Essen Instruments, Inc.

Sartorius Bioanalytical Instruments, Inc.

Intellicyt Corporation

Sartorious Bioanalytical Instruments, Inc.

Michael W Olszowy

Michael A Artinger

Francis Kevin Kohlmeier

Tyler Gates

Jeffrey W Steaffens

Rebecca K Montange

Antje Schickert

A method for evaluating a biological material for unassociated virus-size particles having a particular epitope uses a fluorescent antibody stain specific for binding with the epitope and a fluid sample with the virus-size particles and fluorescent antibody stain is subjected to flow cytometry with identification of fluorescent emission detection events indicative of passage through a flow cell of a flow cytometer of unassociated labeled particles of virus size including such a virus-size particle and fluorescent antibody stain.

Flow cytometry evaluation of biological material for unassociated virus-size particles

Fluorescent viral particles, including viral particles and a fluorescent dye conjugated to the viral particles, are used for viral contaminant removal testing as part of viral clearance evaluation for biological medical product preparation processes. The conjugated fluorescent dye adds only marginally to viral particle size, but provides versatility both for rapid screening of alternative viral removal approaches during process development and for final process validation, as the fluorescent viral particles have fluorescent activity throughout the viral clearance evaluation process, permitting rapid and consistent quantification of initial test solutions, resulting purified solutions, and intermediate solutions of interest at any point during processing under evaluation.

Viral clearance evaluation for biological medical product preparation processes

In flow cytometry evaluation for unassociated virus-size particles stained with multiple fluorogenic dyes, the fluid sample is stained with an aqueous diluted dye formulation including multiple fluorogenic dyes. Preparation of the aqueous diluted dye formulation includes first preparatory processing to prepare a concentrated dye formulation with the fluorogenic dyes provided in a dry powder mixture mixed with and dissolved into a first liquid medium comprising DMSO. After the first preparatory processing, aqueous liquid diluent is added to dilute the first liquid medium and while the fluorogenic dyes remain in solution the liquid medium is converted to an aqueous liquid medium, which may include DMSO as a minor molar component but at a significant concentration. The stained fluid sample may include dissolved disaccharide.

Methods, kits and stain compositions for flow cytometry evaluation of unassociated virus-size particles using multiple fluorogenic dyes

Antibody stain with low fluorophore ratio for staining virus-size particles

Flow cytometry evaluation for virus-size particles with antibody stain having low fluorophore ratio

A method for evaluating a biological material for unassociated virus-size particles having an adenovirus epitope uses a fluorescent antibody stain specific for binding with the epitope and a fluid sample with the virus-size particles and fluorescent antibody stain is subjected to flow cytometry with identification of fluorescent emission detection events indicative of passage through a flow cell of a flow cytometer of unassociated labeled particles of virus size including such a virus-size particle and fluorescent antibody stain.

Flow cytometry evaluation for unassociated virus-size particles having an adenovirus epitope

A method for evaluating a biological material for unassociated virus-like particles virus size having a particular epitope uses a fluorescent antibody stain specific for binding with the epitope and a fluid sample with the virus-size particles and fluorescent antibody stain is subjected to flow cytometry with identification of fluorescent emission detection events indicative of passage through a flow cell of a flow cytometer of unassociated labeled particles of virus size including such a virus-like particle and fluorescent antibody stain.

Evaluating biological material for unassociated virus-like particles

A method for evaluating a biological material for unassociated virus-size particles of exosomes having a particular epitope uses a fluorescent antibody stain specific for binding with the epitope and a fluid sample with the exosomes and fluorescent antibody stain is subjected to flow cytometry with identification of fluorescent emission detection events indicative of passage through a flow cell of a flow cytometer of unassociated labeled particles of virus size including such an exosome and fluorescent antibody stain.

Flow cytometry evaluation of biological material for exosome particles

Flow cytometry evaluation of biological material for unassociated virus particles in presence of unbound flourescent antibody stain

Evaluating biological material for unassociated virus-size particles with influenza virus epitope

A method for evaluating a biological material for unassociated virus-size particles having a particular epitope indicative of an adeno-associated virus viral type or an adenovirus viral type uses a fluorescent antibody stain specific for binding with the epitope and a fluid sample with the virus-size particles and fluorescent antibody stain is subjected to flow cytometry with identification of fluorescent emission detection events indicative of passage through a flow cell of a flow cytometer of unassociated labeled particles of virus size including such a virus-size particle and fluorescent antibody stain.

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Erie, CO, United States of America

Michael W Olszowy