Uhlmann’s Push for PAT
By Marie Redding
Uhlmann VisioTec began focusing on PAT solutions in 2000, but it became a major initiative in 2004 and 2005. Since then, Christoph Lehmann, director, Uhlmann VisioTec, says this business has been continually increasing. The company provides certain tools that can support many different approaches to PAT. “The more a company does, the more they can save,” says Lehmann.
A project begins with a trial-and-error process to see which solutions will work for a company. “The technology isn’t new. Near-infrared technology was discovered a long time ago. It is a matter of adapting the technology in a unique, customized way, to fit a company’s specific needs and create a custom process. There is no such thing as an off-the-shelf solution in pharma,” says Lehmann.
A trial-and-error method is used to conduct feasibility assessments and determine which approach is best, while all data are measured on paper. Once a need is determined, a sample process is created in the lab. Next, Uhlmann works with companies to create a ‘Proof of Concept’ and decide on a solution.
Customizations are the next step, and then a system is built. “We have three scientists who connect with our clients’ counterparts to understand our customers’ processes, from a scientific perspective. All our ideas must be brought ‘down to earth’ to make a business case. And then we show our customers how much they can save,” explains Lehmann.
One project Uhlmann has worked on was with a company that makes a suspension (a powder in a liquid), in a vial. Filling this vial was tricky, because the concentration was decreasing because of the starting and stopping of the vessel’s pumping mechanism during the filling process and also towards the end of the batch run.
“The insulin suspension was de-mixing due to particle sediment toward the end by unavoidable laws of psychics,” says Lehmann. “They were aware of these issues and decided they needed to stop filling early, with a large safety margin, in order to ensure the proper concentration of each vial.
“The remaining mix in the vessel had to be thrown away, which was very wasteful and not economical,” says Lehmann.
Installing a near-infrared system for inspecting every vial ensured that each had the right concentration. “By having a real-time system in place, every vial is monitored as it is being filled. There is no need to stop filling until you’ve reached your actual threshold,” says Lehmann.
This customer ended up saving a very significant amount in the manufacturing cost of the product, over the course of one year—but Lehmann couldn’t be more specific by sharing the exact number. “Like in this case, it is possible to see a return on investment within an extremely short time—just by adding one monitoring system,” says Lehmann.
Another example of how an NIR system can be useful is when manufacturing transdermal patches. “It can measure the thickness of the coating that contains the embedded drug,” says Lehmann. “Measuring this layer is useful because a big roll run can’t be stopped quickly. And, because the roll is in one piece, you can’t reject just a few patches. Continuous monitoring allows you to see whether the thickness begins to change, so you can fix any issues that begin to arise,” says Lehmann.
An NIR system can also inspect clinical trial packaging, such as a blister, and distinguish between the actives and placebos. “This is a niche application, but it is very important to know that the right drugs have been packaged for use in a clinical trial,” says Lehmann. “This type of system can also tell you the exact composition and dosage of the drug,” he explains.
Continuous manufacturing should be the ultimate goal, for every pharma company, says Lehmann. “We are trying to better understand the complete manufacturing process, looking at it as a whole—without considering packaging separately,” he says. “It is a challenge, to think differently—but pharma is starting to see things from a broader perspective now,” he adds.