TABLE 8.2 (Continued)

Listing of analytical methods applied to qualify and quantify viral preparations

Method

Duration

Principle

Necessitate

labeling

Analytical

Range related

to total

particle count

Reproducibility

% CV

REF

Flow virometry

Minutes/

hours

Fluorescent labeling of viral

components

yes

105 – 1012

44% [ 14]

9–31% [ 15]

[ 14],

[ 15]

Tunable resistive pulse

sensing (TRPS)

Charge and size

determination thanks to

coulter effect

no

105 – 1012

6% [ 16]

24–52% [ 17]

[ 16],

[ 17]

Nanoparticle Tracking

Analysis (NTA)

Size measurement thanks to

detection of Brownian

motion induced by particles

fluorescence or light

diffusion

no

107 – 109

14%

[ 18]

Particle

Population

counting

Flow field fractionation

– Multiple angle light

scattering (FFF-

MALLS)

Light scattering

yes

>10 6

2%

[ 13],

[ 19]

Ion-exchange Liquid

Chromatography

(HPLC)

Separation of virus particles

by chromatography on

monolith column thanks to

charge and size

no

108– 1011

6%

[ 3],

[ 20]

Surface plasmon

resonance (SPR)

Measure of the local

refraction variation index

no

>10 6

< 3%

[ 11]

212

Bioprocessing of Viral Vaccines