Evaluation of physicochemical and functional similarity of a new CHO derived anti-EGFR antibody P-mAb to its reference medicinal product

Nandal, J. K.; Mihooliya, Kanti N.; Verma, Himanshu; Kalidas, Nidhi; Ashish, Fnu; Mishra, R. B.; Sahoo, Debendra K.

doi:10.1080/21691401.2022.2028284

Cited by 6 publications

(2 citation statements)

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“…In addition, CHO cell lines are capable of high cell-density growth and high productivity, making them one of the most favored expressions hosts for producing complex recombinant proteins at an industrial scale (41). We recently demonstrated the suitability of the CHO-S suspension cell line in combination with expression vector pCHO 1.0 for the high-yield expression complex protein like glycosylated monoclonal antibodies (20). However, this is for the first time that we are reporting the applicability of this cell line-vector combination for the expression of prefusion stabilized trimeric spike protein (IMT-CVAX) and its successful demonstration as a viable vaccine candidate against SARS-CoV-2 using pre-clinical models.…”

Section: Discussionmentioning

confidence: 99%

“…The designed gene construct was then exogenously expressed by using a combination of cGMP (current good manufacturing practices)-banked mammalian cell line (CHO-S) and expression vector (pCHO1.0) which permits achieving a high yield in a high-density cell culture system. Noteworthy, the feasibility and potential of this expression system have already been demonstrated in our recent research for the expression of industry-compatible recombinant monoclonal antibody (20).…”

Section: Introductionmentioning

confidence: 93%

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A broadly protective CHO cell expressed recombinant spike protein subunit vaccine (IMT-CVAX) against SARS-CoV-2

Jitender

Kumar

Singh

et al. 2023

Preprint

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Protective immunity induced by COVID-19 vaccines is mediated mainly by spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here, we report the development of a recombinant prefusion stabilized SARS-CoV-2 spike protein-subunit-based COVID-19 vaccine produced in the mammalian cell line. The gene encoding ectodomain (ECD) of the spike protein was engineered and cloned into Freedom pCHO 1.0, a mammalian expression vector, and subsequently expressed in the Chinese Hamster Ovary suspension cell line (CHO-S).The recombinant S protein ectodomain (hereafter referred to as IMT-CVAX) was purified using a combination of tangential flow filtration and liquid chromatography. Biochemical and biophysical characterization of IMT-CVAX was done to ensure its vital quality attributes. Intramuscular immunization of mice with two doses of adjuvanted IMT-CVAX elicited a strong anti-Spike IgG response.In pseudovirus-based assays, IMT-CVAX immune mice sera exhibited a broad-spectrum neutralization of several SARS-CoV-2 variants of concern (VoCs). Golden Syrian Hamster immunized with IMT-CVAX provided excellent protection against SARS-CoV-2 infection, and, hamster immune sera neutralized the live SARS-CoV-2 virus.The adjuvanted IMT-CVAX induced robust Tfh-cells response and germinal center (GC) reaction in human ACE2 receptor-expressing transgenic mice. The findings of this study may pave the way for developing next-generation protein subunit-based vaccines to combat the existing SARS-CoV-2 and its emerging VoCs. The IMT-CVAX is produced using a scalable process and can be used for large-scale vaccine production in an industrial setup.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 93%