Abstract: A variable diameter bioreactor vessel is provided that includes a first vessel section having a first diameter configured to hold a liquid media and biologic material, and a second vessel section having a second diameter that is greater than the first diameter such that the liquid media can be increased from a first volume to a second volume within the vessel.

Abstract: A method for producing a purified polyclonal anti-HCP antibody preparation is disclosed. The method can comprise acquiring a sample comprising antibodies from an animal immunized with HCP of a host cell, separating antibodies from the sample by contacting the sample with a protein A affinity reagent to provide an antibody preparation, separating anti-HCP antibody from the antibody preparation by contacting the antibody preparation with an HCP-affinity reagent comprising HCP coupled to a substrate, and isolating the separated polyclonal anti-HCP antibody preparation.

Abstract: The present invention is in the field of recombinant biotechnology, in particular in the field of protein expression. The invention generally relates to a method of expressing a protein of interest (POI) from a host cell. The invention relates particularly to improving a host cell's capacity to express and/or secrete a protein of interest and use of the host cell for protein expression. The invention also relates to cell culture technology, and more specifically to culturing cells to produce desired molecules for medical purposes or food products.

Abstract: Described herein are compositions and methods for identifying, selecting, or culturing cells comprising a subject nucleic acid sequence of interest. Generally, a nucleic acid comprising a subject nucleic acid and a sequence encoding an enzyme molecule involved in biosynthesis of an amino acid is introduced into a cell. The cell is then grown on media lacking the amino acid, such that cells comprising the introduced nucleic acid are capable of growth. In some instances, the cell further comprises an inhibitor of the enzyme molecule to increase the stringency of the selection.

Abstract: The present disclosure is directed to the organic growth and phasing design for a system for the industrial growth of biologics. A system may include a number of subsystems, such as a buffer distribution subsystem, a media preparation subsystem, a bioreactor subsystem, a harvest subsystem, and/or a purification subsystem. The subsystems may be highly interconnected for flexible process flow design. Additionally, the subsystems may be constructed with a total output capacity with a total number of equipment stations and operated at a lower output capacity with fewer than the total equipment stations to maintain headroom for growth in phases.

Abstract: Disclosed are genetic control circuits, cells, and methods that use a repressor polypeptide to reduce the transcription rate of an exogenous therapeutic polypeptide encoding gene in response to a change in condition.

Abstract: A predictive model is described that can predict parameter concentrations in the future based on initial, measured concentrations and historical data. A plurality of multivariate techniques can be used to construct the predictive model capable of forecasting concentrations over multiple and diverse cell lines. The predictive model is also scalable. In one embodiment, a future lactate concentration trajectory is determined and at least one condition within a bioreactor is changed or modified to maintain lactate concentration within desired ranges.

Abstract: The present disclosure features methods and compositions for increasing the amount of products of cellular metabolism, e.g., proteins, by lowering the temperature of cells expressing the product at one or more steps while culturing the cells, expressing the product, and/or recovering the product.

Abstract: Described herein are methods for enhancing the nuclear reprogramming of somatic cells to become induced pluripotent stem cells. In particular, the methods disclosed herein involve the use of damage-associated molecular pattern molecules (DAMP). In certain embodiments the DAMPs are aluminum compositions such as aluminum hydroxide. Such DAMPs have unexpectedly and surprisingly been found to enhance the nuclear reprogramming efficiency of the reprogramming factors commonly used to induce somatic cells to become induced pluripotent stem cells. Accordingly, this disclosure describes methods of nuclear reprogramming as well as cells obtained from such methods along with therapeutic methods for using such cells for the treatment of disease amendable to treatment by stem cell therapy; as well as kits for such uses.

Abstract: A method of producing a protein of interest (POI) by culturing a recombinant eukaryotic cell line comprising an expression construct comprising a regulatable promoter and a nucleic acid molecule encoding a POI under the transcriptional control of said promoter, comprising the steps a) cultivating the cell line with a basal carbon source repressing the promoter, b) cultivating the cell line with a limited amount of a supplemental carbon source de-repressing the promoter to induce production of the POI at a transcription rate of at least 15% as compared to the native pGAP promoter, and c) producing and recovering the POI; and further an isolated regulatable promoter and a respective expression system.

Abstract: The monitoring and control of bioprocesses is provided. More particularly, the present disclosure is directed to formulating buffer products from multiple buffer solutions for feeding the different operations occurring within a bioprocess line. As the buffer product is being formulated, the buffer product is tested for conductivity, refractive index, and optionally pH. The conductivity measurements are used in conjunction with refractive index measurements to ensure that the buffer product not only has the correct concentration of ions but also has the correct concentration of components. A controller can be used to make automatic adjustments to the buffer product should any of the measured parameters fall outside a preset range.

Abstract: A method for delivering a processing solution includes providing a concentrated processing solution in a bioprocess container, the concentrated processing solution being produced at a first site. The method also includes combining the concentrated processing solution with a biopolymer containing solution produced in a bioreactor at a second site different from the first site. In some embodiments, the processing solution is a buffer for processing products of cells cultured in a bioreactor. A system and a pharmaceutical production facility for carrying out the method is also provided.

Abstract: The present disclosure is directed to a big-bag transfer station for API seed crystals. The transfer station may permit the filling of smaller containers, such as bags or pouches, from a large container, such as a big bag. The transfer station may permit the transfer without contaminating the atmosphere of the room in which the station is housed. Additionally, the transfer station may limit cross-contamination between filling cycles by employing single-use liners.

Abstract: A campus for fabricating at least one pharmaceutical product has one or more customizable facilities each configured to manufacture the at least one pharmaceutical product, a media/buffer plant, and a utility building connected by a utility line to the media/buffer plant and/or the one or more customizable facilities to provide at least one first utility to the media/buffer plant and/or the one or more customizable facilities via the utility line.

Abstract: Antibodies having modified constant regions so as to permit conjugation of the antibody to a payload such as a therapeutic agent are described. Preferred antibodies include a mutation at light chain position 180 (positional numbering), most preferably the mutation is to a residue selected from C, K, Q, or a non-natural amino acid. Additional mutations may also be combined with a mutation at position 180; including one or more of light chain (LC) S208, LC S171, LC S182, LC A184, LC V191, LC S202, LC S203, LC T206, heavy chain (HC) S160, HC T190, HC S443, HC S447, HC S139, HC S168, HC V170, HC V176, HC T200, HC S445 according to a positional numbering convention.

Abstract: A mammalian cell comprising at least four distinct recombination target sites (RTS), an adenovirus (Ad) gene comprising E1A, E1B or a combination thereof, and a promoter operatively linked to the Ad gene, wherein the RTS, the Ad gene, and the promoter are chromosomally-integrated; methods for using the cell for generating a recombinant adeno-associated virus (rAAV) producer host cell; and methods for using the AAV producer host cell to produce, package and purify rAAV.

Abstract: A recombinant host cell comprising an endogenous gene encoding a FLO8 protein comprising the amino acid sequence identified as SEQ ID NO:1 or a homologue thereof, which host cell is engineered by one or more genetic modifications to reduce expression of said gene compared to the host cell prior to said one or more genetic modifications, and which host cell comprises a heterologous expression cassette comprising a gene of interest (GO!) under the control of an expression cassette promoter (ECP) which ECP is repressible by a non-methanol carbon source, and a method of producing a protein of interest using said recombinant host cell.

Abstract: An impeller is usable in a variable diameter bioreactor having multiple vessel sections of successively increasing or decreasing volume. The impeller includes an impeller blade extending along an impeller blade axis between first and second axial ends and having opposed impeller blade faces, an impeller blade leading edge, and an impeller blade trailing edge. Each of the leading and trailing edges defines a helix or spiral between the axial ends of the impeller blade. In certain arrangements, the impeller blade is one of at least two impeller blades joined together along an impeller shaft extending axially along the impeller blade axis mentioned, and the helix or spiral has a pitch approximately equal to one half of a length between the first and second axial ends.

Abstract: The present invention is in the field of recombinant biotechnology, in particular in the field of protein expression. The invention generally relates to a method of expressing a protein of interest (POI) from a host cell. The invention relates particularly to improving a host cell's capacity to express and/or secrete a protein of interest and use of the host cell for protein expression. The invention also relates to cell culture technology, and more specifically to culturing cells to produce desired molecules for medical purposes or food products.

Abstract: A predictive model is described that can predict parameter concentrations in the future based on initial, measured concentrations and historical data. A plurality of multivariate techniques can be used to construct the predictive model capable of forecasting concentrations over multiple and diverse cell lines. The predictive model is also scalable. In one embodiment, a future lactate concentration trajectory is determined and at least one condition within a bioreactor is changed or modified to maintain lactate concentration within desired ranges.