Validation of a quantitative flow cytometer assay for monitoring HER-2/neu expression level in cell-based cancer immunotherapy products

a b s t r a c t GVAX Ò immunotherapy for prostate cancer is comprised of two genetically modified prostate cancer cell lines, CG1940 and CG8711, engineered to secrete granulocyte macrophage-colony-stimulating factor. As part of the matrix of potency assays, CG1940 and CG8711 are tested for the expression level of cell surface HER-2/neu using a quantitative flow cytometer assay. This assay reports the antibody binding capacity value of the cells as a measure of HER-2/neu expression using cells immediately after thawing from cryogenic storage. With optimized cell handling and staining procedure and appropriate system suitability controls, the assay was validated as a quantitative assay. The validation results showed that assay accuracy, specificity, precision, linearity, and range were suitable for the intended use of ensuring lot-tolot consistency of HER-2/neu expression. Assay robustness was demonstrated using design of experiments that evaluated critical assay parameters. Finally, the assay was successfully transferred to a current good manufacturing practice Quality Control laboratory in a separate facility. Since the overall precision of this assay is better than that of ELISA methods and it can be performed with ease and high throughput, quantitative flow cytometer-based assays may be an appropriate immunological assay platform for Quality Control laboratories for characterization and release of cell-based therapies

Systematic evaluation of multiple qPCR platforms, NanoString and miRNA-Seq for microRNA biomarker discovery in human biofluids

10.1038/s41598-021-83365-zScientific Reports111443

Quarantine measures for coronavirus disease 2019 on a cruise ship, Taiwan, February 2020

To early detect coronavirus disease 2019 on an international cruise ship and prevent its spread, Taiwan’s Central Epidemic Command Center implemented on-board quarantine measures on a cruise ship docked at the Port of Keelung, Taiwan, on February 8, 2020. Quarantine officers, medical professionals, and administrative staff from competent authorities conducted fever screening and investigated the present illness and travel history of 1738 passengers and 776 crew members on the ship. Throat swabs were collected from 128 (5.1%) passengers and crew members with fever or respiratory symptoms during the past 14 days or travel history to China, Hong Kong, or Macao within 30 days. All swabs tested negative for severe acute respiratory syndrome coronavirus 2 at the national reference laboratory. The whole process, from on-board preparation to the completion of testing, took 9 h. All passengers and crew were permitted to disembark and were required to take 14-day self-health management measures. No cases were reported by the end of the self-health management period

Search for heavy resonances decaying into a vector boson and a Higgs boson in final states with charged leptons, neutrinos, and b quarks

A search for heavy resonances decaying to a Higgs boson and a vector boson is presented. The analysis is performed using data samples collected in 2015 by the CMS experiment at the LHC in proton-proton collisions at a center-of-mass energy of 13 TeV, corresponding to integrated luminosities of 2.2-2.5 inverse femtobarns. The search is performed in channels in which the vector boson decays into leptonic final states ($\mathrm{Z} \to \nu\nu$, $\mathrm{W}\to \ell \nu$, and $\mathrm{Z} \to \ell \ell$, with $\ell = \mathrm{e}$, $\mu$), while the Higgs boson decays to collimated b quark pairs detected as a single massive jet. The discriminating power of a jet mass requirement and a b jet tagging algorithm are exploited to suppress the standard model backgrounds. The event yields observed in data are consistent with the background expectation. In the context of a theoretical model with a heavy vector triplet, a resonance with mass less than 2 TeV is excluded at 95% confidence level. The results are also interpreted in terms of limits on the parameters of the model, improving on the reach of previous searches

Search for heavy resonances decaying into a vector boson and a Higgs boson in final states with charged leptons, neutrinos, and b quarks

A search for heavy resonances decaying to a Higgs boson and a vector boson is presented. The analysis is performed using data samples collected in 2015 by the CMS experiment at the LHC in proton–proton collisions at a center-of-mass energy of 13 TeV, corresponding to integrated luminosities of 2.2–2.5 fb$^{−1}$ . The search is performed in channels in which the vector boson decays into leptonic final states (Z → $\nu\nu$ , W → ℓ $\nu$, and Z → ℓℓ , with ℓ = e, $\mu$), while the Higgs boson decays to collimated b quark pairs detected as a single massive jet. The discriminating power of a jet mass requirement and a b jet tagging algorithm are exploited to suppress the standard model backgrounds. The event yields observed in data are consistent with the background expectation. In the context of a theoretical model with a heavy vector triplet, a resonance with mass less than 2 TeV is excluded at 95% confidence level. The results are also interpreted in terms of limits on the parameters of the model, improving on the reach of previous searches