From the Editor May 2016

S. Anne Montgomery

May 11, 2016

3 Min Read

SAM-thoughtful-240x300.jpgEvery now and then in the biopharmaceutical industry, a technology or concept seems to take hold and suddenly appears everywhere — in print, at conferences, in workshops and online media offerings, and as part of new product launches. This happened in the 1990s when process validation was (seemingly suddenly) the theme of the day, and it happened briefly later that decade when transgenics appeared to be a potential game changer.

Single-use technologies of course precipitated arguably the most widespread set of “disruptions” to accepted ways of approaching development and biomanufacturing processes — with worldwide ramifications. About the same time that disposables began to deserve greater coverage, we also began to see more practical details from biomanufacturers implementing the quality by design (QbD) regulatory initiative. And unlike the situation was 10 years ago, the concept of process analytical technologies (PAT) now actually means something to most people working in the modern biotechnology industry.

Enter the next logical extension of all the above: continuous processing. This is far from a new concept in other industries, and it has been championed in biotechnology laboratories and among some biopharmaceutical industry proponents for quite some time. But what continuous processing really means and how it could look in a bioprocess setting has until now been more conceptual than practical.

That seems to have changed, however, if you go by the number of presentations and case studies offered on the topic at our recent BPI West conference in Oakland, CA, and the BPI European Summit in Vienna. Companies of all sizes are now offering real examples of biomanufacturing operations that are working at least in semicontinuous modes. And suppliers are launching scalable families of equipment to support this trend.

So proceeding with the idea that we should take a theme and explore it from as many angles as editorially possible, this issue launches our first special report on the topic, written by freelancer Angelo DePalma. It ends with a short set of comments from GE Healthcare’s Günter Jagschies about his expectations of these technologies. Also in this issue, authors from Sanofi and Sartorius report on their collaboration to install a continuous downstream process — offering a real example of such approaches highlighted in Angelo’s report.

Following those, authors from Pall Corporation are scheduled to sponsor an entire supplement issue in June profiling their own investigations into bioprocesses and enabling technologies for continuous operations. And if you have not read enough about continuous processing by later this year, our November single-use supplement is planned to examine specifically how those technologies are enabling continuous modes of bioprocessing — and what changes might be needed to ensure the robustness of disposable materials for such extended operations.

Far from a desire to inundate you with information, however, is our understanding that BPI readers work at all levels of operations and in many different job functions and company types and sizes. We want to help you put all this information together in a way that helps you succeed in your work — and to plan ahead for what may be coming.SAMfix-sig-300x73.jpg

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