Abstract: The present disclosure relates to implantable encapsulation devices for housing a biological moiety or a therapeutic device that contains a biological moiety. Particularly, aspects of the present disclosure are directed to an implantable apparatus that includes a distal end, a proximal end, a manifold including at least one access port positioned either at the distal end or the proximal end, and a plurality of containment tubes affixed to the manifold and in fluid communication with the at least one access port. Additionally, the encapsulation device may contain a flush port and a tube that are fluidly connected to the manifold. The containment tubes may contain therein a biological moiety (e.g., cells) or a therapeutic device (e.g. a cell encapsulation member).

Abstract: The present disclosure is directed to affinity chromatography devices that include a fibrillated heat treated polymer membrane that contains therein inorganic particles that separate a targeted molecule from an aqueous mixture containing the targeted molecule. The targeted molecule includes proteins, antibodies, viral vectors, nucleic acids, and combinations thereof. The inorganic particles may be spherical or irregular in shape. A blend or combination of various sizes and/or shapes of inorganic particles may be utilized. An affinity ligand may be bonded to the inorganic particles and/or to the fibrillated polymer membrane. The affinity chromatography device may be repeatedly used and may be cleaned between uses. In some embodiments, the affinity chromatography devices separate nucleic acids (e.g., mRNA) and viral vectors (e.g., adeno-associated virus) from the aqueous mixture.

Abstract: The present disclosure is directed to affinity chromatography devices that include a fibrillated polymer membrane that contains therein inorganic particles that separate a targeted molecule from an aqueous mixture containing the targeted molecule. The targeted molecule includes proteins, antibodies, viral vectors, nucleic acids, and combinations thereof. The inorganic particles may be spherical or irregular in shape. A blend or combination of various sizes and/or shapes of inorganic particles may be utilized. An affinity ligand may be bonded to the inorganic particles and/or to the fibrillated polymer membrane. The affinity chromatography device may be repeatedly used and may be cleaned between uses. In some embodiments, the affinity chromatography devices separate nucleic acids (e.g., mRNA) and viral vectors (e.g., adeno-associated virus) from the aqueous mixture.

Abstract: Cell encapsulation devices for biological entities and/or cell populations that contain at least one biocompatible membrane composite are provided. The cell encapsulation devices mitigate or tailor the foreign body response from a host such that sufficient blood vessels are able to form at a cell impermeable surface. Additionally, the encapsulation devices have an oxygen diffusion distance that is sufficient for the survival of the encapsulated cells so that the cells are able to secrete a therapeutically useful substance. The biocompatible membrane composite is formed of a cell impermeable layer and a mitigation layer. The cell encapsulation device maintains an optimal oxygen diffusion distance through the design of the cell encapsulation device or through the use of lumen control mechanisms. Lumen control mechanisms include a reinforcing component that is also a nutrient impermeable layer, internal structural pillars, internal tensioning member(s), and/or an internal cell displacing core.

Abstract: A biocompatible membrane composite that can provide an environment that is able to mitigate or tailor the foreign body response is provided. The membrane composite contains a mitigation layer and a vascularization layer. A reinforcing component may optionally be included to provide support to and prevent distortion of the biocompatible membrane composite in vivo. The mitigation layer may be bonded (e.g., point bonded or welded) or adhered (intimately or discretely) to an implantable device and/or cell system. The biocompatible membrane composite may be used as a surface layer for implantable devices or cell systems that require vascularization for function but need protection from the host's immune response, such as the formation of foreign body giant cells. The biocompatible membrane composite may partially or fully cover the exterior of an implantable device or cell system. The mitigation layer is positioned between the implantable device or bioactive scaffold and the vascularization layer.

Abstract: The present disclosure relates to implantable encapsulation devices for housing a biological moiety or a therapeutic device that contains a biological moiety. Particularly, aspects of the present disclosure are directed to an implantable apparatus that includes a distal end, a proximal end, a manifold including at least one access port positioned either at the distal end or the proximal end, and a plurality of containment tubes affixed to the manifold and in fluid communication with the at least one access port. Additionally, the encapsulation device may contain a flush port and a tube that are fluidly connected to the manifold. The containment tubes may contain therein a biological moiety (e.g., cells) or a therapeutic device (e.g. a cell encapsulation member).

Abstract: A storage bag configured to contain or that contains at least one therapeutic compound such as a viral vector and non-viral vector is provided. In one embodiment, the storage bag contains a viral vector and/or a non-viral vector containing genetic material. The storage bag has two edges and two ends including a first face and a second face integrally joined at the two edges of the bag and defining an inner surface and an outer surface forming the bag; the inner surface including a higher melting polymer, and the outer surface including a lower melting polymer; a joint at one of the ends; a discrete composite sheet having a first side including a higher melting polymer and a second side including a lower melting polymer folded over the joint with the first side including a lower melting polymer engaging the joint to form a lap seam over the joint.

Abstract: The present disclosure relates to implantable encapsulation devices for housing a biological moiety or a therapeutic device that contains a biological moiety. Particularly, aspects of the present disclosure are directed to an implantable apparatus that includes a distal end, a proximal end, a manifold including at least one access port positioned either at the distal end or the proximal end, and a plurality of containment tubes affixed to the manifold and in fluid communication with the at least one access port. Additionally, the encapsulation device may contain a flush port and a tube that are fluidly connected to the manifold. The containment tubes may contain therein a biological moiety (e.g., cells) or a therapeutic device (e.g. a cell encapsulation member).

Abstract: The present disclosure relates to implantable encapsulation devices for housing a biological moiety or a therapeutic device that contains a biological moiety. Particularly, aspects of the present disclosure are directed to an implantable apparatus that includes a distal end, a proximal end, a manifold including at least one access port positioned either at the distal end or the proximal end, and a plurality of containment tubes affixed to the manifold and in fluid communication with the at least one access port. Additionally, the encapsulation device may contain a flush port and a tube that are fluidly connected to the manifold. The containment tubes may contain therein a biological moiety (e.g., cells) or a therapeutic device (e.g. a cell encapsulation member).

Abstract: A storage bag configured to contain or that contains at least one therapeutic compound such as a viral vector and non-viral vector is provided. In one embodiment, the storage bag contains a viral vector and/or a non-viral vector containing genetic material. The storage bag has two edges and two ends including a first face and a second face integrally joined at the two edges of the bag and defining an inner surface and an outer surface forming the bag; the inner surface including a higher melting polymer, and the outer surface including a lower melting polymer; a joint at one of the ends; a discrete composite sheet having a first side including a higher melting polymer and a second side including a lower melting polymer folded over the joint with the first side including a lower melting polymer engaging the joint to form a lap seam over the joint.

Abstract: The present disclosure relates to implantable encapsulation devices for housing a biological moiety or a therapeutic device that contains a biological moiety. Particularly, aspects of the present disclosure are directed to an implantable apparatus that includes a distal end, a proximal end, a manifold including at least one access port positioned either at the distal end or the proximal end, and a plurality of containment tubes affixed to the manifold and in fluid communication with the at least one access port. Additionally, the encapsulation device may contain a flush port and a tube that are fluidly connected to the manifold. The containment tubes may contain therein a biological moiety (e.g., cells) or a therapeutic device (e.g. a cell encapsulation member).

Abstract: Laminates suitable for constructing waterproof and breathable articles such as protective clothing which are both comfortable and exhibit enhanced resistance to fire are described. Particularly, flame resistant laminate constructions are described comprising a meltable textile as the outermost layer laminated to an intermediate protective layer comprising a waterproof film laminated to an innermost fabric layer comprising a thermally stable textile. Laminate constructions of the present invention exhibit breathability on the order of at least 1000 MVTR, a water entry pressure of at least 0.5 psi and have a horizontal flame break open time of at least 10 seconds.

Abstract: Laminates suitable for constructing waterproof and breathable articles such as protective clothing which are both comfortable and exhibit enhanced resistance to fire are described. Particularly, flame resistant laminate constructions are described comprising a meltable textile as the outermost layer laminated to an intermediate protective layer comprising a waterproof film laminated to an innermost fabric layer comprising a thermally stable textile. Laminate constructions of the present invention exhibit breathability on the order of at least 1000 MVTR, a water entry pressure of at least 0.5 psi and have a horizontal flame break open time of at least 10 seconds.

Abstract: A fabric body or textile comprising a cable or interconnect capable of transmitting data or power is secured to the fabric body or textile surface by a tape. Methods for securing the cable or interconnect system include, for example, garment taping processes. Fabric bodies having the taped cable or interconnect are highly flexible, wash durable and unobtrusive to the user.

Abstract: A fabric body or textile comprising a cable or interconnect capable of transmitting data or power is secured to the fabric body or textile surface by a tape. Methods for securing the cable or interconnect system include, for example, garment taping processes. Fabric bodies having the taped cable or interconnect are highly flexible, wash durable and unobtrusive to the user.