Abstract: The present disclosure provides host cells, e.g., bacterial cells, that comprise a methionine decarboxylase enzyme for the treatment of diseases and disorders associated with methionine metabolism in a subject. The disclosure further provides pharmaceutical compositions and methods of treating disorders associated with methionine metabolism, such as homocystinuria.

Abstract: The present disclosure relates to tangential flow filters, membranes, and ultrafiltration membranes, for various applications, including bioprocessing and pharmaceutical applications, systems employing such filters, and methods of filtration using the same. In an aspect, an alternating tangential flow system for continuous processing may include a feed line containing a fluid. A retentate line may be in fluid communication with the feed line. A first diaphragm may be at an inlet of the retentate line configured to pump fluid toward an outlet of the retentate line. A second diaphragm may be at the outlet of the retentate line configured to pump fluid toward the inlet of the retentate line. A membrane may be in fluid communication with the retentate line between the first diaphragm and the second diaphragm. A retentate pump may be at the retentate outlet configured to pump the fluid out of the retentate line.

Abstract: Tangential flow filtration systems utilizing flexible bags for permeate collection are provided.

Abstract: A dual path heat exchanger integrated as a single unit able to process fluid stream through a continuous, single-use high temperature short time process. The heat exchanger contains both a heating section and a cooling section in the same unit. In one embodiment, the heating and cooling sections (which may be formed separately for other uses) are formed as a plate and frame structure with a thermally conductive thin film or foil forming the physical barrier between the process stream flow path and the thermal medium (heating or cooling) flow path. The film/foil renders the heat exchanger suitable for single-use and/or to be disposable. A manifold, which also may be formed as a single unit, may be used to transfer fluid flow between the sections of the heat exchanger, and/or to transfer fluid into and out of the system formed by the heat exchanger and manifold.

Abstract: Tangential flow filtration systems utilizing flexible bags for permeate collection are provided.

Abstract: The present disclosure relates to tangential flow filters, membranes, and ultrafiltration membranes, for various applications, including bioprocessing and pharmaceutical applications, systems employing such filters, and methods of filtration using the same. In an aspect, an alternating tangential flow system for continuous processing may include a feed line containing a fluid. A retentate line may be in fluid communication with the feed line. A first diaphragm may be at an inlet of the retentate line configured to pump fluid toward an outlet of the retentate line. A second diaphragm may be at the outlet of the retentate line configured to pump fluid toward the inlet of the retentate line. A membrane may be in fluid communication with the retentate line between the first diaphragm and the second diaphragm. A retentate pump may be at the retentate outlet configured to pump the fluid out of the retentate line.

Abstract: Cassettes for tangential flow filtration (TFF) are disclosed which reduce assembly and disassembly required for aseptic filtration. Packaging systems and methods for the TFF cassettes are also disclosed.

Abstract: Processes and apparati are provided for separating molecules of interest from a mixture by depth filtration (DF). The DF of the invention is useful in the clarification and processing of various feedstreams for the removal of a molecule of interest. According to a preferred embodiment, a transgenic milk feedstream is stabilized and particulate matter such as fat, casein miscelles and bacteria are removed. An aseptic filtration step was also developed to remove any bacteria remaining in a clarified transgenic milk feedstream.

Abstract: Processes and apparati are provided for separating molecules of interest from a mixture by depth filtration (DF). The DF of the invention is useful in the clarification and processing of various feedstreams for the removal of a molecule of interest. According to a preferred embodiment, a transgenic milk feedstream is stabilized and particulate matter such as fat, casein miscelles and bacteria are removed. An aseptic filtration step was also developed to remove any bacteria remaining in a clarified transgenic milk feedstream.

Abstract: A method is provided for attaching a membrane to a substrate by heat-bonding the membrane to the substrate. The substrate includes a top surface, a bottom surface and a receptacle therethrough. The membrane can be a porous support structure combined with a polymeric gel. The method includes the steps of inserting a mandrel into the receptacle, placing the membrane on the substrate across the receptacle, heating the membrane and substrate, and allowing the substrate to cool to provide heat-bonded interlock between the substrate and the membrane.

Abstract: A self-aliquoting dispensing unit for use with a multi-receptacle storage unit is provided including a lower plate having a plurality of access ports therethrough, wherein at least one of the access ports is in fluid communication with a microtube, an upper plate releasably attached to the lower plate, the upper plate including a sample port for supplying a sample to the dispensing unit, and a sealing member for forming a reversible fluid tight connection between the storage unit and the upper plate. An assembly for dispensing a sample into a multi-receptacle storage unit and a method for dispensing a sample into a multi-receptacle storage unit are also provided.

Abstract: Processes and apparati are provided for separating molecules of interest from a mixture by depth filtration (DF). The DF of the invention is useful in the clarification and processing of various feedstreams for the removal of a molecule of interest. According to a preferred embodiment, a transgenic milk feedstream is stabilized and particulate matter such as fat, casein miscelles and bacteria are removed. An aseptic filtration step was also developed to remove any bacteria remaining in a clarified transgenic milk feedstream.

Abstract: A filtration device having at least one filter packet and a retainer is described. The filter packet includes a membrane having at least a first opening therethrough. The filter packet further includes a retentate screen in fluid communication with the first side of the membrane and a filtrate screen in fluid communication with the second side. The retentate screen includes a permeable material and a seal around an outer perimeter of the permeable material. The permeable material has at least a feed port-defining zone in fluid communication with the first opening. The filtrate screen includes a permeable material and at least a feed port-defining zone in fluid communication with the first opening. The feed port-defining zone of the filtrate screen includes a seal around a perimeter thereof. The filtrate screen has a perimeter open to a filtrate collection area.

Abstract: Methods of purifying MSP-1 from a variety of source materials including from the milk of transgenic mammals.

Abstract: Processes and apparati are provided for separating molecules of interest from a mixture containing them which comprises subjecting the mixture to an improved method of high performance tangential flow filtration (HPTFF). The HPTFF of the invention was used to clarify, and process various feedstreams for the removal of a molecule of interest based on both the size and charge of the molecule of interest. According to a preferred embodiment, a transgenic milk feedstream is stabilized and particulate matter such as fat, casein miscelles and bacteria are removed. The method of HPTFF used in the current invention utilizes optimized process parameters that include temperature, trans-membrane pressure, molecular charge, molecular size, cross-flow velocity, and milk concentration. Cleaning and storage procedures were also developed to ensure long membrane life. An aseptic filtration step was also developed to remove any bacteria remaining in a clarified transgenic milk feedstream.

Abstract: A method is provided for attaching a membrane to a substrate by heat-bonding the membrane to the substrate. The substrate includes a top surface, a bottom surface and a receptacle therethrough. The membrane can be a porous support structure combined with a polymeric gel. The method includes the steps of inserting a mandrel into the receptacle, placing the membrane on the substrate across the receptacle, heating the membrane and substrate, and allowing the substrate to cool to provide heat-bonded interlock between the substrate and the membrane.

Abstract: A self-aliquoting dispensing unit for use with a multi-receptacle storage unit is provided including a lower plate having a plurality of access ports therethrough, wherein at least one of the access ports is in fluid communication with a microtube, an upper plate releasably attached to the lower plate, the upper plate including a sample port for supplying a sample to the dispensing unit, and a sealing member for forming a reversible fluid tight connection between the storage unit and the upper plate. An assembly for dispensing a sample into a multi-receptacle storage unit and a method for dispensing a sample into a multi-receptacle storage unit are also provided.