Real-Time PCR (RT PCR), or quantitative PCR (QPCR), is a DNA sequence detection and quantitation method extensively used for DNA copy number detection, gene expression, SNP genotyping, adventitious agent detection, and many other applications in the fields of genomics research, drug R&D, and biologics testings.
Regulatory agencies require the demonstration of the copy number values of plasmids (integrated or non-integrated) remain the same over the entire use of a cell bank in its different forms, MCB, WCB and end of production cell bank. Also, regulatory agencies have safety requirements for the amount of residual DNA that may be present in the final form of a pharmaceutical product or vaccine after purification.
Avance Biosciences can perform a broad range qPCR assays using TaqMan® probes, meeting research grade or GLP/GMP compliance. Customers can select established real-time qPCR assays from Avance Biosciences’ assay list or from the Applied Biosystems website. Assay development, including assay design, validation, transfer and testing is also available.
Genomics & Biological Services
All Avance Services Include
Experienced scientists functioning as project managers or study directors
Controlled laboratory environment to prevent cross-contamination
Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination
Methods validated per ICH GLP/GMP guidelines – also research grade testing available
Projects customized and tailored to suit your needs
Independent quality unit assuring regulatory compliance
Transparent process flow and weekly report on project progress
Professional project reports ready for regulatory filing
Fast turn-around time & Competitive pricing