公开(公告)号：US20200217776A1

公开(公告)日：2020-07-09

申请号：US16781382

申请日：2020-02-04

Applicant: Essen Instruments, Inc. d/b/a Essen BioScience, Inc.

Inventor： Michael A. Artinger ,  Francis Kevin Kohlmeier ,  Michael W. Olszowy ,  Tyler Donald Gates

IPC: G01N15/14 ,  G01N21/64 ,  G01N33/569 ,  C12N7/00 ,  G01N15/06 ,  G01N33/58

Abstract: 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.

公开(公告)号：US20210181073A1

公开(公告)日：2021-06-17

申请号：US17263800

申请日：2019-08-01

Applicant: Essen Instruments, Inc. d/b/a/ Essen Bioscience, Inc.

Inventor： Rebecca K. Montange ,  Antje Schickert ,  Jeffrey W. Steaffens ,  Michael W. Olszowy

IPC: G01N1/30 ,  G01N15/14

Abstract: 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.

公开(公告)号：US20220146485A1

公开(公告)日：2022-05-12

申请号：US17096681

申请日：2020-11-12

Applicant: Essen Instruments, Inc. d/b/a Essen Bioscience, Inc.

Inventor： Michael W. Olszowy

IPC: G01N33/15 ,  C12Q1/04 ,  G01N21/64

Abstract: 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.