Baxter International Inc.

Baxter Healthcare Sa

Baxalta Gmbh

Nektar Therapeutics

Heinz Anderle

Peter Turecek

Hans-Peter Schwarz

Daniel R Boggs

Peter Matthiessen

Thomas R Kreil

Alfred Weber

Zhihao Fang

Mary J Bossard

Ping Zhang

Hanspeter Rottensteiner

Sean M Culbertson

Katalin Varadi

Harold Zappe

Andrea Engelmaier

Gerald Schrenk

The invention relates to the development of in vitro assay systems that force the release of a water-soluble polymer, such as polyethylene glycol (PEG) and polysialic acid (PSA), from proteins modified with a reversibly-linked water-soluble polymer. The invention includes methods for analyzing the release of the water-soluble polymer and measuring regained protein activity. The invention further includes methods appropriate for the quality control of proteins modified with releasable water-soluble polymers, including polymers like PEG and PSA.

Methods for determining active ingredients in pro-drug PEG protein conjugates with releasable PEG reagents (in vitro de-pegylation)

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.

Method for the validatable inactivation of pathogens in a biological fluid by irradiation

The present invention relates to a method for the determination of polysorbate in a protein-containing sample. The method of the present invention involves the pretreatment of the sample by alkaline hydrolysis followed by colorimetric determination.

Method for the determination of polysorbate 80

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.

Methods for the inactivation of microorganisms in biological fluids, flow through reactors and methods of controlling the light sum dose to effectively inactivate microorganisms in batch reactors

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Klosterneuburg, Austria

Heinz Anderle