Abstract: Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.

Abstract: A patient ventilating (23) and aspirating system (8) is disclosed that has a suction tube (9) and connector (6) for connecting to a catheter mount that has a sealed passageway (15) The catheter mount passageway (15) is sealed with an elastomeric seal (16) including a perforation or slit (17). A connector (12) with a piercing member is associated with the suction tube (9). When the connector is attached to the catheter mount the piercing member (20) pierces the seal (16) such that the suction tube (9) can pass through the connector (6) and catheter mount.

Abstract: Methods and systems for sorting hides are provided. In particular, one or more embodiments comprise a tanning control system that enhances the traceability of hides by capturing and utilizing data related to the unloading, tanning, sorting, and packaging of hides. Furthermore, one or more embodiments enable the tanning control system to improve efficiency by sorting hides based, at least in part, on data generated during prior tanning processes. Additionally, one or more embodiments facilitate the tanning control system in customizing the sorting and packaging of hides based, at least in part, on one or more hide characteristics and/or customer specifications.

Abstract: Ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided suitable for intravitreal administration to the eye. The ophthalmic formulations include a stable liquid formulation and a lyophilizable formulation. Preferably, the protein antagonist has an amino acid sequence of SEQ ID NO:4.

Abstract: Methods and systems for sorting hides are provided. In particular, one or more embodiments comprise a tanning control system that enhances the traceability of hides by capturing and utilizing data related to the unloading, tanning, sorting, and packaging of hides. Furthermore, one or more embodiments enable the tanning control system to improve efficiency by sorting hides based, at least in part, on data generated during prior tanning processes. Additionally, one or more embodiments facilitate the tanning control system in customizing the sorting and packaging of hides based, at least in part, on one or more hide characteristics and/or customer specifications.

Abstract: Ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided suitable for intravitreal administration to the eye. The ophthalmic formulations include a stable liquid formulation and a lyophilizable formulation. Preferably, the protein antagonist has an amino acid sequence of SEQ ID NO:4.

Abstract: Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.

Abstract: Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.

Abstract: Mask assemblies, breathing circuits and related components include configurations for reducing condensation within the mask and/or inhibiting or preventing condensation from coming into contact with a user of the mask. The mask assemblies can incorporate heating elements (such as heating coils), insulating spaces or barrier layers.

Abstract: This invention provides for a component forming a part of a breathing tube, or forming the breathing tube, for example as a part of a breathing circuit for respiratory therapy. The component comprising a tubular body having a foamed wall. The foamed wall can be formed from extrusion of a single extrudate. The foamed wall is of a sufficient minimum optical transparency such that, in use, there is enabled the visual detection of a liquid (or condensate that may have formed) within the tubular body.

Abstract: The present invention provides stable liquid pharmaceutical formulations comprising a human bispecific antibody that specifically binds to human MUC16 and human CD3. In certain embodiments, the formulations contain, in addition to the bispecific antibody, a buffer, a surfactant, and a sugar. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability upon stress and storage.

Abstract: Mask assemblies, breathing circuits and related components include configurations for reducing condensation within the mask and/or inhibiting or preventing condensation from coming into contact with a user of the mask. The mask assemblies can incorporate heating elements (such as heating coils), insulating spaces or barrier layers.

Abstract: Embodiments provide for methods of predicting glycation percentage of an amino acid in a therapeutic biomolecule. In one example, a method of predicting a glycation percentage of an amino acid in a biomolecule includes determining a first set of rates for a de-glycation reaction for a first set of temperatures, inferring a second set of one or more rate(s) for the de-glycation reaction for a second set of temperatures, and using the second set of one or more rate(s) to predict the glycation percentage at any temperature corresponding to the second set of temperatures and over any time duration. Also provided are methods for maintaining a glycation percentage of an amino acid within a predetermined glycation percentage range over a shelf-life of a therapeutic biomolecule, and methods for either reducing or increasing a potency of a therapeutic biomolecule in a subject at a time of administration.

Abstract: This invention provides for a component forming a part of a breathing tube, or forming the breathing tube, for example as a part of a breathing circuit for respiratory therapy. The component comprising a tubular body having a foamed wall. The foamed wall can be formed from extrusion of a single extrudate. The foamed wall is of a sufficient minimum optical transparency such that, in use, there is enabled the visual detection of a liquid (or condensate that may have formed) within the tubular body.

Abstract: Condensation or “rain-out” is a problem in breathing circuits and especially neonatal breathing circuits. The subject patent provides an improved breathing tube component for managing rain-out particularly in neonatal applications. In particular the breathing tube has a smooth inner bore, and an outer insulating layer containing stagnant gas and a heater wire.

Abstract: Methods and systems for customizing hides are provided. In particular, one or more embodiments comprise a tanning control system that improves profitability and customer satisfaction by facilitating the customization of hides according to customer orders. Furthermore, one or more embodiments enable the tanning control system to improve efficiency and responsiveness by producing packages of hides that exactly match customer orders. Additionally, one or more embodiments enhance the traceability of hides by capturing data related to the customization of hides.

Abstract: Methods and systems for sorting hides are provided. In particular, one or more embodiments comprise a tanning control system that enhances the traceability of hides by capturing and utilizing data related to the unloading, tanning, sorting, and packaging of hides. Furthermore, one or more embodiments enable the tanning control system to improve efficiency by sorting hides based, at least in part, on data generated during prior tanning processes. Additionally, one or more embodiments facilitate the tanning control system in customizing the sorting and packaging of hides based, at least in part, on one or more hide characteristics and/or customer specifications.

Abstract: The present invention provides novel pharmaceutical formulations comprising an antibody that specifically binds to human Activin A. The formulations may contain, in addition to an anti-Activin A antibody, a histidine buffer, an organic cosolvent, and a thermal stabilizer. The pharmaceutical formulations of the present invention exhibit a surprising degree of antibody stability after storage for several months and after being subjected to thermal and other physical stress.

Abstract: A patient ventilating (23) and aspirating system (8) is disclosed that has a suction tube (9) and connector (6) for connecting to a catheter mount that has a sealed passageway (15) The catheter mount passageway (15) is sealed with an elastomeric seal (16) including a perforation or slit (17). A connector (12) with a piercing member is associated with the suction tube (9). When the connector is attached to the catheter mount the piercing member (20) pierces the seal (16) such that the suction tube (9) can pass through the connector (6) and catheter mount.

Abstract: Ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided suitable for intravitreal administration to the eye. The ophthalmic formulations include a stable liquid formulation and a lyophilizable formulation. Preferably, the protein antagonist has an amino acid sequence of SEQ ID NO:4.