Regulatory-compliant residual host cell DNA quantification for biopharmaceutical products using qPCR and highly sensitive fluorescence-based assays. Our validated methods detect trace amounts of contaminating DNA with sensitivity down to picogram levels, meeting FDA, EMA, and ICH guidelines. Critical for ensuring the safety of biologics, vaccines, cell therapy products, and recombinant proteins. Creative Proteomics provides complete documentation for regulatory submissions with rapid turnaround times to support your manufacturing and quality control processes.
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