Meet the 2022 FOYA Honorable Mention Winner: lovance
Honorable Mention recognizes projects that did not win a specific category but were clearly successful projects that overcame significant challenges in planning, execution, and delivery.
Iovance is a late-stage oncology company that is focused on developing, manufacturing, and commercializing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TILs), treatment. Until now this treatment has proven to be a challenge to deliver to patients in a scalable, timely commercial manner. While traditional facilities work with the aim of producing consistent, repeatable products, the Iovance Cell Therapy Center (iCTC) is designed to produce individual TIL cell therapies for thousands of patients a year. The design of the facility ensures that the quality and integrity of the product is maintained throughout its journey at iCTC. Additionally, Iovance has cut the process time with the goal to become the first facility in the world to produce this type of personalized cancer treatment at a commercial scale.
The iCTC was built with multiple processing rooms, each equipped with the process equipment required to perform any of the operation part of the process. To reduce cross-contamination, each workstation has its own dedicated air handling unit and the overall flow of the facility is unidirectional.
Because each sample is patient-specific, reliability of the facility, of the process utilities, and of the process itself are of the utmost importance. Tor reduce this risk, N+1 redundancies were built into every critical component from the process equipment, storage facility, and power infrastructure to ensure an “always on” state. Since the facility is designed to function 24 hours a day, every day of the year, it was essential that building utilities, systems, and equipment would be able to function in this way and the power system was designed so any single outage would not affect the whole building.
The process of creating a TIL therapy starts in the hospital operating room, where a surgical oncologist removes tumor specimens from the patient. The specimens are then shipped via a specialty medical courier to the iCTC where TILs are isolated and multiplied to generate billions of TILs over a 22-day process. The final product is frozen and shipped back to the hospital. Iovance had to not only successfully design a facility that would develop one-of-a-kind treatments, but also develop a logistical model that would factor in the schedules of surgeons, oncologists, specialty couriers, and airlines. Iovance’s in-house team developed proprietary chain of custody (COC/COI) software that tracks the patient sample from the hospital to the iCTC, the product throughout the iCTC and the final product back to the hospital and patient. They worked with vendors to develop a solution that aims to be best-in-class in providing end-to-end visibility to customers and regulators.
To plan for future growth, Iovance used a “butterfly” design so that the facility could eventually double its capacity. The building shell is built out for additional core, staging, corridors, incubators, and workstations to mirror the first.
Another first, the iCTC welcomes visitors to explore on-site learning kiosks. Narrated videos describe what visitors are seeing in the viewing windows across from them, for example, employee testimonials, background into the science and data of TIL therapy, and an overview of the manufacturing process. For privacy, Iovance used switchable glazing on viewing windows. With this innovation, a film is placed between two panes of glass. When current is applied, the film turns opaque; when it is removed, the view is clear.
When recognizing Iovance for their accomplishments, the FOYA judges noted, “This autologous therapy approach is not unusual and there are a growing number of these new facilities. However, for Iovance the goal was, ‘to be the first company in the world to commercially produce a personalized one-time cell therapy for solid tumors.’ They are working toward that goal and have an excellent facility as well.”
About Iovance: Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. Their lead, late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Nominate Your Facility for the 2023 FOYA Program!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2023 FOYA program winner. Applications must be submitted by 2 December 2022.
