This is the seventh post in our Lilly Discovery series that describes how Lilly employees discover and develop innovative treatments for patients. We're also highlighting many of the passionate scientists and clinicians behind Lilly’s cutting-edge discoveries.
As a kid, you may remember the implicit race to finish eating your ice cream cone before the heat of the summer sun beat you to it. Now imagine being tasked with getting a medicine to patients that would “melt” if it were not delivered within an extremely short window of time, usually mere hours.
For John Lister-James, Ph.D., senior vice president, chemical development and manufacturing, Avid Radiopharmaceuticals, a wholly owned subsidiary of Lilly, melting ice cream serves as a metaphor to the manufacturing and shipping of positron emission tomography (PET) radiopharmaceuticals, a challenging process where every minute counts.
What is a PET radiopharmaceutical?
A positron emission tomography (PET) scan is an imaging test that helps reveal certain diseases inside the body. A PET scan uses a radioactive drug (tracer) and a scanner similar to those used to obtain CT scans
“The most important thing when it comes to PET radiopharmaceutical drug supply is time,” says Lister-James, who first encountered nuclear medicine during his post-doctoral work at Massachusetts Institute of Technology (MIT) and Harvard Medical School. “It’s critical to get the medicine to hospitals and patients as quickly as possible. Our teams at Avid and Lilly are driven by knowing that for each batch – made every day – every minute counts when it comes to getting these medicines to patients.”
For Dan von Dielingen, director of manufacturing at Lilly, the seamless partnership between the Lilly and Avid manufacturing teams stems from constant communication and adherence to a set of principles that ensures the reliable supply of medicine with safety first and quality always. “With PET radiopharmaceuticals, the medicine is manufactured, tested, released, transported and administered to the patient all in the same day,” says von Dielingen, a chemical engineer who has worked in manufacturing and quality his entire career.
With a natural penchant for challenges, the Lilly and Avid manufacturing teams face a particular type of challenge when it comes to manufacturing PET radiopharmaceuticals—one that repeats itself every day and impacts patients on a global scale.
“PET radiopharmaceuticals, compared to other drugs, have very short half-lives and, thus, need to be manufactured quite differently,” says Lister-James. “One of the products our teams manufacture has a half-life of about two hours, meaning every two hours, half of its radioactivity disappears; its shelf life is only 10 hours.”
So with the demands of daily manufacturing and no overnight inventory, how do the teams ensure the timely and reliable delivery of medicines? It’s all about infrastructure.
A total of 53 external contract manufacturing facilities are operating across the globe, with 35 of those facilities manufacturing commercial product in the United States and Europe. Both Avid and Lilly work in concert with our external manufacturing partners to ensure the manufacturing process at each specific site meets Lilly’s manufacturing and quality standards and is capable of supporting the unique challenges present with PET radiopharmaceuticals.
“To see firsthand how the medicine you produce makes a difference in people’s lives around the world is a pretty cool thing,” says von Dielingen. “Knowing the impact of that makes it easy to get up every day.”
See how Lilly Manufacturing & Quality continues to strive for excellence in process, standards and behaviors.