Issue link: https://www.e-digitaleditions.com/i/648486
competitors for answers. CDMOs are hugely relevant now, and in many cases we are the experts. That's evident in the projects that we participate in. We're not just a pair of hands. We're a partner in their manufacturing development endeavor." Patel agreed that companies rely on CDMO expertise more than ever. It stems, he said, from Big Pharma's focus on two activities: discovery research and commercialization of pharmaceutical products. "The competencies required to do those two things are very different. In fact, they couldn't be further apart in terms of what's critical to being a really strong discovery engine and what's critical to being a really strong commercialization engine." As a result, more companies will turn to outsourcing for help with formulation development, clinical supply, scaleup, manufacturing, and implementing unique tech- nologies, Patel said. "There's an increasing desire for the pharmaceutical companies to tap the best expertise possible in those areas of specialization. It turns out that outsourc- ing—that is partnering and collaborating—is one of the best ways to do that." T&C more power to be specific to our clients needs in each individual case." Process control is key. "The advan- tage comes not in what equipment train we're using, but in how we understand our process and how it's controlled. Then we can make a high-confidence product with fewer deviations." The new line will apply the "S88" approach, a concept used in batch manufacturing and packaging that separates the product's recipe from the process equipment. "The idea is that if you know how to specify what you're doing using the fundamental physics, then you can transfer your product to another piece of equipment, and that Patheon's continuous manufacturing line will use modular components to perform dry granulation, wet granulation, tabletting, and capsule filling. This rendering shows the direct-compression and wet granulation modules positioned below a manifold of six feeders. Patheon plans continuous manufacturing line Patheon plans to continuously manufacture tablets and capsules at its Greenville, NC, site. The project is led by Eric Jayjock, director of continuous manufacturing. "We're pursuing it for many of the same rea- sons that Big Pharma would," he said, but the company isn't following the industry's "natural model" of letting Big Pharma go first. "We see this is a superior approach to manufacturing products. We want to be on the lead- ing edge." Jayjock's experience in the field includes post-doctoral work on a continuous manufacturing collabora- tion between Rutgers University and Janssen. In 2013, he joined Janssen to help implement continuous manufac- turing at its Puerto Rico site. Patheon hired him in 2015. "This is the future, a paradigm shift in technology," Jayjock said. The advantages include higher effi- ciency and the ability to develop products faster while using much less material. Currently, he said, manufac- turing 20- or 50-kilogram batches of clinical trial material requires three to six unit operations and takes a long time. "You have to get the material, run it through the first unit opera- tion, test it, wait for the results, take it to the next one, test it, wait for the results, and so on." That could take several weeks. "In the continuous manufacturing world, we'll turn the line on, and in less than an hour we'll start producing product. We can make enough for a clinical supply in an afternoon." Patheon's line will be built using modular components that interface with each other. "That's the most important overall concept of the line, that we can snap together whatever configuration we need for whatever challenges we have," Jayjock said. There will be modules for feeding, blending, dry granulation, wet granu- lation, compression, and encapsula- tion. A coating module will come later. "We can be super flexible on the new product development level and the tech transfer level and solve process problems by using the equip- ment. That's going to give us all the 14 March 2016 Tablets & Capsules