Clinical and Commercial Manufacturing for Oral Solid Dose in Greenville, North Carolina
Learn why this supply chain executive calls Thermo Fisher Scientific the CDMO partner of choice.
Learn how a global CDMO never loses sight of what’s important to our clients.
Learn how Amylyx Pharmaceuticals partners with Thermo Fisher Scientific to bring hope to patients with ALS.
Learn how Reneo Pharma was able to get to clinic in 14 weeks from delivery of their API.
Discover Thermo Fisher Scientific’s formulation and clinical manufacturing site in Milton Park, UK featuring proven expertise in early development and oral solid dose.
Our Brisbane, Australia site is 2014 winner of the ISPE Facility of the Year award and 2015 winner of the Frost and Sullivan APAC CMO of the year award. The site provides scale up and manufacturing services of recombinant proteins and monoclonal antibodies.
As members of the United States Air Force, Lauryn and Chris were as healthy and fit as a young couple could be. But in the world of genetics, all it takes is a couple of proteins lining up in the wrong way, and things can change in a hurry. They found that out when two of their three children tested positive for Cystic Fibrosis (CF). Lauryn and Chris were both carriers of mutations that, when combined, caused the disease. So an active life was replaced with one of endless treatments, trips to the doctor and fear of catching even the slightest cold. Plus the knowledge that life expectancy for patients with CF was typically about 31. Something no parent wants to hear. They learned of a “wonder drug” helping CF patients – one that actually treated the underlying causes of the disease, not just the symptoms. Best of all, it was manufactured in their backyard in Reading, Ohio. After about 6 months of taking the medicine, their doctor said something they hadn’t heard before: “Your daughter looks healthy.” And best of all, life expectancy for patients who respond to this therapy is now into the 60s and beyond. So these two veterans can now look forward to all the dreams that parents have for their kids, including a long life and children of their own some day.
Several Chinese pharmaceutical companies were competing to be first to market. And second place didn’t matter. Hui Wang, from Thermo Fisher’s Brisbane, Australia site, had a client trying to become the first Chinese pharmaceutical company to bring a cancer drug to the U.S. market. The complication? They’re a Chinese company who has never done business in the west. Clearly translators would have to keep things moving. But speaking both Mandarin and English wasn’t enough. With speed at a premium and a tech transfer document needed asap, Hui also needed to be fluent in the language of science. With her extensive scientific and manufacturing background, she worked with client teams, translating technical information in real time. So the process never slowed down. In fact, instead of taking the typical two months, the initial tech transfer document was ready in two weeks. Allowing her client to win that race.
A Korean client was wary of working with a global manufacturing and outsourcing partner because of perceived complications. Different departments, divisions and regions would surely create multiple teams, workflows and contracts to sort through. They believed it would be better to handle as many of the steps themselves as they possibly could. But Yoonhee knew the power of collaboration across Thermo Fisher’s Patheon and Fisher Clinical Services businesses would ensure success. While tirelessly working to ensure a seamless experience for her client, Yoonhee brought together multiple project managers into one team. From there, they coordinated the end-to-end process, from IP manufacturing through supply chain. The client saved months in the process. And now, Thermo Fisher offers one integrated program team under one umbrella CDA and MSA to save clients time and energy right from the start.
When Hurricane Maria hit the island of Puerto Rico as a Category 4 storm, it decimated everything. The entire island was knocked off the grid. No power. No fuel. No water. No food. No communications. Roads were blocked and people everywhere struggled in an environment of complete turmoil. As the General Manager of Thermo Fisher’s drug manufacturing site in Manati, Puerto Rico, Francis had a seemingly insurmountable challenge ahead of him. But with his calm demeanor, he took it one step at a time. First priority, find his people. Make sure they and their families are safe. Next, get to the site, begin the process of bringing it back. Then, establish communications by setting up a network of information distribution until cell service could return (weeks later). Give the growing list of employees managing to show up for work, despite all that was going on in their lives, more and more jobs to get the facility operational again. Keep clients informed of daily developments and goals. And most important, get the equipment up and running so that patients around the world didn’t go without their life-saving medications. Francis even opened the facility to locally-based clients on the island who needed a place to work. And finally, with the full efforts of his whole team, the facility was back online two months after the storm. It just goes to show how far you can go with commitment, teamwork and a ton of heart.
In the world of drug manufacturing not all life-saving decisions happen in the lab. Sometimes it’s a lot closer to delivery that key moments require fast thinking. Such as one Saturday morning in Memphis, TN, when Marcus noticed the freezer temperatures were out of range. With over 2,000 cold chain shipments leaving his facility per day, he couldn’t afford to lose a week’s supply due to warm temperatures. As the repair crew worked on the issue, Marcus knew it wasn’t an easy fix and he needed a backup. So he had to make a call, on a weekend, without time to consult the chain of command. Soon, Marcus had a few freezer trailers on site, and an emergency work crew helping to load ice into them, so they could keep the week’s supply safe. And on Sunday, when he got the notification that the main freezer was having issues again, he knew he had made the right call. Today, the freezer is fully operational, and such issues are rare. However, we now keep extra freezer trailers on site permanently as a back-up, just in case.
It all starts with your discovery. A molecule, small or large, that needs a partner. Let Patheon be that partner.
Discover Thermo Fisher Scientific’s early development site in Bend, Oregon, featuring proven expertise in solving solubility challenges for clients.
Learn about Thermo Fisher Scientific’s expansion of its biologics site in St. Louis, Missouri. The facility will be the single largest single-use technology CDMO in the United States.
Meet the people who work with our clients at our API development and manufacturing site in Florence, South Carolina. Florence East is Patheon’s new, state-of-the-art API manufacturing facility that works on molecules from preclinical through commercialization. The team at Florence East works with batches of all sizes, from 10 kg demo runs in the pilot plant to metric tons in the commercialization facility – all at the same site.
Take a look inside Thermo Fisher Scientific’s sterile fill-finish manufacturing site in Monza, Italy. The site currently manufactures commercial supply, but has recently invested $50 million in sterile drug development capabilities.
Collaboration is an important part of our culture at Thermo Fisher Scientific and it starts with our people. Emily and Jessica are a great example of how a mentor relationship facilitates the transfer of critical knowledge to achieve long-term results. This information sharing allows us to get product into the hands of our clients faster, resulting in patients receiving their medications sooner.
At Thermo Fisher Scientific, everything we do is made with the right balance of heart and science. Find out how Angie and our Fisher Clinical Services team went above and beyond to overcome tough obstacles in order to ensure thousands of patients around the globe received life-saving medications.
Learn how Whitney took on the challenge of creating more flexibility within existing rigid processes to better meet the needs of her client. Together, they came up with a solution to optimize critical paths forward to expedite getting life-saving therapies to the patients who need them.
The stakes were high for a client who needed material for a novel drug to in order to proceed to clinical trial. With millions of dollars on the line, Jeff’s team had one shot to develop a process to scale up or risk failing the batch. They took critical steps forward to de-risk the process and solve the problem. Helping our clients hit their next milestone is why we go to work every day.
Tony and the team at Thermo Fisher Scientific understand the needs of small and emerging companies. They come to us to take advantage of our experience, expertise and global network. When every dollar counts and everything is on the line, companies put their trust in our experts to provide a solution. Tony’s “eureka moment” helped this small company make a big impact.
Meet Gavin and his mom, Nicole. Learn how Gavin’s battle with a brain tumor led him to the bottle of hope that allowed him to be a kid again. His courage and refusal to give up proved that not even a brain tumor can hold him back from his big plans for the future.
The combination of Fisher Clinical services with Patheon manufacturing brings an entirely new level of customer service to the pharmaceutical industry. Watch this video to see the clinical supply chain in action, between Patheon in Monza, Italy and Fisher Clinical in Basel, Switzerland.
We are the first CDMO to build and manufacturing client product on a continuous manufacturing line. The suite, located at the site in Greenville, NC, is custom built to utilize the best equipment available. The cutting-edge process allows materials to flow through several small-unit operations without stopping. The result? Lower costs, reduced interbatch variability, and tighter process control.
From preclinical to clinical trial distribution to commercial manufacturing, we can help you through the entire process.
Kaspar van den Dries, Ph.D. discusses the benefits of working with Patheon for your softgels project.
Learn more about the Softgel expertise at Patheon, by Thermo Fisher Scientific.
Kaspar van den Dries, Ph.D. discusses the many advantages for drug developers who choose Softgels.
Tony van Bijleveld, Head of Softgels Business Unit discusses the benefits of the recent Thermo Fisher Scientific acquisition, as well as Softgel expertise & technology to enable innovative customer solutions for patients.
Learn more about the capabilities and expertise at our Swindon, UK site.
Patheon’s Jennifer Therrien discusses findings of a Tufts Center for the Study of Drug Development (CSDD) study that reveals how pharmaceutical companies using a single-source outsourcing partner can achieve a net gain of $45 million in early drug development.
Michel Lagarde, President of Pharma Services, Thermo Fisher Scientific, discusses why Pharma Services employees are so passionate about partnering with small and emerging biopharma clients.
Leon Wyszkowski, President of the Clinical Trials Division of Thermo Fisher Scientific, discusses the value of Patheon and Fisher Clinical Services joining together to provide integrated solutions for our clients.
Video Webinar with The Medicine Maker, Chapter 1: Understanding Industry Shifts
Video Webinar with The Medicine Maker, Chapter 2: Overcoming Commercial Launch Challenges
Video Webinar with The Medicine Maker, Chapter 3: Identifying Volatile Forecast Variables
Video Webinar with The Medicine Maker, Chapter 4: Measuring Forecast Accuracy
Video Webinar with The Medicine Maker, Chapter 5: Planning for Insourcing or Outsourcing
Video Webinar with The Medicine Maker, Chapter 6: Leading Industry Transformation