Abstract: Systems and methods are disclosed for process simulation in a cell processing facility. Example methods for processing a patient sample may include recording an identifier code unique to a patient as a unique identifier in a database patient record, collecting a patient sample into a patient sample collection component, checking the sample collection component identity code against a component registry to confirm the correct component (106, 109) is being used for that stage in processing, characterised by: adding the sample collection component identity code as an entry to a custody chain of component identity codes in the patient record, following sample collection, transferring the collection component containing the patient sample to the next operation in the processing where a processing step is performed using a processing component specific to that stage of the processing, and checking the processing component identity code of the specific processing component against the component registry.

Abstract: The present disclosure relates to cell processing techniques. By way of example, a cell processing system may include a plurality of sample processing devices configured to process patient samples and a plurality of readers respectively associated with the plurality of sample processing devices, wherein each reader is configured to read information from tracking devices associated with respective patient samples. The system may also include a controller that uses information from the readers to provide an estimated completion time for a patient sample based on availability of the sample processing devices.

Abstract: The invention discloses a method for determining a nucleotide sequence of a nucleic acid segment present in a biological sample, comprising the steps of: a) generating a fluorescent image of the sample by a protocol comprising immunofluorescence detection of at least five different target proteins in the sample; b) selecting a region of interest of the sample by comparing the image to a predetermined criterion; c) removing a subsample from the region of interest, and; d) determining a nucleotide sequence of a nucleic acid segment present in the subsample.

Abstract: The present disclosure relates to cell processing techniques. By way of example, a cell processing system may include a plurality of tracking devices coupled to a respective plurality of sample processing containers and storing sample identification information for a patient sample for use with sample processing devices configured to process the patient sample according to workflow steps of a processing protocol. A plurality of readers are configured to receive signals from the plurality of tracking devices. A controller may be coupled to the plurality of readers and configured to determine if the patient sample is processed according to the processing protocol based at least in part on the signals from the plurality of tracking devices.

Abstract: A method of eluting biomolecules, such as nucleic acids from a biological sample by electroelution is provided. An example of a method includes various steps, such as loading the biological sample to a device comprising a housing, at least two conductive redox polymer electrodes operationally coupled to the housing and a biomolecule impermeable layer disposed on at least one of the electrodes. The loading of sample is followed by initiating an electrical connection to generate an electric field strength sufficient to elute biomolecules from the biological sample; and eluting the biomolecules from the biological sample.

Abstract: The present invention provides improved methods, facilities and systems for parallel processing of biological cellular samples in an efficient and scalable manner. The invention enables parallel processing of biological cellular samples, such as patient samples, in a space and time efficient fashion. Process simulation may be used to determine the optimal arrangement and/or quantity of cell processing equipment needed. The methods, facilities and systems of the invention find particular utility in processing patient samples for use in cell therapy.

Abstract: A method is provided for generating single-stranded DNA circles from a biological sample. The method comprises the steps of: treating the biological sample with an extractant to release nucleic acids, thereby forming a sample mixture; neutralizing the extractant; denaturing the released nucleic acids to generate single-stranded nucleic acids; and contacting the single-stranded nucleic acids with a ligase that is capable of template-independent, intramolecular ligation of single-stranded DNA to generate the single-stranded DNA circles. All the steps of the method are performed without any intermediate nucleic acid isolation or nucleic acid purification. The single-stranded DNA circles may be amplified and further analyzed. Also provided is a kit which comprises compositions for carrying out the novel methods.

Abstract: Method and systems, for processing biological material, that contain a biological material in a vessel; add an aggregating agent to the material in the vessel and allow the material to separate into two or more distinct submaterials; extract one or more of the submaterials from the vessel; automatically transport one or more of the submaterials remaining in the vessel to a filtration device; and collect a resulting target retentate into a target retentate receptacle.

Abstract: The present disclosure relates to cell processing techniques. By way of example, a cell processing system may include a plurality of tracking devices coupled to a respective plurality of sample processing containers and storing sample identification information for a patient sample for use with sample processing devices configured to process the patient sample according to workflow steps of a processing protocol. A plurality of readers are configured to receive signals from the plurality of tracking devices. A controller may be coupled to the plurality of readers and configured to determine if the patient sample is processed according to the processing protocol based at least in part on the signals from the plurality of tracking devices.

Abstract: The present disclosure relates to cell processing techniques. By way of example, a cell processing system may include a plurality of sample processing devices configured to process patient samples and a plurality of readers respectively associated with the plurality of sample processing devices, wherein each reader is configured to read information from tracking devices associated with respective patient samples. The system may also include a controller that uses information from the readers to provide an estimated completion time for a patient sample based on availability of the sample processing devices.

Abstract: The invention discloses a method for determining a nucleotide sequence of a nucleic acid segment present in a biological sample, comprising the steps of: a) generating a fluorescent image of the sample by a protocol comprising immunofluorescence detection of at least five different target proteins in the sample; b) selecting a region of interest of the sample by comparing the image to a predetermined criterion; c) removing a subsample from the region of interest, and; d) determining a nucleotide sequence of a nucleic acid segment present in the subsample.

Abstract: A device and a system for eluting biomolecules from biological sample by electroelution are provided. The device for electroelution of biomolecules from a biological sample is constituted with a housing configured to receive an electrolyte and the biological sample, at least two electrodes comprising conductive redox polymers operationally coupled to the housing, and a biomolecule impermeable layer disposed on at least one of the electrodes. The biomolecule impermeable layer disposed on at least one of the electrodes to prevent the biomolecules from reaching the electrode. A system is provided, wherein the system comprises a sample collection port, one or more reservoirs comprising a buffer, a solvent, a reagent or combinations thereof, an device for electroelution, and a controller.

Abstract: A method of eliciting an immune response in an organism comprising: providing an unprocessed rolling circle amplification (RCA) product; and administering an effective amount of the unprocessed RCA product to the organism to elicit the immune response, wherein the unprocessed RCA product is prepared from a circular nucleic acid template comprising at least one promoter sequence, and at least one target sequence. A vaccine comprising unprocessed RCA product is also provided and methods for making the same.

Abstract: Method and systems, for processing biological material, that contain a biological material in a vessel; add an aggregating agent to the material in the vessel and allow the material to separate into two or more distinct submaterials; extract one or more of the submaterials from the vessel; automatically transport one or more of the submaterials remaining in the vessel to a filtration device; and collect a resulting target retentate into a target retentate receptacle.

Abstract: Method and systems, for processing biological material, that contain a biological material in a vessel; add an aggregating agent to the material in the vessel and allow the material to separate into two or more distinct submaterials; extract one or more of the submaterials from the vessel; automatically transport one or more of the submaterials remaining in the vessel to a filtration device; and collect a resulting target retentate into a target retentate receptacle.

Abstract: A method of eluting biomolecules, such as nucleic acids from a biological sample by electroelution is provided. An example of a method includes various steps, such as loading the biological sample to a device comprising a housing, at least two conductive redox polymer electrodes operationally coupled to the housing and a biomolecule impermeable layer disposed on at least one of the electrodes. The loading of sample is followed by initiating an electrical connection to generate an electric field strength sufficient to elute biomolecules from the biological sample; and eluting the biomolecules from the biological sample.

Abstract: A device and a system for eluting biomolecules from biological sample by electroelution are provided. The device for electroelution of biomolecules from a biological sample is constituted with a housing configured to receive an electrolyte and the biological sample, at least two electrodes comprising conductive redox polymers operationally coupled to the housing, and a biomolecule impermeable layer disposed on at least one of the electrodes. The biomolecule impermeable layer disposed on at least one of the electrodes to prevent the biomolecules from reaching the electrode. A system is provided, wherein the system comprises a sample collection port, one or more reservoirs comprising a buffer, a solvent, a reagent or combinations thereof, an device for electroelution, and a controller.

Abstract: Methods and kits for generating circular nucleic acids in a cell-free system, and uses for the generated circular nucleic acids are provided. The methods comprise in vitro amplification of a nucleic acid template comprising a recombination site to produce tandem repeat nucleic acid sequence, and employ a recombination protein to generate the circular nucleic acids from the tandem repeat nucleic acid sequence.

Abstract: The invention provides a method of manufacturing a housingless hollow fiber filtration apparatus using batch, continuous, and semi-continuous processes. Also provided is manufacturing methods to increase rigidity of the apparatus.

Abstract: A method of eliciting an immune response in an organism comprising: providing an unprocessed rolling circle amplification (RCA) product; and administering an effective amount of the unprocessed RCA product to the organism to elicit the immune response, wherein the unprocessed RCA product is prepared from a circular nucleic acid template comprising at least one promoter sequence, and at least one target sequence. A vaccine comprising unprocessed RCA product is also provided and methods for making the same.