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qPCR Reagents

Articles from BIORI tagged “qPCR Reagents”. Guides, reagent insights and news across molecular diagnostics, NGS, mRNA and biopharma QC.

Biopharma QCmycoplasma qpcr testing biologics featured

Mycoplasma qPCR Testing for Biologics

Learn how to evaluate mycoplasma qPCR testing for biologics, including LoD, target coverage, matrix suitability, controls, and Spiroplasma detection.

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Biopharma QCresidual host cell dna testing qpcr hero

Residual Host Cell DNA Testing by qPCR: Choosing CHO or E. coli Assays

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.

10 min readRead
Molecular diagnosticsblood based molecular profiling reagent strategy cover

Blood-Based Molecular Profiling Reagent Strategy for Diagnostics

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.

6 min readRead
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IVD Reagent Quality Documentation for OEM Programs

New FDA Form 483 response guidance highlights documentation discipline. This guide explains what IVD reagent OEM teams should prepare for QC, CoA and traceability.

5 min readRead
Molecular diagnosticsautomated ivd reagents respiratory panels cover

Automated IVD Reagents for Respiratory Panels: QC and OEM Lessons

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.

5 min readRead
Biopharma QCresidual dna testing gene therapy manufacturing qc guide cover

Residual DNA Testing for Gene Therapy Manufacturing: A Practical QC Guide

A practical guide to residual DNA testing in gene therapy and biomanufacturing QC, covering method selection, sample prep, HCP/HCD risk, and supplier considerations.

5 min readRead
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