Regeneration of Capto Core 700 resin through high throughput and laboratory scale studies and impact on production of a SARS-CoV-2 vaccine candidate.
CIP
Capto Core
RoboColumns
chromatography
high throughput
live virus vaccine
scale-up
Journal
Biotechnology journal
ISSN: 1860-7314
Titre abrégé: Biotechnol J
Pays: Germany
ID NLM: 101265833
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
revised:
03
06
2022
received:
29
04
2022
accepted:
24
06
2022
pubmed:
1
7
2022
medline:
12
10
2022
entrez:
30
6
2022
Statut:
ppublish
Résumé
During the development of a SARS-CoV-2 vaccine candidate, at the height of the COVID-19 pandemic, raw materials shortages, including chromatography resins, necessitated the determination of a cleaning in place (CIP) strategy for a multimodal core-shell resin both rapidly and efficiently. Here, the deployment of high throughput (HT) techniques to screen CIP conditions for cleaning Capto Core 700 resin exposed to clarified cell culture harvest (CCCH) of a SARS-CoV-2 vaccine candidate produced in Vero adherent cell culture are described. The best performing conditions, comprised of 30% n-propanol and ≥0.75 N NaOH, were deployed in cycling experiments, completed with miniature chromatography columns, to demonstrate their effectiveness. The success of the CIP strategy was ultimately verified at the laboratory scale. Here, its impact was assessed across the entire purification process which also included an ultrafiltration/diafiltration step. It is shown that the implementation of the CIP strategy enabled the re-use of the Capto Core 700 resin for up to 10 cycles without any negative impact on the purified product. Hence, the strategic combination of HT and laboratory-scale experiments can lead rapidly to robust CIP procedures, even for a challenging to clean resin, and thus help to overcome supply shortages.
Identifiants
pubmed: 35771570
doi: 10.1002/biot.202200191
pmc: PMC9353343
doi:
Substances chimiques
COVID-19 Vaccines
0
Sodium Hydroxide
55X04QC32I
1-Propanol
96F264O9SV
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e2200191Informations de copyright
© 2022 The Authors. Biotechnology Journal published by Wiley-VCH GmbH.
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