Dataset Information

Process development of a SARS-CoV-2 nanoparticle vaccine.

ABSTRACT: One of the outcomes from the global COVID-19 pandemic caused by SARS-CoV-2 has been an acceleration of development timelines to provide treatments in a timely manner. For example, it has recently been demonstrated that the development of monoclonal antibody therapeutics from vector construction to IND submission can be achieved in five to six months rather than the traditional ten-to-twelve-month timeline using CHO cells [1], [2]. This timeline is predicated on leveraging existing, robust platforms for upstream and downstream processes, analytical methods, and formulation. These platforms also reduce; the requirement for ancillary studies such as cell line stability, or long-term product stability studies. Timeline duration was further reduced by employing a transient cell line for early material supply and using a stable cell pool to manufacture toxicology study materials. The development of non-antibody biologics utilizing traditional biomanufacturing processes in CHO cells within a similar timeline presents additional challenges, such as the lack of platform processes and additional analytical assay development. In this manuscript, we describe the rapid development of a robust and reproducible process for a two-component self-assembling protein nanoparticle vaccine for SARS-CoV-2. Our work has demonstrated a successful academia-industry partnership model that responded to the COVID-19 global pandemic quickly and efficiently and could improve our preparedness for future pandemic threats.

SUBMITTER: Martinez-Cano D

PROVIDER: S-EPMC10019920 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Process development of a SARS-CoV-2 nanoparticle vaccine.

Martinez-Cano Diandra D Ravichandran Rashmi R Le Huong H Wong H Edward HE Jagannathan Bharat B Liu Erik J EJ Bailey William W Yang Jane J Matthies Kelli K Barkhordarian Hedieh H Shah Bhavana B Srinivasan Nithya N Zhang Jun J Hsu Angel A Wypych Jette J Stevens Jennitte J Piedmonte Deirdre Murphy DM Miranda Les P LP Carter Lauren L Murphy Michael M King Neil P NP Soice Neil N

Process biochemistry (Barking, London, England) 20230317

One of the outcomes from the global COVID-19 pandemic caused by SARS-CoV-2 has been an acceleration of development timelines to provide treatments in a timely manner. For example, it has recently been demonstrated that the development of monoclonal antibody therapeutics from vector construction to IND submission can be achieved in five to six months rather than the traditional ten-to-twelve-month timeline using CHO cells [1], [2]. This timeline is predicated on leveraging existing, robust platfo ...[more]

PMID: 37013198

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Dataset Information

Process development of a SARS-CoV-2 nanoparticle vaccine.

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Process development of a SARS-CoV-2 nanoparticle vaccine.

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