Abstract:
The present invention relates to a method for determining an effective dose of monochromatic or polychromatic light from one or more light sources to inactivate microorganisms present in a biological fluid, preferably a non-transparent fluid. Moreover, there is provided a method for the inactivation of microorganism in a biological fluid in a flow-through-reactor. Moreover, the invention advantageously provides a flow-through-reactor with one or more thermostated light sources. The invention further provides a method of controlling the light sum dose of monochromatic or polychromatic light emitted from one or more light sources to effectively inactivate microorganisms present in a biological fluid in a batch reactor.
Abstract:
Stable pharmaceutical preparations containing blood coagulation Factor VII is disclosed. The pharmaceutical preparations containing blood coagulation Factor VII are free of coagulation inhibitors and are stable over a wide range of environmental conditions. Also provided are blood coagulation Factor VII preparations having a minimum activity of 50 Units/mg of protein that contain less than 5% activated blood coagulation Factor VII (Factor VIIa). The blood coagulation Factor VII containing preparations may also contain other blood coagulation factors and are free from detectable transmissible human pathogens.
Abstract:
A validatable method for determining a photochemically effective dose for inactivating pathogens in a fluid sample is described herein. In particular, the instant invention covers methods for determining a photochemically effective dose sufficient to inactivate pathogens in a biological sample while leaving biologically active substances of interest unaffected. A batch irradiation reactor effective for inactivating pathogens in biological samples is also described.
Abstract:
Methods of preparing alpha-1-antiproteinase inhibitor and controlling the amount of des-lys alpha-1-antiproteinase inhibitor in the preparation, and compositions comprising the same, as well as methods of treatment using the same are provided.
Abstract:
The present invention relates to formulations of ADAMTS13 with enhanced or desirable properties. As such, the invention provides liquid and lyophilized formulations of ADAMTS13 that are suitable for pharmaceutical administration. Among other aspects, the present invention also provides methods of treating various diseases and conditions related to VWF and/or ADAMTS13 dysfunction in a subject. Also provided herein are kits comprising ADAMTS13 formulations useful for the treatment of various diseases and conditions.
Abstract:
The present invention relates to a method for determining the highest temperature that is suitable for performing accelerated protein stability studies, as well as to a method for modeling real-time protein stability from accelerated stability data generated at said temperature.
Abstract:
The present invention relates to formulations of ADAMTS13 with enhanced or desirable properties. As such, the invention provides liquid and lyophilized formulations of ADAMTS13 that are suitable for pharmaceutical administration. Among other aspects, the present invention also provides methods of treating various diseases and conditions related to VWF and/or ADAMTS13 dysfunction in a subject. Also provided herein are kits comprising ADAMTS13 formulations useful for the treatment of various diseases and conditions.
Abstract:
The present invention provides methods of preparing alpha-1-antiproteinase inhibitor and controlling the amount of des-lys alpha-1-antiproteinase inhibitor in the preparation, and compositions comprising the same, as well as methods of treatment using the same.
Abstract:
A validatable method for determining a photochemically effective dose for inactivating pathogens in a fluid sample is described herein. In particular, the instant invention covers methods for determining a photochemically effective dose sufficient to inactivate pathogens in a biological sample while leaving biologically active substances of interest unaffected. A batch irradiation reactor effective for inactivating pathogens in biological samples is also described.
Abstract:
A native, chromatographically purified α1-AT preparation having a purity of at least 0.7 PU/mg protein and a relative plasma α1-AT activity of at least 120% is disclosed. The ratio of active to inactive α1-AT is higher than in plasma.Furthermore, a method of producing this preparation is disclosed, as well as the use of a carrier material, e.g. an inorganic carrier material such as hydroxylapatite for separating active α1-AT from inactive α1-AT.