Learn how to evaluate mycoplasma qPCR testing for biologics, including LoD, target coverage, matrix suitability, controls, and Spiroplasma detection.
Resources & Insights
Learn how residual host cell DNA testing by qPCR differs for CHO and E. coli workflows, and how to assess LoD, LoQ, linearity, recovery, and controls.
Caris’ NYSDOH application for a blood-based molecular profiling test highlights reagent and QC priorities for cfDNA extraction, NGS library prep, qPCR verification and OEM diagnostics.
Recent mRNA manufacturing capacity shifts highlight why raw material strategy matters. This guide covers GMP-grade IVT enzymes, capping, DNase cleanup, QC and OEM planning for resilient RNA programs.
Foundation Medicine’s new collaboration with Fulgent Genetics highlights rising clinical demand for pharmacogenomic testing. This guide explains reagent, QC and OEM considerations for diagnostic teams.
CareDx’s Naveris acquisition highlights rising interest in cfDNA MRD testing. This guide explains reagent, assay QC, sample prep and OEM considerations for molecular diagnostics teams.
New FDA Form 483 response guidance highlights documentation discipline. This guide explains what IVD reagent OEM teams should prepare for QC, CoA and traceability.
Applied BioCode’s new FDA-cleared KingFisher extraction workflow for its respiratory panel highlights why automated IVD reagents need robust QC, OEM documentation and platform compatibility.
A practical guide to NGS sample preparation for molecular diagnostics, covering input QC, library prep reagent selection, workflow consistency, and OEM considerations.
A practical guide to residual DNA testing in gene therapy and biomanufacturing QC, covering method selection, sample prep, HCP/HCD risk, and supplier considerations.
Explore the mRNA bird flu vaccine workflow, from GMP-grade IVT enzymes and capping to residual DNA and HCP testing for biopharma QC.
Enzyme-based library preparation is reshaping next-generation sequencing by simplifying DNA fragmentation, improving automation compatibility, and reducing sample loss. This article explains how enzymatic fragmentation is driving the NGS revolution.
