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Validation of On-line Total Organic Carbon Analysers for Release Testing Using ICH Q2

This paper discusses how characteristics for consideration during the validation of analytical procedures may be applied to on-line Total Organic Carbon (TOC) analysers to enable them to be used to provide release test data for Water for Injection (WFI) and Purified Water (PW).

GMPクリーンルームの清浄度クラスと日常環境モニタリング

AUC Insights - Analysis of Protein-Protein-Interactions by Analytical Ultracentrifugation

Protein-Protein-Interactions (PPI) are fundamental to the function of proteins and the life of a cell. PPIs can be divided into homo- or heterocomplexes whether being present as dimers or multimers

Hydraulic Particle Counter Sample Preparation

Best Practices for repeatable particle count results

AUC Insights - Sample concentration in the Analytical Ultracentrifuge AUC and the relevance of AUC data for the mass of complexes, aggregation content and association constants

Sample concentration in the Analytical Ultracentrifuge AUC and the relevance of AUC data for the mass of complexes, aggregation content and association constants

AUC Insights - Assessing the quality of adeno-associated virus gene therapy vectors by sedimentation velocity analysis

Since the first gene therapy study in the late 1980s, there has been an ongoing interest in gene therapy strategies.

Multi-Wavelength Analytical Ultracentrifugation of Human Serum Albumin complexed with Porphyrin

ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems

This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document2 from the International Conference on Harmonisation.

Principi di sicurezza BeckmanConnect

Questo documento evidenzia le funzioni relative alla privacy ed alla sicurezza della soluzione di gestione remota BeckmanConnect

Points importants concernant la sécurité de BeckmanConnect

Le présent document souligne les critères de confidentialité et de sécurité de la solution de gestion à distance BeckmanConnect

BeckmanConnect Security Highlights

This document highlights the privacy and security features in the BeckmanConnect remote management solution.

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BeckmanConnect Security Highlights

This document highlights the privacy and security features in the BeckmanConnect remote management solution

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The Basics and Vision of Exosome Research

Authors: Dr. Takahiro Ochiya and Dr. Yusuke Yoshioka | Published 2016

Exosome Subclass Analysis

Authors: Dr. Kiyotaka Shiba, Dr. Satoshi Yamamoto and Dr. Kazuya Iwai | Tokyo Japan

21 CFR Part 11 Data Integrity for On-line WFI Instruments

This whitepaper takes a look at how quality-critical on-line Total Organic Carbon (TOC) and conductivity instrumentation for WFI (water for injection) quality control can be configured to help companies comply with the FDA’s expectations on data integrity, including the use of Microsoft Active Directory and PDF data export.

Absolute Counting using the CytoFLEX

In this whitepaper we compare and contrast syringe-based and peristaltic pump-based fluidics system for the application of beadless absolute counting. Topics important to the validation of a counting assay are discussed.

Inactivation of COVID-19 disease virus SARS-CoV-2 with Beckman Coulter viral RNA extraction lysis buffers

White Paper: We conducted experiments to assess the virus inactivation status after treatment with lysis buffer (LBF) from RNAdvance Viral or RNAdvance Viral XP extraction kits.

Validating On line TOC Analysers for Product Release using ICH Q2

Whitepaper by Author Tony Harrison is a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017

ClearLLab 10C Panel Markers and how they are combined - Whitepaper

Utility of the ClearLLab 10C panel as an aid in the differential diagnosis of hematologically abnormal patients having or suspected of having certain hematopoietic neoplasms

Standardized Compensation Setup for the ClearLLab 10C Application - Whitepaper

Robustness and utility of the ClearLLab Compensation Kit and ClearLLab Compensation Beads

Tare Volume recommendations for HIAC Systems using HRLD Sensors

Selecting the appropriate Tare Volume for your application is one of the most critical elements for producing accurate, repeatable, and reproducible results.

Gain Independent Compensation Feature of CytExpert for CytoFLEX Software

Demonstrates the feature of Gain Independent Compensation using a multicolor immunophenotyping panel

21CFR part 11 Data Integrity for On-line WFI Instruments

Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017

Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring

Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017

Importance of TOC measurement in WFI in light of European Pharmacopoeia EP 2.2.44 change

Whitepaper by Author Tony Harrison is a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017

Characterization of the Beckman Coulter's RNAdvance Viral XP RNA Extraction Kit using AccuPlex™ SARS–CoV–2 Reference Material Kit

White Paper: iRepertoire performed analytical performance assays and specimen assays to demonstrate that the RNAdvance Viral XP extraction kit has a limit of detection of RNA (LoD) of 1 copy of RNA, specifically tested with AccuPlex™ SARS–CoV–2 Reference Material Kit, per microliter of sample.

Liquid Biopsy Cancer Biomarkers – Current Status, Future Directions

White Paper: We will discuss the current state of liquid biopsy, with a particular focus on cancer genomics. We also discuss some of the keys to success in working with cell-free DNA (cfDNA), and we will finish with future directions of this exciting field.

ClearLLab Control Cells - A Process Control for ClearLLab 10C Application - Whitepaper

ClearLLab Control Cells, a liquid preparation of stabilized human erythrocytes and leukocytes (lymphocytes, monocytes and granulocytes).

SPRIselect User Guide

SPRI Based Size Selection

Whitepaper: Support for Compliance with 21 CFR Part 11 Electronic Records: CytoFLEX Flow Cytometers with CytExpert 2.3 Software

Provides a table referencing the regulation along with the specific software features that facilitate compliance with that section of the law

Offline Flow Cytometry Analysis Software: Importance of Scaling and Data Visualization

Learn about the flow cytometry open platform data structure and how it facilitates for robust offline analysis

Comparing DxFLEX and FC500 Flow Cytometer Instrument Performance - Whitepaper

Discover the improved performance of the DxFLEX flow cytometer compared to the FC500 in a clinical study using the DuraClone B27 kit.

Quality Control Electronic Records for 21 CFR part 11 Compliance

This paper describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.

Whitepaper: Kaluza Analysis Tree Plots offer a fast and comprehensive overview of multi-color flow cytometry data

Introduces the Tree Plot as a supervised approach for comprehensive deconvolution of flow cytometry data, bridging the gap between manual gating and unsupervised computational analysis

European Pharmacopoeia EP 2.2.44 and Total Organic Carbon

Whitepaper by Author Tony Harrison is a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017

Specifying Non-Viable Particle Monitoring for Aseptic Processing

This paper details key considerations when implementing a continuous non-viable particle monitoring (NVP) system.

Whitepaper: Standardizing multi-color flow cytometry applications with DURAClone reagents

A whitepaper discussing DURAClone reagents are a robust solution for standardizing multi-color flow cytometry applications

Whitepaper: Long Term Stabilization of Tandem Dyes for Use in High Complexity, Multi Variant Flow Cytometry

A whitepaper discussing long-term stabilization of tandem dyes for use in high-complexity, multi-variant flow cytometry

Whitepaper: DuraClone improves standardization of compensation workflow for high-content multicolor applications by flow cytometry

A whitepaper discussing how DuraClone improves standardization of compensation workflow for high-content multicolor applications by flow cytometry

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AUC INSIGHTS_Accessing the quality of AAV_Mar2020

Comparison of Dako’s and Beckman Coulter’s anti-Kappa and Lambda light chains antibodies with protocols including 1, 2 or 3 washing steps of the sample

Performance comparison of Beckman Coulter's new goat polyclonal anti kappa and lambda light chains antibodies against Dako’s gold standard and the importance of washing steps when assessing Kappa and Lambda light chains expression.

Avoid the Pitfalls when Automating Cell Viability Counting for Biopharmaceutical Quality Control

In this paper we show one example of how identifying viable cells by minimum diameter alone can introduce variability of circa 33% in the reported cell concentration. This paper describes how to avoid these common pitfalls when user is adopting a new automated method of cell counting.

The Camelid-Derived VHH-Antibody (Nanobody) JK36 Circumvents the Epitope Overlapping with ADCC-Inducing CD38 Antibodies that is Common To Commercially Available Analytical Mouse Antibodies

Obtain information on the unique properties of camelid antibodies and derived nanobodies such as JK36

Flow Cytometric Analysis of Endothelial Progenitor Cells

Authors: Dorota Sadowicz, Vasilis Toxavidis, John Tigges | Beth Israel Deaconess Medical Center | Harvard Stem Cell Institute

Long Term Stabilization of Tandem Dyes for Use in High Content, Multi Variant Flow Cytometry

Authors: Snehita Sattiraju, Tewfik Miloud, Neha Girish, Murthy Pendyala, Sridhar Ramanathan | Beckman Coulter India Pvt Limited, Bangalore Development Centre, Bangalore, INDIA and Beckman Coulter Life Sciences, Immunotech, Marseille, FRANCE

Major Swiss Medical Research Center Increases Cell Sorting Capability

The Geneva Medical College has doubled its activities since 2010, and has an increasing number of reseachers

Comparing the AQUIOS CL PLG Application to the FC500 MCL FlowCARE PLG Application

The performance of the AQUIOS PLG System (or application) was assessed by comparing the results to the comparator estimation of difference as described in CLSI EP9-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline, Third Edition.

High Content DuraClone Reagents on the CytoFLEX Flow Cytometer: Instrument Setup using the CytoFLEX Compensation Library

Authors: Dr. Nicole Weit, Dr. Andreas Böhmler, Dr. Michael Kapinsky | Published 2015

DuraClone Improves Standardization of Compensation Workflow for High Content Multicolor Applications by Flow Cytometry

Multiparametric flow cytometry is a valuable tool for clinical research as it allows the use of multiple dyes, including tandems, to monitor several markers simultaneously

Detection of Both Surface Proteins and Intracellular Phospho-Determinants in Whole Blood Using the PerFix-p Reagent System

Authors: William L. Godfrey, Li Yang, Samantha Bauchiero, James W. Tung, Valerie Mallet, Lidice Lopez, Vincent Shankey, Emmanuel Gautherot

Room Temperature Stable Unitized Reagents for High Content, High Throughput Flow Cytometry Applications

Authors: Neha Girish, Jean-Marc R Busnel, Samee Saif, Nathalie Dupas, Tewfik Miloud,Vishakha Mangale, Emmaunel Gautherot, Sridhar Ramanathan

Hydraulic Particle Counter Sample Preparation

The number one contributor to an inaccurate Particle Counter sampling result is improper sample preparation

ROC - Remote Online Counter Basic Setup Requirements

The new ROC (Remote Online Counter) is the direct replacement for the PM4000 series instruments

Designing “Backbone” Multi-Color Panels for T-cell and Treg Populations with Allowance for Drop-In Reagents

Authors: William L. Godfrey, Jonel G. Lawson, Carlos A. Garcia, Enrique Rabellino, Jeffrey R. Cobb, and James W. Tung

Comparison of the Analysis Capabilities of Beckman Coulter MoFlo XDP™ and Becton Dickinson FACSAria™ I and II

Authors: Dr. Carley Ross, Angela Vandergaw, Katherine Carr and Karen Helm

Use of Precision Profiles to Estimate Precision of Lymphocyte Subset Analysis by Flow Cytometry

Authors: Robert Magari, Diana, B. Careaga, Karen, K. Lo, Xiangyang Dong, Elena Afonina, Liliana, M. Tejidor

Offline Flow Cytometry Analysis Software: Importance of Scaling and Data Visualization

This whitepaper discussed the flow cytometry open platform data structure and how it facilitates for robust offline analysis, the importance of data scaling and display features in ensuring your data looks consistent with the native environment, and illustrates specific examples comparing the native display to an offline data analysis software across a variety of platforms and manufacturers.

Comparison of Sorting Capabilities of Beckman Coulter MoFlo™ XDP and Becton Dickinson FACSAria™ I and II

Authors: Dr. Carley Ross, Angela Vandergaw, Katherine Carr and Karen Helm

Demonstration of the Analytical Performance of the Navios Flow Cytometer in a Multi-Center Study

Authors: Diana Careaga, Robert Magari, Karen Lo, Michael Keeney, Janice Popma, Joanne Luider, Aito Ueno, Gerard Lozanski, Bruce Briggs, Elena Afonina, Enrique Rabellino and Liliana Tejidor

Hematopoietic Bone Marrow Cell Sorting Without Compromise: 7 Lasers, Eight Colors, Six Way Sorting A Novel Approach

Authors: Vasilis Toxavidis, John Tigges & Meritxell Alberich Jorda

Enumeration of T, B, and NK Subpopulations in Aged Whole Blood Samples using the Aquios CL Instrument with Tetra Application

Authors: Violetta Headley, Xiangyang Dong, Raquel Cabana, Veronica Trujillo, Michael Thomas, Robert Magari and Elena Afonina

Evaluation of the Analytical Performance of the Aquios CL Flow Cytometer in a Multi-Center Study

A multi-center study was conducted to establish the performance of the AQUIOS CL Flow Cytometer with AQUIOS Tetra Panel reagents for lymphocyte subset analysis

CytoFLEX System Performance Evaluation

Performance testing of cytometry instruments is utilized to characterize the capability of the cytometer to perform high complexity applications

Epithelial Cell Death Analysis of Cell Cycle by Flow Cytometry

Authors: Savithri Balasubramanian, John Tigges, Vasilis Toxavidis and Heidi Mariani

Comparing the Aquios CL Flow Cytometer, the Facscalibur Flow Cytometer and the Unicel DXH 800 Hematology Analyzer Tetra Applications

The comparability of the AQUIOS Tetra System was assessed by comparing the results with the predicate method using the estimation of difference as described in CLSI EP9-A3 Method Comparison and Bias Estimation

Comparison of Aquios Tetra and Navios Tetra System Performance

Authors: Violetta Headley, Michael Keeney, Dominika Benjamins, Justin Rohrbach, Robert Ortega, Karen Lo, Liliana Tejidor and Elena Afonina

Root cause investigation for pharmaceutical water systems

In this whitepaper we discuss some typical sources of contamination in water systems and how root-cause investigations can be supported using on-line Total Organic Carbon (TOC) analysers.