Janssen’s CM line in Peurto Rico is the result of a ten-year long collaboration between the company and Rutgers University. After seeking regulatory approval, the company will be allowed to manufacture commercially – and they are already working on the next product to be put on the line.
“Traditional batch process operations are done one by one,” explains Mauricio Futran, VP of Process Science and Advanced Analytics at Johnson & Johnson. “The problem with that is if something doesn’t come out okay it’s too late; there’s nothing you can do. You can’t go back and undo what you did in the beginning.”
According to Futran, the beauty of CM is its use of modern technology that allows for continuous monitoring of the tablets and intermediate materials’ properties in real-time.
“If anything starts drifting from what we want it to be we can respond in real-time to keep the process in the parameters where they need to be,” he explains.
This helps assure high quality, but with a lot less waste and in a much more efficient manner.
“With real-time information it is much more useful to react instead of checking everything at the end.”
Measuring up
A big part of the job is demonstrating changes in manufacturing don’t change a medication’s performance. This begins at the beginning of the line with the machine’s feeders.
“We start by characterizing how components behave,” explains Futran. “How do they respond to changes in speed? How long does it stay at each operation?”
Answering these questions allows them to program the feeders to give the right formula.
“Understanding the behavior of the material in that respect is important,” adds Futran.
However, because they can to do real-time measurements, they are able to develop specific measurements for each material.
“A lot of science goes into the sensors used to get concentrations and proportion readings. Those things you normally don’t do in a batch situation.”
According to Futran, the greatest challenge in adopting CM has been using these new measuring sensors and equipment that have not traditionally been used.
“It’s different when you measure something on a lab bench when everything is quiet, than when it’s flowing past a window,” he explains. “Things behave a little different and it can be more challenging.”
However, Futron views the experience as a chance to develop a deeper understanding of the process and to gain greater control over what they do.
Future plans
The company’s goal is to convert much of their exiting high volume medications into this technology one by one. “We see a lot of advantages,” says Futran. Although, every medicine has different parameters, and not all of them will be suitable for CM.
Janssen predicts that 70% of its products, by volume, will be manufactured this way in this way in the future. Additionally, according to Futran, new products will most likely be developed in this manner from the beginning.
“CMOs and CROs are also supporting this type of activity,” says Futran, which is a good indication that there is broad support for the technique.