate communication between the consultant and the client, especially at the initial engagement phase, is often not taken seriously enough or addressed sufficiently on both sides.
We need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking.
How can we reduce these risks and increase the success in adopting new technologies and better supply chains? Part of the answer is better collaboration between industry, academia, and government.