Vector Copy Number | Gene Copy Number

Vector Copy Number testing

Vector copy number plays a major role in a variety of applications. Some examples are the expression of recombinant proteins in eukaryotic cell lines (characterization of master or working cell banks, clone selection), the development of disease models or the targeted introduction of genes into ATMP products (GTMP). Whether in the context of your R&D activities, as part of a clinical trial or LOT release – the exact knowledge of the vector copy number introduced is critical to the understanding and safety of your therapeutic product and is required by  regulatory bodies. We are happy to assist you with the development and validation of qPCR systems, or validate our in-house system for your applications and routine analysis.

Background Information | Vector Copy Number Testing

Lentiviral systems are most frequently used for the transfer of a target genes. These transfer systems are classified according to distribution of viral genes and  user safety into generation 1 to 4 systems. Due to the large number of different gene transfer systems and targets, we have developed a system with the widest possible applicability. Here, a host cell gene and a lentiviral gene are quantified in a duplex assay and the vector copy number per host genome is determined. If our system is not or only partially applicable, we will gladly assist you in the development and validation of the missing parts or a corresponding overall system.

Vector Copy Number Testing Services | Overview

Vector Copy Number Testing service for research and development

Your quick entry into gene copy number determination. We are happy to perform a compatibility test with your transfer system and cell line for you in our GenTSV approved laboratory. The service includes the necessary sample preparation and testing by duplex qPCR.

Specific Vector Copy Number Systems

Your system is not or only partially compatible with our standard system? We are happy to develop and validate missing parts or even whole systems for you.

validation

According to ICH LOT-release testing requires assay validation. Therefore, Minerva Analytix GmbH offers customized method validation in a GMP environment with years of experience. More information: Validation