A method for collecting a sterilized fluid includes passing a fluid through an inlet stem and into a chamber of a storage container so that the fluid collects within the chamber of the storage container; and applying a beam of radiation to the inlet stem so that the beam of radiation passes through the inlet stem and through at least a portion of the fluid passing through the inlet stem, the beam of radiation at least partially sterilizing the fluid passing through the inlet stem and into the chamber of the storage container.

The present disclosure provides a biodegradable drug delivery composition including a vehicle and an insoluble component comprising beneficial agent dispersed in the vehicle. In some cases, the composition includes sucrose acetate isobutyrate, biodegradable polymer, hydrophobic solvent, and a complex comprising a counterion and beneficial agent, such as protein, peptide, nucleic acid, or small molecular weight compound. Also provided, are kits including the biodegradable drug delivery composition or components thereof, as well as methods of making and using the biodegradable drug delivery composition.

Compositions and methods are disclosed that relate to protecting biological activity of a biologically active molecule, including a biologically active protein or biological response modifier such as an immune response modifier, against radiation damage during radiation sterilization. Inclusion of at least one radio-protectant compound, for example, cysteine, reduced glutathione, melatonin, and/or histidine, in an exemplary mitogenic lectin formulation during spray-drying onto surfaces of immunoassay tubes, surprisingly protected the lectin against loss of biological (mitogenic) activity that would otherwise result from electron beam radiation sterilization. The radioprotectant compound also protected other biologically active molecules and stabilized their biological activities, permitting them to retain biological activity after extended storage following the radiation treatment.

Gamma ray and e-beam irradiation provided efficient sterilization of certain self-assembling peptides (including RADA16 in solution) without substantial degradation of the major peptide, while, e.g., another self-assembly peptide, QLEL12 was significantly degraded following irradiation. Irradiation sterilization enhances the rheological property of, for example, RADA16 hydrogel once applied to tissue at a physiological pH. The rheological property increase can result in higher efficacy in a variety of biomedical applications.

A method of preparing a sterilized heart valve, the method comprising: compressing a compressible frame of a heart valve from an expanded configuration to a crimped configuration; the heart valve comprising the frame and a plurality of leaflets coupled to the frame; wherein each of the plurality of leaflets comprises a dry, unfixed, decellularized, antigen-free biological tissue that has been treated with a solution comprising a polyol or polyhydric alcohol; packaging the heart valve within a sealed packaging system while the heart valve is in the crimped configuration; and sterilizing the heart valve packaged within the sealed packaging system with one or more cycles of electron beam radiation.

The present disclosure is directed to a method of making a composition by combining a vehicle, e.g., a single phase vehicle, and an insoluble component comprising a beneficial agent, and sterilizing the composition using ionizing radiation prior to use, wherein the beneficial agent is stable following exposure to a sterilizing dose of ionizing radiation. Related compositions and methods are provided.

Methods and Apparatus are provided for irradiating a liquid with accelerated electrons. The liquid is prepared. The liquid is mixed with particles having at least one luminescent substance, where the particles are formed such that the particles are dispersed in the liquid after mixing. The liquid is irradiated with an electromagnetic radiation, which induces the at least one luminescent substance to luminesce. An actual value of a physical quantity characterizing the luminescence of the luminescent substance is detected. The liquid is irradiated with accelerated electrons until the detected actual value corresponds to a target value.

A method for collecting a sterilized fluid includes passing a fluid through an inlet stem and into a chamber of a storage container so that the fluid collects within the chamber of the storage container; and applying a beam of radiation to the inlet stem so that the beam of radiation passes through the inlet stem and through at least a portion of the fluid passing through the inlet stem, the beam of radiation at least partially sterilizing the fluid passing through the inlet stem and into the chamber of the storage container.

The invention provides a unit operation formed by a device and its use for continuous virus inactivation of a continuous flow of a process fluid. The unit operation formed by a device comprises a single inlet at one end and an outlet at the opposite end and at least one HFI, characterized in that the HFI further comprises at least one installation.

The invention discloses a method for virus clearance of a cell culture medium, comprising the steps of: i) providing a bulk medium portion, comprising amino acids and glucose, and a first additive portion, comprising vitamins in aqueous solution; ii) subjecting the bulk medium portion to a high temperature short time treatment (HTST); iii) passing the first additive portion through a virus retentive filter or an ultrafilter; and iv) after steps ii) and iii), mixing the bulk medium portion with the first additive portion to obtain a cell culture medium.