Analytical QbD method development for a CZE method for quantifying virus particles

Cari Sänger - van de Griend

Analytical QbD method development for a CZE method for quantifying virus particles

Cari Sänger - van de Griend^*

^*Corresponding author for this work

Research output: Web publication or Non-textual form › Web publication or Website › Professional

Abstract

An analytical quality by design (AQbD) approach was embraced for the development of a capillary zone electrophoresis (CZE) method for the quantification of intact virus particles. With CE, the intact adenovirus particles were separated from sample matrix components such as cell debris, residual cell DNA, proteins, and salts. The intact adenovirus particle concentrations obtained by CE were overall equivalent to those obtained by quantitative polymerase chain reaction (qPCR), although the CE method showed better precision (RSD < 6%) than anion-exchange HPLC and qPCR (10 – 25% RSD). In this webcast, we will present the method, and discuss conclusions, including: Analysis times were much shorter with CE than with qPCR, allowing analysis of 30 samples in less than 4 h CE proved highly useful for process development support and as a result has been implemented for in-process control testing for adenovirus vaccine manufacturing

Original language	English
Media of output	Online
Size	webinar
Publication status	Published - 16 Apr 2018
Externally published	Yes

Keywords

CE
viral vaccine analysis
AQbD
CZE

Access to Document

https://go.technologynetworks.com/analytical-qbd-method-development-for-a-cze-method-for-quantifying-virus-particlesLicence: Unspecified

Handle.net

Persistent link

Cite this

@misc{b4cce41d18c94782b3052c6f7431d5f6,

title = "Analytical QbD method development for a CZE method for quantifying virus particles",

abstract = "An analytical quality by design (AQbD) approach was embraced for the development of a capillary zone electrophoresis (CZE) method for the quantification of intact virus particles. With CE, the intact adenovirus particles were separated from sample matrix components such as cell debris, residual cell DNA, proteins, and salts. The intact adenovirus particle concentrations obtained by CE were overall equivalent to those obtained by quantitative polymerase chain reaction (qPCR), although the CE method showed better precision (RSD < 6%) than anion-exchange HPLC and qPCR (10 – 25% RSD). In this webcast, we will present the method, and discuss conclusions, including: Analysis times were much shorter with CE than with qPCR, allowing analysis of 30 samples in less than 4 h CE proved highly useful for process development support and as a result has been implemented for in-process control testing for adenovirus vaccine manufacturing ",

keywords = "CE, viral vaccine analysis, AQbD, CZE",

author = "{S{\"a}nger - van de Griend}, Cari",

year = "2018",

month = apr,

day = "16",

language = "English",

}

TY - ADVS

T1 - Analytical QbD method development for a CZE method for quantifying virus particles

AU - Sänger - van de Griend, Cari

PY - 2018/4/16

Y1 - 2018/4/16

N2 - An analytical quality by design (AQbD) approach was embraced for the development of a capillary zone electrophoresis (CZE) method for the quantification of intact virus particles. With CE, the intact adenovirus particles were separated from sample matrix components such as cell debris, residual cell DNA, proteins, and salts. The intact adenovirus particle concentrations obtained by CE were overall equivalent to those obtained by quantitative polymerase chain reaction (qPCR), although the CE method showed better precision (RSD < 6%) than anion-exchange HPLC and qPCR (10 – 25% RSD). In this webcast, we will present the method, and discuss conclusions, including: Analysis times were much shorter with CE than with qPCR, allowing analysis of 30 samples in less than 4 h CE proved highly useful for process development support and as a result has been implemented for in-process control testing for adenovirus vaccine manufacturing

AB - An analytical quality by design (AQbD) approach was embraced for the development of a capillary zone electrophoresis (CZE) method for the quantification of intact virus particles. With CE, the intact adenovirus particles were separated from sample matrix components such as cell debris, residual cell DNA, proteins, and salts. The intact adenovirus particle concentrations obtained by CE were overall equivalent to those obtained by quantitative polymerase chain reaction (qPCR), although the CE method showed better precision (RSD < 6%) than anion-exchange HPLC and qPCR (10 – 25% RSD). In this webcast, we will present the method, and discuss conclusions, including: Analysis times were much shorter with CE than with qPCR, allowing analysis of 30 samples in less than 4 h CE proved highly useful for process development support and as a result has been implemented for in-process control testing for adenovirus vaccine manufacturing

KW - CE

KW - viral vaccine analysis

KW - AQbD

KW - CZE

M3 - Web publication or Website

ER -

Analytical QbD method development for a CZE method for quantifying virus particles

Abstract

Keywords

Access to Document

Handle.net

Fingerprint

Cite this