MaSTherCell’s Innovative Cell Soldiers Infiltrate Webster
New advances in cell and gene therapies are transforming and revolutionizing medicines for treating and curing critical diseases, like leukemia, diabetes, and blood cancers. Since 2011, MaSTherCell, a renowned, global cell and gene therapy Contract Development Manufacturing Organization (CDMO), based in Belgium, has been pioneering and advancing sustainable and affordable therapies for intractable diseases by extracting cells from patients or donors, altering those specimens in highly controlled laboratories that are many times cleaner than a surgical lab, and re-injecting the new cells into patients to combat diseased or compromised cells. Cell and gene therapy works. “Soldier” cells and “soldier” genes are developed, manufactured, and tested by MaSTherCell to attack cancer and other maladies.
MaSTherCell opened its United States headquarters in Webster at 253 Medical Center Boulevard in August 2019 to expand its world presence and provide direct, fast, and comprehensive interaction, consulting, and collaboration with key American-based cell and gene therapy companies—many of which conduct clinical trials in the nearby Texas Medical Center—the largest medical complex on the globe. Webster’s central location within the United States enables time-sensitive cell therapy products to reach any mainland destination quite rapidly—ensuring excellent logistics for live cells. Too, Webster’s proximity to growing life science and biotechnology industries is highly beneficial for ensuring access to a highly skilled workforce and top-notch support services.
MaSTherCell represents the “D” (development) in “R & D” (research and development). When therapy discovery companies seek to develop their process for manufacturing, in accordance with the FDA’s Good Manufacturing Practice standards—and, ultimately, launch their products more rapidly and effectively, they contract with MaSTherCell, as the steps from research to development or concept to manufacturing are fraught with rigorous, regulatory, and complex processes. MaSTherCell’s team of industrial, scientific, and operational experts with credentials in industrial biotechnology, biochemistry, molecular biology, and biomedical science provide technology transfer, process and analytical development, clinical manufacturing, regulatory support, and quality oversight to customers.
A tour of MaSTherCell’s magnificent, state of the art Webster facility illuminates some of the extraordinary processes that the company undergoes to manufacture its customers’ cell and gene therapies. Inside the 32,000 square foot facility, the entire second floor features a suite of labs, including the process development/technology transfer laboratories, quality control, microbiology and cell culture laboratories, and multiple manufacturing suites. All of these labs and cleanrooms, designed under the most exacting and precise standards to support both autologous (utilizing the patient’s own cells) and allogenic cells (utilizing cell sources unrelated to the patient) are continually controlled and monitored, as part of MaSTherCell’s robust Quality Management System, in conjunction with approximately 1,000 pieces of equipment. The eight manufacturing cleanrooms, clustered with their expansive glass exteriors, are surrounded by a spacious walkway that allows clients and visitors the opportunity to view activity—activity that leads to saving lives.
Success stories for cell therapy include toddlers diagnosed with pediatric acute lymphoblastic leukemia, middle-aged men with chronic lymphocytic leukemia or young women with acute lymphoblastic leukemia.
Patients who have blood cancer provide T-cells (workhorses of the immune system) that MaSTherCell isolates in the manufacturing site and inserts chimeric antigen receptor (CAR) and grows the cells—“soldier” cells or new CAR-T cells—to combat the disease. Those new cells, known as chimeric immunoreceptors, have been engineered to give T-cells the ability to target a specific protein and act as a “living drug” against cancer cells when they are infused back into the patient following a four-to-twelve week process that includes the most rigorous testing and validations. With CAR-T-cell therapy, cells can be derived from a patient’s own blood (autologous) or derived from the T-cells of another healthy donor (allogeneic). CAR-T cells are genetically engineered to target and destroy cancer cells.
MaSTherCell is part of an explosive, fast growing industry focused on biologic treatment derived from living cells, DNA, and “natural” sources, in contrast to pharmaceuticals derived from chemical synthesis. Too, the potential applications for cell and gene therapy—immunotherapy—continue to unfold. While CAR-T therapy has proven to be life-changing for patients with blood cancers, inroads are being made for solid tumors, like breast, colorectal, and lung cancer. Currently, two CAR-T-cell therapies have been approved by the FDA, while there are 1,000 potential therapies in labs, right now.
MaSTherCell Webster is positioned for this growth with its focus on agility, transparency, engagement, team spirit, and innovation, amid a culture that is directly tied to the company’s mission, “Saving Lives.” Inside the Webster facility, patients’ photographs, with their diagnoses and successful cell therapy, are in the spotlight with MaSTherCell’s slogan, “Every Second Counts!”