The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...

Bioassay variability can pose significant challenges due to laboratory conditions, instrumentation, analytical software, cell culture performance and reagent sourcing. These inconsistencies can impact ...

DUBLIN--(BUSINESS WIRE)--The "Method Development and Validation for Assays Supporting Testing of Biologics" conference has been added to ResearchAndMarkets.com's offering. This 2-day seminar is ...

Figure 8: Major analytical performance measurements of the NeXT Personal assay. “NeXT Personal uses whole genome sequencing of tumor and matched normal samples combined with advanced analytics to ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

CHICAGO--(BUSINESS WIRE)--Tempus, a leader in artificial intelligence and precision medicine, today announced results from validation studies demonstrating the reliable analytical performance of the ...

PARP Inhibition in Prostate Cancer With Homologous Recombination Repair Alterations Literature searches were conducted in MEDLINE (via PubMed) and EMBASE to identify studies published between January ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...