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Shortening the biologics clinical timeline with a novel method for generating stable, high-producing cell pools and clones.
Hall, Chad A; Kravitz, Rachel H; Johnson, Karl F; Sanek, Nicholas A; Maiti, Payel; Ziemba, Keith R; Liu, Jia; Andreev, Dmitri O; Chrostowski, Victoria L; Collins, Ian J; Bleck, Gregory T.
  • Hall CA; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Kravitz RH; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Johnson KF; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Sanek NA; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Maiti P; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Ziemba KR; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Liu J; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Andreev DO; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Chrostowski VL; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Collins IJ; Catalent Pharma Solutions, Somerset, New Jersey, USA.
  • Bleck GT; Catalent Pharma Solutions, Somerset, New Jersey, USA.
Biotechnol Bioeng ; 2022 Dec 29.
Article in English | MEDLINE | ID: covidwho-2172691
ABSTRACT
Reducing drug development timelines is an industry-wide goal to bring medicines to patients in need more quickly. This was exemplified in the coronavirus disease 2019 pandemic where reducing development timelines had a direct impact on the number of lives lost to the disease. The use of drug substances produced using cell pools, as opposed to clones, has the potential to shorten development timelines. Toward this goal, we have developed a novel technology, GPEx® Lightning, that allows for rapid, reproducible, targeted recombination of transgenes into more than 200 Dock sites in the Chinese hamster ovary cell line genome. This allows for rapid production of high-expressing stable cell pools and clones that reach titers of 4-12 g/l in generic fed-batch production. These pools and clones are highly stable in both titer and glycosylation, showing strong similarities in glycosylation profiles.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study Language: English Year: 2022 Document Type: Article Affiliation country: Bit.28323

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study Language: English Year: 2022 Document Type: Article Affiliation country: Bit.28323