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Methods for reducing pathogens in biological samples

A technology of biological samples and pathogens, applied in the direction of pharmaceutical devices, types of packaging items, packaged food, etc., can solve the problems of reducing the utilization rate of blood components, difficulty, and negative effects of licensing

Active Publication Date: 2008-09-03
泰尔茂比司特生物技术有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because of the limited supply of donated blood from donors, handling contaminated blood significantly reduces the availability of blood components needed for critical therapeutic management
Third, current screening methods are limited to approximately nine pathogen-specific assays
These unwanted photochemical processes are also difficult to characterize as a function of exposure time and can seriously undermine efforts to quantify the amount of radiation actually delivered to a sample during a particular treatment regimen.
Variations in the transmission properties of biological sample containers during pathogen reduction processing can obscure the precise determination of the degree of pathogen reduction achieved, undermine quality control efforts, and can negatively impact product validation and regulatory approvals
Second, many conventional containers for biological samples, such as polyolefin bags, are at least partially permeable to high-energy ultraviolet electromagnetic radiation, thereby reducing the viability and biological activity of healthy cells, tissues, and biomolecules, such as proteins

Method used

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  • Methods for reducing pathogens in biological samples
  • Methods for reducing pathogens in biological samples
  • Methods for reducing pathogens in biological samples

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Example 1 : Platelet Viability Studies Using the Pathogen Reduction Methods of the Invention

[0087] background:

[0088] Changes in several in vitro platelet quality parameters during platelet storage correlated with decreased platelet viability in vivo, as measured by radiolabeled post-transfusion platelet recovery and viability. The purpose of this study was to focus on identifying the correlation of in vitro parameters with the rate of platelet recovery in vivo. We then validated the predictiveness of in vitro cell mass measurements using the in vivo recovery rate of platelets treated with a pathogen reduction method using riboflavin and light.

[0089] Research Design and Methods:

[0090] Two platelet recovery clinical studies using radiolabeled platelets were conducted with regulatory review and approval. In the first study, using in vivo platelet recovery rates, the correlation of in vitro cell quality parameters was established using 18 platelet product...

Embodiment 2

[0151] Example 2: Citrate-plasticized poly(vinyl chloride) containers pass through after exposure to ultraviolet light permeability

[0152] 1 Introduction

[0153] Characterization of citrate-plasticized poly(vinyl chloride) containers before and after exposure to electromagnetic radiation in O 2 and CO 2 Aspects of permeability in order to verify their usefulness in the method of the invention. An object of the present invention is to provide 2 and CO 2A container that exhibits a permeability that does not decrease significantly upon exposure to electromagnetic radiation having the wavelength, radiant energy, and radiant power used to process blood and blood components. Furthermore, it is an object of the present invention to provide a multifunctional container for storing blood and blood components and for treating blood and blood components with electromagnetic radiation, avoiding unnecessary and resource-intensive additional sample transfer steps.

[0154] For pl...

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Abstract

This invention provides methods, devices and device components for treating biological samples with electromagnetic radiation. The methods, devices and device components of the present invention are capable of providing well characterized, uniform and reproducible net radiant energies and / or radiant powers to biological samples undergoing processing. In addition, the present methods, devices and device components are capable of delivering electromagnetic radiation to biological samples having a distribution of wavelengths selected to provide enhanced pathogen reduction, while minimizing photoinduced damage to components comprising therapeutic and / or reinfusion agents.

Description

[0001] Cross References to Related Applications [0002] This application claims priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application US 60 / 696,932, filed July 6, 2005, which application is hereby incorporated by reference in its entirety to the extent not disclosed herein The content is contradictory. Background of the invention [0003] The collection, processing and purification of biological samples are important processes in a range of medical therapies and procedures. Important biological samples for use as therapeutic agents include whole blood and purified blood components such as red blood cells, platelets, white blood cells and plasma. In the field of transfusion medicine, one or more whole blood components are introduced directly into a patient's bloodstream to replace depleted or missing components. Infusion of plasma-derived substances, such as blood proteins, also plays a key role in many therapeutic applications. For example, plasma-derived ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/00A61L2/08A61L2/10A61J1/00
CPCA61L2/0011A61L2/0082A61L2/0088A61M1/3681A61M2205/053A61M1/3683
Inventor R·P·古德里奇C·A·斯科特
Owner 泰尔茂比司特生物技术有限责任公司