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High throughput chromatography and analytics can inform viral clearance capabilities during downstream process development for biologics.
Gulla, Krishana C; Schneiderman, Zachary J; O'Connell, Sarah E; Arias, Gabriel F; Cibelli, Nicole L; Cetlin, David; Gowetski, Daniel B.
Afiliação
  • Gulla KC; Vaccine Production Program Laboratory, VRC/NIAID/NIH, Gaithersburg, Maryland, USA.
  • Schneiderman ZJ; Vaccine Production Program Laboratory, VRC/NIAID/NIH, Gaithersburg, Maryland, USA.
  • O'Connell SE; Vaccine Production Program Laboratory, VRC/NIAID/NIH, Gaithersburg, Maryland, USA.
  • Arias GF; Vaccine Production Program Laboratory, VRC/NIAID/NIH, Gaithersburg, Maryland, USA.
  • Cibelli NL; Vaccine Production Program Laboratory, VRC/NIAID/NIH, Gaithersburg, Maryland, USA.
  • Cetlin D; Research and Development, Cygnus Technologies, Southport, North Carolina, USA.
  • Gowetski DB; Vaccine Production Program Laboratory, VRC/NIAID/NIH, Gaithersburg, Maryland, USA.
Biotechnol J ; 16(9): e2000641, 2021 Sep.
Article em En | MEDLINE | ID: mdl-34174016
ABSTRACT
High throughput process development (HTPD) using liquid handling robotics and RoboColumns is an established methodology in downstream process development to screen chromatography resins and optimize process designs to meet target product profiles. However, HTPD is not yet widely available for use in viral clearance capability of the resin due to a variety of constraints. In the present study, a BSL-1-compatible, non-infectious MVM model, MVM-VLP, was tested for viral clearance assessment with various resin and membrane chromatography operations in a HTPD mode. To detect the MVM-VLP in the high throughput experiments, an electrochemiluminescence immunoassay (ECLIA) assay was developed with up to 5 logs of dynamic range. Storage time suitability of MVM-VLP solutions in various buffer matrices, in the presence or absence of a glycoprotein vaccine candidate, were assessed. Then, MVM-VLP and a test article monoclonal antibody (mAb) were used in a HTPD design that included commercially available ion exchange media chemistries, elucidating a wide variety of viral clearance ability at different operating conditions. The methodologies described herein have the potential to be a part of the process design stage in biologics manufacturing process development, which in turn can reduce risk associated with viral clearance validation studies.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Vacinas Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Vacinas Idioma: En Ano de publicação: 2021 Tipo de documento: Article