Bristol Myers Squibb (BMS) established its first European cell therapy manufacturing facility at Leiden Bio Science Park in 2021, marking the company's fifth cell therapy production site worldwide. The facility became fully operational in 2024. Senior Manufacturing Associate Buse Mutaf Gülüm, who has worked at BMS for more than three years, looks back on the start-up phase and explains why single-use technology is indispensable for CAR T-cell manufacturing.
Gülüm is enthusiastic about both her work at BMS and the vibrant atmosphere at Leiden Bio Science Park. "The LBSP is full of opportunities, the university is nearby, and there are so many innovative biotechnology companies around us. It's a very inspiring environment to work in."
Originally from Türkiye, Gülüm studied Genetics and Bioengineering at Istanbul Bilgi University. After working for two years at a Turkish biopharmaceutical company, she decided to broaden her horizons and look for opportunities abroad. She moved to the Netherlands to join HALIX, where she worked on the production of a COVID-19 vaccine. In 2023, she joined Bristol Myers Squibb in Leiden.
CAR T-cell therapy
At the Leiden facility, BMS manufactures personalized CAR T-cell therapies. CAR T-cell therapy is an advanced form of immunotherapy in which a patient's own T cells are genetically modified to recognize and destroy cancer cells.
"It starts with collecting a patient's T cells at the hospital," Gülüm explains. "The cells are transported to Leiden, where they are genetically engineered and expanded in our GMP facility. They are then shipped back to the treating hospital for infusion into the patient. Previously, European patient cells had to be sent to the United States for processing before being returned to Europe. Manufacturing therapies closer to patients has the potential to reduce transportation time and support shorter vein-to-vein times.”
The Leiden site currently manufactures two CAR T-cell therapies: Breyanzi® (lisocabtagene maraleucel), for several types of B-cell lymphoma, and Abecma® (idecabtagene vicleucel), for the treatment of multiple myeloma. The facility manufactures CAR T-cell therapies for European patients since March 2026.
Challenge
As a Senior Manufacturing Associate, Gülüm works directly in production while also being responsible for patient and operator safety and quality. "My job is to ensure that every CAR T product is safe for infusion into the patient and that my colleagues can work safely with human blood, cells and viral vectors."
She was closely involved in commissioning the new facility and carrying out the qualification and test runs before commercial manufacturing began.
"Starting a completely new CAR T manufacturing facility in Leiden was certainly a challenge," she says. "Fortunately, we could build on the experience of our existing facilities in the United States, so we didn't have to start from scratch. At the same time, there were differences to deal with, such as local regulations and the availability of materials and equipment. Our goal was to replicate the US manufacturing process as closely as possible, but sometimes identical components simply weren't available. In those cases, we had to identify suitable alternatives."
Single-use technology
Throughout most of her career, Gülüm has worked with single-use technologies. She has seen the technology mature considerably over the years.
"In the early days, equipment from different suppliers wasn't always compatible. If you bought single-use systems from one supplier, you were often tied to that supplier because connecting products from different manufacturers could be difficult. Today interoperability has improved significantly, at least among the major suppliers. "
“Single-use technology has become essential for advanced cell therapy manufacturing”, she continues. "It provides the flexibility, sterility and efficiency that these highly personalized therapies require. But the future of biopharmaceutical manufacturing depends on more than technology alone. It also depends on the people who operate it. Technology can only achieve its full potential when skilled, dedicated people work together to make these life-changing therapies available to patients."
Bron: Single-use.nu