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Immunex Successful
FDA Site Inspection
Excellence is hard to feign, at least for any sustained period of time. Sooner or later, mistakes come to light and businesses must address them. At Immunex's Oral Solid Dose (OSD) facility, excellence is so deeply ingrained in the culture of manufacturing operations that the FDA found not a single problem or “observation” that required a correction during its recent site inspection of the new CureX manufacturing facility.
More than just a simple accolade, this achievement has real-world impact: The OSD site is now poised to receive FDA approval to begin manufacturing CureX, the site’s first-ever small molecule drug to be internally manufactured by Immunex operations.
Fauxgen Patient Services Team Embodies the
True Spirit of Giving
In an era when “customer service” is often just a title for the person who stands behind a counter, Fauxgen employees elevate the phrase to its loftiest purpose.
Known as the Patient Services team, the individuals who interact with patients every day exude warmth, caring and genuine concern for the people who use Fauxgen therapies. They impart knowledge, triage complications, procure products, and serve as a critical link between patients, pharmacies and healthcare providers.
Shut Down, Ramp Up
Ask anyone involved in Xion Pharmaceuticals' manufacturing shutdown, and you’ll quickly learn that “Ramp Up” is a more appropriate term for this 6-week process, in which hundreds of highly skilled workers converge in a massive effort to upgrade, enhance, improve and expand the plant’s capacity.
It is all the more challenging that shutdown is occurring during the site’s busiest year in history, when production needs are at an all-time high.
New World of Possibilities Opens
for Summer Interns
As a newly minted high school graduate, Zavier Eure felt lucky to have scored a paid summer internship at a thriving company in Durham. He hoped to absorb as much knowledge as he could between the courier runs and coffee refills that typically fall on summer interns.
Five weeks later, Eure has yet to pour a cup of coffee, but he can readily spew facts about the P7 purification suite, its ultrafiltration system, and the gas chromatography skids at Biogen's RTP manufacturing plant. As a temporary member of Biogen's global project engineering team, Eure is tasked with creating a process flow diagram depicting each step in the drug purification process.
Immunex Wins FDA Approval to Begin Manufacture of CureX
Immunex has reason to celebrate. After a perfect site inspection in April, the FDA has formally approved the RTP site as the first facility in the U.S. to manufacture CureX, Immunex's leading drug for patients with diabetes.
Excitement across the site is palpable, as employees and leadership offer praise for the laser-like focus that secured this big win at warp speed.
“We made a commitment two years ago that required a very aggressive and ambitious schedule to bring online a new manufacturing capability, and this team has delivered on it with results that are far better than we could have anticipated,” said Samuel Ferguson, Vice President and General Manager of the RTP site. “You couldn’t have constructed a more perfect technology transfer from large-molecule to small-molecule manufacturing.”
Town Hall Meeting Emphasizes Fast, Simple, Entrepreneurial Culture
Xion Pharmaceuticals' past, present and future converged last week in a sunlit room filled to capacity with employees eager to hear from leadership about how they can top 2014’s unparalleled success with another year of record-breaking production.
“If it seemed like one of the busiest years in our site’s history, that’s because it was,” said Robert Martinez, Director of Operations for the manufacturing site. “Seventeen campaigns and 5 PVRs: there aren’t many biological sites that can make that claim. We should all be proud of what we’ve accomplished.”