Abstract: The present invention pertains to a cell culture medium comprising copper as a media supplement, which was shown to control recombinant protein glycosylation and methods of sing thereof. The present invention further pertains to a method of controlling or manipulating glycosylation of a recombinant protein of interest in a large scale cell culture.

Abstract: The present invention pertains to a cell culture medium comprising copper as a media supplement, which was shown to control recombinant protein glycosylation and methods of sing thereof. The present invention further pertains to a method of controlling or manipulating glycosylation of a recombinant protein of interest in a large scale cell culture.

Abstract: Devices for delivering and deploying a prosthesis are disclosed and comprise a sheath, a prosthesis disposed within a distal end portion of the sheath, and a wire having a first end coupled to the prosthesis and a second end coupled to the sheath. A body portion of the wire comprises a slack in the wire, and the sheath, prosthesis, and wire are configured so that a proximal movement of the sheath relative to the prosthesis reduces the slack in the wire, and a subsequent proximal movement of the sheath relative to the prosthesis decouples the wire from the prosthesis. Additional devices, systems, and methods are disclosed.

Abstract: A prosthesis delivery device and method of using the same is described. The delivery device comprises a rotatable inner cannula extending from a proximal end to a distal end with a prosthesis releasably coupled to the proximal end. A delivery handle assembly is disposed at the distal end of the delivery device. The handle comprises a first handle disposed about the inner cannula, a rotary dial rotatably disposed about a distal end of the first handle and a second handle disposed about at least a portion of the distal end of the first handle. The second handle is longitudinally moveable relative to the first handle between a first position wherein the sheath is coaxially disposed about the prosthesis and rotation of the rotary dial is prevented, and a second position wherein the sheath is retracted distally to expose at least a portion of the prosthesis and rotation of the dial is permitted.

Abstract: Devices for delivering and deploying a prosthesis are disclosed and comprise a sheath, a prosthesis disposed within a distal end portion of the sheath, and a wire having a first end coupled to the prosthesis and a second end coupled to the sheath. A body portion of the wire comprises a slack in the wire, and the sheath, prosthesis, and wire are configured so that a proximal movement of the sheath relative to the prosthesis reduces the slack in the wire, and a subsequent proximal movement of the sheath relative to the prosthesis decouples the wire from the prosthesis. Additional devices, systems, and methods are disclosed.

Abstract: A prosthesis delivery device and method of using the same is described. The delivery device comprises a rotatable inner cannula extending from a proximal end to a distal end with a prosthesis releasably coupled to the proximal end. A delivery handle assembly is disposed at the distal end of the delivery device. The handle comprises a first handle disposed about the inner cannula, a rotary dial rotatably disposed about a distal end of the first handle and a second handle disposed about at least a portion of the distal end of the first handle. The second handle is longitudinally moveable relative to the first handle between a first position wherein the sheath is coaxially disposed about the prosthesis and rotation of the rotary dial is prevented, and a second position wherein the sheath is retracted distally to expose at least a portion of the prosthesis and rotation of the dial is permitted.

Abstract: The present disclosure shows, unexpectedly, that variations in cell culture performance in large-scale cell culture systems such as, for example, those used in commercial manufacturing processes, in some instances, can be attributed to often subtle variations among shear-protectant additives used during cell culture. Assessing the quality of shear-protective additives using such large-scale systems, however, is inaccurate, time-consuming and costly. To solve the problem identified, the present disclosure provides methods and compositions for evaluating the suitability of shear-protectant additives without resorting to large scale cell growth and/or protein production tests.

Abstract: There is disclosed, among other things, embodiments of a biopsy needle for taking a full core sample through soft tissue. In the illustrated embodiments, an inner tubular member having a semi-cylindrical distal end is within and slidable with respect to an outer tubular member. A semi-cylindrical channel is in the distal end, as well as a planar end surface. The channel has a set of one or more protrusions or texture, and a complementary set of protrusions or texture are placed on the inside of the outer member so that the sets of protrusions or texture face each other when the distal ends of the members are adjacent each other. Methods for using these embodiments are also described.

Abstract: The present invention provides improved methods for the reduction or removal of protein impurities from a complex cellular Streptococcus pneumoniae lysate or centrate comprising serotype 3 polysaccharides involving steps relating to post-lysis heating or pH adjustment. In certain methods, the lysate is heated for a time and at a temperature sufficient to denature proteins present in the lysate and cause their aggregation and precipitation. In one embodiment, the lysate is heated to at least 60° C. for at least 30 minutes to cause protein aggregation and precipitation, more particularly about 60° C. to about 70° C. for about 30 to about 50 minutes, and even more particularly about 65° C. for about 40 minutes. In other methods, the pH of the lysate or centrate is increased to at least 8.0 to improve filterability, more particularly about 8.0 to 8.4, and even more particularly about 8.2.