A data management system for a biological process, comprising: a. a single-use component, b. a tag assembly, including a non-volatile memory storage component, that is associated with the single-use component, c. the memory storage component including a unique identification and a memory, and at least one data element that describes a key performance, calibration or control parameter of the single-use component d. a memory reader useable to obtain the identification from the memory storage component.

Nasal pharmaceutical formulations comprising a drug substance having a specific particle size distribution profile are disclosed herein. Such profile provides increased bioavailability, increased efficacy or prolonged therapeutic effect of the drug substance when administered intranasally. The formulations of the present invention may comprise one or more corticosteroids having a specific particle size distribution profile. In a preferred embodiment, the corticosteroid is fluticasone or a pharmaceutically acceptable derivative thereof for the treatment of one or more symptoms of rhinitis. Preferably, the drug substance is fluticasone propionate. The formulations herein may be provided as an aqueous suspension suitable for inhalation via the intranasal route.

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.

The present invention relates to a method for sterilizing a bone graft material, and more specifically, to a method for sterilizing a bone graft material containing sodium carboxymethyl cellulose (CMC) gel without changing its properties.

The present application provides a vascular bioprosthetic graft having an internal diameter of about 3 mm for performing coronary artery bypass grafting surgery. The present application also provides a method for manufacturing the vascular bioprosthetic graft. The vascular bioprosthetic graft is obtained from a xenogeneic venous vessel from the rectum, such as a xenogeneic cranio-rectal vein.

The invention relates to a biocompatible molded part for supporting new bone formation, in particular the reformation of a jaw bone or a jaw bone portion in a mammal, preferably a human, wherein the molded part is suitable to be placed on the jaw bone and is designed as a solid body. The invention also relates to a composition for producing a biocompatible molded part, a method for producing a biocompatible molded part, a use of a biocompatible molded part and a kit comprising a plurality of molded parts.

A sterilised platelet lysate obtained with a method for sterilising a platelet lysate in the liquid state comprising at least the endogenous growth factors TGF-beta 1, EGF, PDGF-AB, IGF-1, VEGF and bFGF. The method comprising freezing the liquid platelet lysate in order to obtain a frozen platelet lysate, and irradiating the frozen platelet lysate with ionising radiation in order to obtain a sterilised platelet lysate, the irradiation being adapted so as to preserve at least 80% of the concentration of at least one of the endogenous growth factors chosen from the group consisting of TGF-beta 1, EGF, PDGF-AB, IGF-1 and VEGF.

Disclosed herein are methods of terminally sterilizing bacterial minicells or compositions comprising bacterial minicells by exposure to ionizing irradiation. Also disclosed are terminally sterilized bacterial minicells, pharmaceutical compositions comprising the bacterial minicells, and methods of using the bacterial minicells and pharmaceutical compositions.

The present invention relates to a wound healing PVA sponge dressing using negative capillary pressure of the dressing material together with auxiliary negative pressure for wound treatment. The PVA sponge dressing is pretreated with gram positive and gram negative biocidal 5 dyes for insertion into or over a wound. A negative pressure pump is mounted to the PVA sponge dressing to produce additional capillary pressure for withdrawing fluid or water vapor from the sponge dressing and a cover is mounted over the sponge material and negative pressure pump forming a unitary sealed package for placement over a wound.

Stable formulations for a dimeric naphthalimide coating and preparation methods for forming said coating, dimeric naphthalimide coated articles, as well as sterilization and storage-stable packaging thereof.