Solon, Ohio-based Saint-Gobain Performance Plastics has opened a life sciences lab in Worcester, Mass., for testing products in the fast-growing market for cell and gene therapies.
Living cells are essentially a new class of drugs thanks to recent advances like CAR-T cell therapy, which allows scientists to modify a patient's immune cells and send them back into the person to detect and destroy cancer. Targeting the immune system instead of the disease represents a paradigm shift in treating cancer and other life-threatening diseases.
Saint-Gobain's Performance Plastics business unit produces a variety of disposable products for these promising new therapies, including cell culture and processing bags branded as VueLife and cryopreservation products branded as KryoSure that are made mostly from flourinated ethylene propylene (FEP). The company is also developing new products for this field.
The Worcester lab is dedicated to learning more about cell and material interactions for designing single-use systems for cell and gene therapies, Benjamin Le Quere, manager of Saint-Gobain's Bioprocess Solutions, said in a phone interview.
"Saint-Gobain has a long history around high-performance materials, including fluoropolymers," Le Quere said. "Now we're adding this layer of biology to better relate what our materials do to the application of the customer, which in this case is biotech drug manufacturers."
This emerging field of medicine has specific needs when it comes to ensuring patient safety through validated processes and materials in drug manufacturing, Le Quere said.
"In cases where a biotech company takes the cells of a patient, and in a way, trains the cells to fight diseases, such as cancer, and puts them back into the same patient, you have manufacturing concerns," he added.
The best practices for manufacturing and distributing personalized medicines, which are developed with genetic material in gene therapy or whole cells in cell therapy and sometimes overlap, are still unfolding. Any problems or challenges could affect the commercial and clinical viability of these precious products.
"Logistics for these therapies is an open problem," Le Quere said.
Consider all the steps and people involved with a cell-based gene therapy branded as Kymriah, which last August became the first CAR-T cell therapy approved by the Federal Drug Administration. Unlike other medicines, Kymriah has been likened to your body using your own strength to fight your cancer. The therapy is given to patients under the age of 25 who relapsed or aren't responding to initial treatments for B-cell acute lymphoblastic leukemia, an aggressive deadly type of cancer for some.
Kymriah requires a lengthy process with various settings, handlers and containers, including dedicated containers for storage and transport as well as disposable containers, like culture bags, for the manufacturing process. The therapy takes about a month, starting with the patient going to a medical center for a blood draw to collect T cells, the natural defender of the immune system. The cells are then frozen and shipped to the drug manufacturer — in this case Novartis Pharmaceutical Corp. in New Jersey, for reprogramming and multiplying. Then the cells, which have been altered to attack cancer, are frozen again and sent back to the medical center to be placed back into the patient through an IV infusion.
In a trial involving 63 severely ill children and young adults, 83 percent went into remission from their customized treatments, which are given once at a cost of about $475,000. (For comparison, bone marrow transplants, which can cure some kinds of leukemia, generally range from $540,000 to $800,000.)
To help advance these kinds of therapies at its new 1,400-square-foot Biosafety Level 2 lab, Saint-Gobain staff will isolate, process and culture both primary and so-called immortalized cells then evaluate material, cell and protein interactions. They will study the effects of materials on cell attributes and yields using high-end analytical equipment. The facility also devotes space to develop applications for new products and has capabilities for sterile welding, pumping and low temperature testing.
The lab is located on the campus of the University of Massachusetts Medical School, but Saint-Gobain and the university aren't research partners. The site was chosen because the company has a research and development facility in nearby Northboro.
"This lab is an annex of that," Le Quere said. "The purpose is to understand what our products do to the end-use application. We're trying to bridge that gap of understanding between materials and biology."