Abstract: A syringe having one or more structures or features for maintaining integrity of separation from outside environment is disclosed, the syringe may have a threaded barrel, or a barrel cap, or a needle tip cap configured to allow for inductive sealing against ingress of at least one contaminant. In some embodiments, the barrel cap may include one or more structures for securing the cap to the barrel end by applying a screwing force, a twisting force and/or a snap/press force to the cap.

Abstract: Disclosed herein are compositions, devices, methods, processes, and systems for culturing of large quantities of mammalian cells in suspension culture. Also disclosed are unique and surprising cell populations derived from the disclosed methods, processes, and systems. In many embodiments, the cells are cultured in suspension in liquid culture media that is agitated to maintain the cells in suspension, and agitation increases to maintain cells in suspension while growing and dividing to create cell spheres. The disclosed devices, methods, processes, and systems are useful in tailoring characteristics of the resulting cells based on characteristics of donor subject/initial cells. The disclosed cell populations are useful in treating subjects with cell based therapies in need thereof for various diseases and conditions.

Abstract: Mechanisms are provided for automated medical device regulation risk analysis (MDRRA). An automated MDRRA engine receives compliance rules for a medical device, a data dictionary for a patient data source, and medical device characteristics data for the medical device. The automated MDRRA engine automatically determines, based on the compliance rules and the data dictionary, critical fields of patient data and medical device characteristics data for demonstrating medical device efficacy according to the compliance rules. The automated MDRRA engine automatically determines, based on the critical fields, one or more patient population data subsets for a plurality of patients from a patient population data set and selects a population segment from the one or more patient population data sets to populate an electronic case report form (eCRF) study build. The automated MDRRA engine automatically populates fields of the eCRF with data from the population data sets corresponding to the selected population segment.

Abstract: The disclosed compositions, methods, and devices are useful in freezing, storing, and administering therapeutic eukaryotic cells to a patient in need thereof. In many embodiments, the disclosed therapeutic cells are mammalian cells derived from human intervertebral disc tissue. The disclosed compositions, methods, and devices are able to maintain high viability and sterility of the therapeutic cells, and allow the cells to be administered to a patient directly from the freezing container without manipulation of the cells or transferring to a second container.

Abstract: The invention provides methods, compositions and kits relating to hyaluronan based matrices using oxidized glutathione as a crosslinking agent.

Abstract: The invention provides methods, compositions and kits relating to hyaluronan based matrices using oxidized glutathione as a crosslinking agent.

Abstract: The invention provides methods, compositions and kits relating to hyaluronan based matrices using oxidized glutathione as a crosslinking agent.