Viral Titer Test

Whether early in viral vector development, preparing for scale-up upstream or downstream production, or performing quality control release assays, measuring viral titers is a critical step. Confirming how many individual viral genomes are present per milliliter of solution and the infectivity of the virus is a common method for assessing viral titer and is a key quality attribute in bioprocess development. Creative Biogene offers a variety of advanced technologies for comprehensive characterization testing of viral titer that can be performed quickly and accurately.

Viral Titer Test

Viral Titer Test Overview

The titer is a direct data corroboration to detect the biological activity and potency of viral vectors and is one of the key indicators to evaluate their quality. During the development of viral vectors, accurate and rapid viral titer tests need to be established to evaluate the effectiveness of the process and the final quality of the product. Viral titers are divided into physical and biological titers. Physical titer counts the total number of live and dead virus particles present and is expressed as the number of virus particles per milliliter (VP/mL). Biological titer measures the infectivity and transduction capacity of the viral vector. Creative Biogene has developed a series of applications of specific antibody-based immunostaining and RT-PCR technologies that allow for rapid and sensitive detection of virus titers, ensuring high-quality products for our clients.

Virus Titer Testing Methods Offered by Creative Biogene

Creative Biogene offers a variety of advanced methods and tools for the detection of viral titers in accordance with the regulatory requirements of the European Pharmacopoeia and the demands of our customers' projects. These methods allow for easy and accurate rapid quantification of viral vector titers.

Quality Properties	Testing Method
Physical titer	DNA hybridization, real-time PCR (qPCR, ddPCR), optical density (A260/280), HPLC
Biological titer	Viral plaque assay: One of the most widely used methods for determining infection titer. Endpoint Dilution Assay (TCID₅₀) Immunofluorescence Foci Assay (IFA): An antibody-based staining method.

Advantages of Creative Biogene

GMP, FDA compliant testing equipment and methods.
Common assay methods and multi-angle analysis.
Advanced analytical technology, stable results and quality control.

Creative Biogene is committed to providing accurate and rapid viral titer tests to assess the potency of viral vectors, allowing our GMP production to take place under controlled conditions. We have the laboratory capabilities, BSL2 facilities and advanced instrumentation to ensure that the viral vectors produced for you meet regulatory requirements and turnaround times for gene therapy products. Contact us for more information on viral titer test and we will be happy to assist you.

* For research use only. Not intended for any clinical use.

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