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Cell Banks Preparation In Biopharmaceuticals Production

Agnieszka Sobolewska-Ruta
Agnieszka Sobolewska-Ruta
 e 
Piotr Zaleski
Piotr Zaleski
   | 10 giu 2019
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Article Category: article
Pubblicato online: 10 giu 2019
Pagine: 87 - 100
Ricevuto: 01 nov 2018
Accettato: 01 gen 2019
DOI: https://doi.org/10.21307/PM-2019.58.1.087
© 2019 Agnieszka Sobolewska-Ruta et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Fig. 1.

Consecutive stages of production of biopharmaceuticals in prokaryotic system. The stages are presented (stabile system selection, cell bank system, recombinant protein production) with reference to ICH guidelines (The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) adequate on individual production stages. The most important guidelines for establishing the cell bank are gathered in ICH Q5B and ICH Q5D (modified [14]). Master Cell Bank (MCB); Research Cell Bank (RCB); Working Cell Bank (WCB); ICH Q5 (Q5 – quality of biotechnological products) – guidelines referring to quality of biotechnological products manufactured according to Good Manufacturing Procedures; ICH Q5A [26], ICH Q5B [27], ICH Q5D [28], ICH Q5E [29], ICH Q7 [30].
Consecutive stages of production of biopharmaceuticals in prokaryotic system. The stages are presented (stabile system selection, cell bank system, recombinant protein production) with reference to ICH guidelines (The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) adequate on individual production stages. The most important guidelines for establishing the cell bank are gathered in ICH Q5B and ICH Q5D (modified [14]). Master Cell Bank (MCB); Research Cell Bank (RCB); Working Cell Bank (WCB); ICH Q5 (Q5 – quality of biotechnological products) – guidelines referring to quality of biotechnological products manufactured according to Good Manufacturing Procedures; ICH Q5A [26], ICH Q5B [27], ICH Q5D [28], ICH Q5E [29], ICH Q7 [30].

Fig. 2.

The main procedure for bacterial cell bank establishing. The Master Cell Bank (MCB) must be established first, from a single, well-selected bacterial colony obtained after transformation of bacterial strain with expression vector. Subsequently, Working Cell Bank (WCB) must be established from a single vial from MCB. Both Cell Banks must be characterised before admission to subsequent stages of recombinant protein production (determination of features and purity of the strain). The picture was modified, based on [66].
The main procedure for bacterial cell bank establishing. The Master Cell Bank (MCB) must be established first, from a single, well-selected bacterial colony obtained after transformation of bacterial strain with expression vector. Subsequently, Working Cell Bank (WCB) must be established from a single vial from MCB. Both Cell Banks must be characterised before admission to subsequent stages of recombinant protein production (determination of features and purity of the strain). The picture was modified, based on [66].

The characteristic of bacterial cell banks

Test Host train MCB WCB
Identity and purity
Viability + + +
Bacterial strain characteristic + + –
Genotyping/phenotyping + + –
Plasmid presence:
  • plasmid DNA sequencing – + –
  • copy number – + +
  • restriction map – + +
  • the percentage of cells maintaining the plasmid – + +
Adventitious agents
Purity by plating + + +
Presence of bacteriophages + + –

The examples of methods which might be performer in order to characterise bacterial strains for cell bank based on [61]

Method System Manufacturer No. of identified strains (the size of the database)
Phenotypic methods
Biochemical tests API or ID32 bioMerieux, France 822 strains of bacteria and yeast, including 32 newly identified and 67 with new name assigned [2]
BBL Crystal Becton Dickinson, USA > 500 taxons [5]
Biolog Microbial ID Biolog, USA > 2900 species of aerobic and anaerobic bacteria, yeast and fungi [8]
Vitek 2 Compact bioMerieux, France > 553 different taxons [76]
BD Phoenix Becton Dickinson, USA 319 taxons [6]
Analysis of fatty acid methyl esters Sherlock Microbial Identification System (MIDI) MIDI, USA > 2500 species: including 960 environment isolated species, 593 clinical species, 42 actinomycetes species, 31 species of Mycobacterium, 895 species of anaerobic icroorganisms and 216 species of yeast [67]
Proteomic methods
MALDI TOF MALDI Biotyper Bruker Daltonik, Germany > 2750 species, including 471 species of bacteria, 152 species of fungi and 164 Mycobacterium species [46]
Vitek MS BioMerieux, France 1316 species, 217 new species of bacteria (including 40 anaerobic and 55 of fungi) [77]
FTIR Spectroscopy FTIR Biotyper Bruker Daltonik, Germany > 6534 spectrum for yeast, bacteria from genus: Bacillus, Pseudomonas, Enterobacteriaceae, lactic acid bacteria and acetic acid bacteria, Listeria, Bifidobacterium, Clostridium, Micrococcus and gram-positive bacteria and anaerobic bacteria [22]
Genetic methods
Nucleic acid analysis MicroSeq Microbial Identification System Thermo Fisher Scientific, USA > 2300 species of bacteria and 1100 species of fungi [50]
Rybotyping RiboPrinter System DuPont Nutrition and Health, USA > 6900 patterns for microorganism, including 290 genus and 1400 species and serotypes which are key for dairy and pharmaceutical industry [58]
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