Abstract: The techniques disclosed herein provide a secure control plane (SCP), which in turn provides an isolated secure execution environment for a data plane (DP). Any arbitrary business logic can execute within the DP, and all sensitive data traversing the SCP and entering the DP is encrypted. Split keys generated outside the DP are assembled within, and only within, the DP, where they are used to decrypt sensitive data, enabling the business logic to perform computations using the sensitive data within the secure execution environment. The DP also provides attestation for the business logic executing within the DP, enabling outside parties to verify that the deployed business logic matches published logic. In the event of proprietary logic that is not published, techniques are also disclosed herein that enable verification that proprietary business logic deployed on the DP adheres to security policies.

Abstract: The techniques disclosed herein provide a secure control plane (SCP), which in turn provides an isolated secure execution environment for a data plane (DP). Any arbitrary business logic can execute within the DP, and all sensitive data traversing the SCP and entering the DP is encrypted. Split keys generated outside the DP are assembled within, and only within, the DP, where they are used to decrypt sensitive data, enabling the business logic to perform computations using the sensitive data within the secure execution environment. The DP also provides attestation for the business logic executing within the DP, enabling outside parties to verify that the deployed business logic matches published logic. In the event of proprietary logic that is not published, techniques are also disclosed herein that enable verification that proprietary business logic deployed on the DP adheres to security policies.

Abstract: Biopharmaceutical compositions and drug products disclosed herein exhibit reduced amounts of subvisible particle formation. Compositions and drug products disclosed herein comprise a protein and a surfactant or stabilizer including high percentage amounts (e.g., at least 97%) of a long-chain fatty acid ester. Also disclosed herein are methods of preparing and storing such compositions and drug products.

Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.

Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.

Abstract: Biopharmaceutical compositions and drug products disclosed herein exhibit reduced amounts of subvisible particle formation. Compositions and drug products disclosed herein comprise a protein and a surfactant or stabilizer including high percentage amounts of a long-chain fatty acid ester. Also disclosed herein are methods of preparing and storing such compositions and drug products.

Abstract: The techniques disclosed herein provide a secure control plane (SCP), which in turn provides an isolated secure execution environment for a data plane (DP). Any arbitrary business logic can execute within the DP, and all sensitive data traversing the SCP and entering the DP is encrypted. Split keys generated outside the DP are assembled within, and only within, the DP, where they are used to decrypt sensitive data, enabling the business logic to perform computations using the sensitive data within the secure execution environment. The DP also provides attestation for the business logic executing within the DP, enabling outside parties to verify that the deployed business logic matches published logic. In the event of proprietary logic that is not published, techniques are also disclosed herein that enable verification that proprietary business logic deployed on the DP adheres to security policies.

Abstract: Biopharmaceutical compositions and drug products disclosed herein exhibit reduced amounts of subvisible particle formation. Compositions and drug products disclosed herein comprise a protein and a surfactant or stabilizer including high percentage amounts (e.g., at least 97%) of a long-chain fatty acid ester. Also disclosed herein are methods of preparing and storing such compositions and drug products.

Abstract: The present disclosure includes high concentration, low viscosity pharmaceutical formulations that include an anti-C5 antibody or antigen-binding fragment thereof and arginine. Such formulations may be provided in association with an RNAi molecule such as cemdisiran. Methods of treating C5-associated diseases such as PNH and aHUS are also provided.

Abstract: An apparatus is provided which comprises: a chassis compartment having a bottom surface and walls orthogonal to the bottom, wherein the chassis compartment comprises: a rectangular opening, which may be designed to accept a microelectromechanical (MEMS) device and four slots, which may be designed to accept one or more magnet(s), extending outwardly from the rectangular opening, wherein each of the slots comprises: an inner opening having a length coextensive with a side of the rectangular opening, and an outer opening having corresponding ends that extend a length of the outer opening beyond the length of the inner opening. Other embodiments are also disclosed and claimed.

Abstract: Biopharmaceutical compositions and drug products disclosed herein exhibit reduced amounts of subvisible particle formation. Compositions and drug products disclosed herein comprise a protein and a surfactant or stabilizer including high percentage amounts (e.g., at least 97%) of a long-chain fatty acid ester. Also disclosed herein are methods of preparing and storing such compositions and drug products.

Abstract: An apparatus is provided which comprises: a chassis compartment having a bottom surface and walls orthogonal to the bottom, wherein the chassis compartment comprises: a rectangular opening, which may be designed to accept a microelectromechanical (MEMS) device and four slots, which may be designed to accept one or more magnet(s), extending outwardly from the rectangular opening, wherein each of the slots comprises: an inner opening having a length coextensive with a side of the rectangular opening, and an outer opening having corresponding ends that extend a length of the outer opening beyond the length of the inner opening. Other embodiments are also disclosed and claimed.

Abstract: A device and method are described for the delivery of cells, tissues, enzymes and/or pharmacological agents for the treatment or prevention of diseases, disorders or deficiencies. The device is placed intravascularly and includes a chamber that houses living cells delimited by a membrane on either side that physically separates the cells from the blood stream and the central lumen of the catheter. The device can be inserted over a guidewire and permits flushing and reloading of the central lumen with viability supporting factors that sustain the cells in the outer chamber for long indwelling times without removing it from the body. In addition, the central lumen can be used to deliver therapeutic substances or withdraw blood.