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Accelerated cell culture process development and characterization for cilgavimab/tixagevimab (AZD7442) for the prevention and treatment of COVID-19.
Handlogten, Michael W; Bosley, Stefanie; Dunn, Sarah; Zhu, Jie; Lee-O'Brien, Allison; Li, Lina; Therres, Jamy; Chakrabarti, Lina; Khanal, Bijay; Mowery, Rachel; Arumugam, Subhashini; Klover, Judith; Taleb, Mohammed; Reier, Jason; Hatton, Diane; Schmelzer, Albert.
  • Handlogten MW; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Bosley S; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Dunn S; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
  • Zhu J; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Lee-O'Brien A; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Li L; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Therres J; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Chakrabarti L; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Khanal B; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Mowery R; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Arumugam S; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Klover J; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Taleb M; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Reier J; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
  • Hatton D; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
  • Schmelzer A; Cell Culture and Fermentation Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Biotechnol Bioeng ; 2023 Feb 01.
Article in English | MEDLINE | ID: covidwho-2219658
ABSTRACT
The global COVID-19 pandemic ignited an unprecedented race to develop vaccines and antibody therapeutics. AstraZeneca's pursuit to provide AZD7442 (EVUSHELD), two long-acting, SARS-CoV-2 spike receptor binding domain-specific neutralizing monoclonal antibodies, to individuals at risk on highly accelerated timelines challenged our traditional ways of process development and spurred the rapid adoption of novel approaches. Conventional upstream development processes were replaced by agile strategies that combined technological advances and highly accelerated workflows. With calculated business risks and close cross-functional collaborations, this process paved the way for hyper accelerated antibody development from discovery through manufacturing, process validation, emergency use authorization filing, and global regulatory approvals. The result was initiation of commercial manufacturing at a contract manufacturing organization less than 6 months from the selection of cilgavimab and tixagevimab-a process that historically has taken close to 10 years.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Year: 2023 Document Type: Article Affiliation country: Bit.28336

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Year: 2023 Document Type: Article Affiliation country: Bit.28336