The monitoring and control of bioprocesses is provided. The present disclosure provides the ability to generate generic calibration models, independent of cell line, using inline Raman probes to monitor changes in glucose, lactate, glutamate, ammonium, viable cell concentration (VCC), total cell concentration (TCC) and product concentration. Calibration models were developed from cell culture using two different CHOK1SV GS-KO™ cell lines producing different monoclonal antibodies (mAbs). Developed predictive models, qualified using an independent CHOK1SV GS-KO™ cell line not used in calibration, measured changes in glucose, lactate, ammonium, VCC, and TCC with minor prediction errors over the course of cell culture with minimal cell line dependence. The development of these generic models allows the application of spectroscopic PAT techniques in a clinical manufacturing environment, where processes are typically run once or twice in GMP manufacturing based on a common platform process.

An object of the present invention is to provide a novel method for sorting cardiomyocytes. Another object of the present invention is to provide a method for producing high-purity cardiomyocytes and a kit used therefor. The present invention provides a method for sorting cardiomyocytes, comprising a step of introducing miRNA-responsive mRNA into a cell group, wherein the miRNA-responsive mRNA consists of a sequence comprising the following (i) and (ii): (i) a nucleic acid specifically recognized by miRNA specifically expressed in cardiomyocytes, and (ii) a nucleic acid corresponding to the coding region of a gene, wherein translation of (ii) the nucleic acid corresponding to the coding region of a gene into protein is regulated by the nucleic acid sequence in (i) above, thereby achieving the aforementioned objects.

The high-potential pluripotent stem cells of the present invention not only have characteristics of conventional Muse cells, namely, are capable of differentiating into any embryonic tissue serving as all cells constituting the body, but also are capable of differentiating into any extraembryonic tissue cells such as placenta and/or germline cells, namely, have differentiation capacities close to totipotency. Thus, the high-potential pluripotent stem cells not only allow for conventional regenerative therapies of various diseases which cause any damage in constitution of the body, but also are capable of differentiating into any extraembryonic tissue cells such as placenta, and thus can allow any damaged sites in such any extraembryonic tissue to be re-constituted, resulting in improvement or restoring of the function of such any damaged sites, and can be applied to a new field of regenerative therapy, for example, can be used in reproductive therapies such as fertility therapy.

Aspects of the present invention are drawn to compositions of somatic cells with innate potential for pluripotency (SCIPP). SCIPP have the capacity to differentiate into functional derivatives of each of the major germ layers (i.e., ectodermal, endodermal and mesodermal). Also provided are methods and kits for identifying and isolating the somatic cells from a subject as well as for employing SCIPP for research or therapeutic purposes.

The invention provides genetically modified non-human animals that express chimeric human/non-human T cell co-receptor polypeptides (e.g., CD4, CD8α, CD8β), as well as embryos, cells, and tissues comprising the same. Also provided are constructs for making said genetically modified animals and methods of making the same.

A method for characterizing stem cell differentiation includes harvesting differentiation media supernatant containing secreted analytes from key time points during a stem cell differentiation, performing at least one of a qualitative and a quantitative analysis of the differentiation media supernatant with respect to at least one secreted analyte, and identifying trends in analyte expression based on at least one of the qualitative and quantitative analysis of the differentiation media supernatant.

The present invention is provides a method for treating human pluripotent cells. In particular, the methods of the invention are directed to the treatment of human pluripotent cells, whereby the human pluripotent cells can be efficiently expanded in culture and differentiated by treating the pluripotent cells with an inhibitor of glycogen synthase kinase 3β (GSK-3B) enzyme activity.

Genetically modified cells that are compatible with multiple subjects, e.g., universal donor cells, and methods of generating said genetic modified cells are provided herein. The universal donor cells comprise at least one genetic modification within or near at least one gene that encodes one or more MHC-I or MHC-II human leukocyte antigens or component or transcriptional regulator of the MHC-I or MHC-II complex, at least one genetic modification that increases the expression of at least one polynucleotide that encodes a tolerogenic factor, and optionally at least one genetic modification that increases or decreases the expression of at least one gene that encodes a survival factor.

A non-freezing refrigerated storage liquid for stem cells such as iPS cells, according to an embodiment, comprises: potassium ion species in a range of 30 to 80 mmoL/L; sodium ion species in a range of 30 to 80 mmoL/L, wherein ion-based molar ratio of sodium ion species to potassium ion species (ratio ofNa.sup.+ to K.sup.+) is in a range of 0.5 to 1.3; trolox or its analog at a concentration of 1 to 8 mM; adenine or a salt or derivative thereof at a concentration of 0.1 to 4.2 mM; all of or all but one, two or three of essential amino acids, total content of which is 50 to 200 mg; and non-essential amino acids, total content of which is 50 to 200 mg/L.

The disclosure provides nonsteroidal anti-inflammatory compositions and methods of use thereof. Specifically, the disclosure provides cell-free or substantially cell-free regenerative nonsteroidal anti-inflammatory compositions derived from placenta and/or from MSC cells isolated therefrom, methods for producing said compositions, and uses thereof to treat chronic and acute inflammatory conditions and diseases.