Across
- 2. specialized, regulated process of collecting, modifying, expanding, and formulating living cells into therapeutic products.
- 6. Cells, tissues, or organs transplanted from a donor to a recipient who is of the same species but genetically distinct.
- 7. a highly controlled, enclosed environment engineered to minimize airborne particles, contaminants, and microbes.
- 10. A medical procedure that uses a specialized machine to separate, remove, or collect specific blood components (such as plasma, platelets, or stem cells) from a donor or patient, returning the remaining blood back to the body.
- 13. a research study involving human volunteers designed to evaluate the safety and effectiveness of new medical approaches, drugs, or devices.
- 14. abbreviation for U.S. federal agency under the Department of Health and Human Services responsible for protecting public health and evaluates clinical trial data to ensure new medicines are safe and effective before they hit the market.
- 15. regulations enforced by the FDA, that ensure pharmaceuticals, medical devices, and food are consistently produced and controlled according to quality standards.
- 16. Process of preserving cells, tissues, or organs by cooling them to extremely low temperatures, typically (using liquid nitrogen), to stop biological activity and allow for future use.
- 17. introduces new, healthy cells into a patient’s body to replace damaged, diseased, or missing cells, or to boost the immune system to fight diseases like cancer.
- 18. the design process of producing a manufacturing platform for a product.
- 20. a field of biomedical science that repairs or replaces damaged tissues and organs to restore normal function.
Down
- 1. the first step in testing a new drug or treatment in humans, focusing primarily on safety, finding the right dose, and identifying side effects.
- 3. Abbreviation for adult somatic cell (such as skin or blood) that have been genetically reprogrammed back into an embryonic-like, pluripotent state.
- 4. A highly efficient, virus-mediated method for transferring genetic material (DNA or RNA) into eukaryotic or prokaryotic cells.
- 5. internationally recognized, voluntary documents that provide requirements, specifications, and guidelines for products, services, processes, and systems.
- 8. Adult, multipotent stromal cells found in bone marrow, fat, and connective tissues.
- 9. Specialized immune cells that act as "sentinels," bridging innate and adaptive immunity by capturing, processing, and presenting antigens on their surface to T cells.
- 11. medicinal products derived from living organisms—such as cells, tissues, or microorganisms—used to treat diseases, often by targeting specific cancer cells or modulating the immune system.
- 12. a system of maintaining standards in manufactured products by testing a sample of the output against the specification.
- 19. the final, mandatory quality control assessment performed on a cell therapy product prior to human administration to ensure it meets predefined specifications for safety, purity, potency, and identity.
- 21. Immunotherapy that genetically modifies a patient’s own T-cells (immune cells) in a lab to recognize and attack cancer cells.