Abstract: The present disclosure provides an automated method of producing genetically modified immune cells, including chimeric antigen receptor T (CAR T) cells, utilizing a fully-enclosed cell engineering system.

Abstract: The present disclosure provides methods for assessing and optimizing cellular quality of a cell-based therapy that is being produced in an automated cell engineering system. The methods suitably include monitoring molecular characteristics of the cells before, during, and after the automated process to provide feedback to the process parameters. In embodiments, the cells being produced are Chimeric Antigen Receptor (CAR) T-cells.

Abstract: The present disclosure provides cell culture chambers for use in automated cell engineering systems, and in particular, cell culture chambers that include improved cell-contacting surfaces. Improved cell-contacting surfaces can include a surface coating that promotes cell growth, adherence, differentiation, maintenance of phenotype, and/or improves transduction; a cell-contacting surface comprising a non-porous, gas-permeable material; as well as other modifications to the cell-contacting surfaces. Cassettes comprising the cell culture chambers are also provided.

Abstract: The current disclosure provides methods for reprogramming mammalian somatic cells by regulating the expression of endogenous cellular genes. Cellular reprogramming of somatic cells can be induced by activating the transcription of embryonic stem cell-associated genes (e.g., oct3/4) and suppressing the transcription of somatic cell-specific and/or cell death-associated genes. The endogenous transcription machinery can be modulated using synthetic transcription factors (activators and suppressors), to allow for faster, and more efficient nuclear reprogramming under conditions amenable for clinical and commercial applications. The current disclosure further provides cells obtained from such methods, along with therapeutic methods for using such cells for the treatment of diseases amendable to stem cell therapy, as well as kits for such uses.

Abstract: Disclosed herein are altered adherent stromal cells and methods of producing and utilizing same.

Abstract: The present disclosure provides cassettes for use in automated cell engineering systems that include cell concentration filters for reducing fluid volume of a cell sample during or following automated processing. The disclosure also provides methods of concentrating a cell population, as well as automated cell engineering systems that can utilize the cassettes and carry out the methods.

Abstract: The present disclosure provides cassettes for use in automated cell engineering systems that include cell separation filters for capturing a target cell population for automated processing. The disclosure also provides methods of separating a target cell population, as well as automated cell engineering systems using the cassettes and for carrying out the methods.

Abstract: The present disclosure provides cell therapy production systems that can suitably be used in a patient bedside setting. Such systems allow for direct removal of a patient's blood, automated processing to produce a cell therapy, and then infusion back into the patient, without the need to remove the system from the patient's bedside. Also provided herein are systems for production of cell therapies in a bedside setting.

Abstract: Disclosed herein are altered adherent stromal cells and methods of producing and utilizing same.

Abstract: Provided are methods of controlling disassociation of cells from a carrier, compositions, and methods of collecting cells. The methods of controlling disassociation of cells from a carrier may include contacting a polymeric carrier with one or more digesting agents to disassociate at least a portion of a plurality of cells from the polymeric carrier. The polymeric carrier may be crosslinked with a crosslinker including at least one of a redox sensitive moiety, a UV light sensitive moiety, a pH sensitive moiety, and a temperature sensitive moiety.

Abstract: The present disclosure provides an automated method of producing genetically modified immune cells, including chimeric antigen receptor T (CAR T) cells, utilizing a fully-enclosed cell engineering system.

Abstract: Adherent stromal cells cultured under three dimensional conditions are provided, characterized, and distinguished from adherent stromal cells cultured under two dimensional conditions.

Abstract: The present disclosure provides an automated method of producing genetically modified immune cells, including chimeric antigen receptor T (CAR T) cells, utilizing a fully-enclosed cell engineering system.

Abstract: 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.

Abstract: A perfusion apparatus as disclosed for withdrawing a fluid medium from a bioreactor during the growth of a cell culture on microcarriers within the bioreactor. Also disclosed is a method for culturing cells in a bioreactor contained on microcarriers. The perfusion apparatus includes a hollow tubular member attached to a filter member. The filter member has a pore size and volume capable of withdrawing a fluid medium at a relatively high flow rate from the bioreactor.

Abstract: Methods for treating or preventing preeclampsia or eclampsia by administering adherent stromal cells are described. The adherent stromal cells may be derived from bone marrow, placenta, or adipose tissue. Also described is the use of adherent stromal cells for the manufacture of a medicament, and an article of manufacture comprising a packaging material which comprises a label for use in treating or preventing preeclampsia or eclampsia.

Abstract: The invention relates generally to methods of generating induced pluripotent stem cells (iPSCs) that do not contain the reprogramming vector. In some embodiments, the invention relates to inducing pluripotency in somatic cells by introducing an episomal vector(s) comprising at least one expression cassette containing reprogramming factors and/or synthetic transcription factors and a suicide gene. In some embodiments, the invention relates to inducing pluripotency in somatic cells by introducing episomal vector(s) comprising expression cassettes containing reprogramming factors and/or synthetic transcription factors and a transcriptionally regulated EBNA-1 gene. In some embodiments, the invention relates to inducing pluripotency in somatic cells by introducing episomal vector(s) comprising expression cassettes containing reprogramming factors and/or synthetic transcription factors and both a suicide gene and a transcriptionally regulated EBNA-1 gene.

Abstract: The current disclosure provides methods for reprogramming mammalian somatic cells by regulating the expression of endogenous cellular genes. Cellular reprogramming of somatic cells can be induced by activating the transcription of embryonic stem cell-associated genes (e.g., oct3/4) and suppressing the transcription of somatic cell-specific and/or cell death-associated genes. The endogenous transcription machinery can be modulated using synthetic transcription factors (activators and suppressors), to allow for faster, and more efficient nuclear reprogramming under conditions amenable for clinical and commercial applications. The current disclosure further provides cells obtained from such methods, along with therapeutic methods for using such cells for the treatment of diseases amendable to stem cell therapy, as well as kits for such uses.