Regeneration of Capto Core 700 resin through high throughput and laboratory scale studies and impact on production of a SARS-CoV-2 vaccine candidate.

Autor: Konstantinidis S; Vaccine Process Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA., Reinhart SR; Vaccine Process Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA., Castagna C; Vaccine Process Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA., Poplyk MR; Vaccine Process Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA., Rustandi RR; Vaccine Analytical Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA., Flor KL; Investigative Pathology, MRL, Merck & Co., Inc., Rahway, New Jersey, USA., Acevedo-Skrip J; Vaccine Analytical Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA., Thompson R; Vaccine Analytical Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA., Wang CJ; Vaccine Analytical Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA., Wang SC; Vaccine Process Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA., Winters MA; Vaccine Process Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA.
Jazyk: angličtina
Zdroj: Biotechnology journal [Biotechnol J] 2022 Oct; Vol. 17 (10), pp. e2200191. Date of Electronic Publication: 2022 Jul 28.
DOI: 10.1002/biot.202200191
Abstrakt: 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.
(© 2022 The Authors. Biotechnology Journal published by Wiley-VCH GmbH.)
Databáze: MEDLINE
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