White Paper

More Than Just A Sequence: Using Next Generation Sequencing Methods For Virus Vector Identity Testing

Scientist laboratory pipette GettyImages-1140779660

Sequence identity confirmation for genetically modified products is a regulatory expectation to demonstrate that the product contains the intended sequence. This is relevant to products such as virus-based vaccines, virus seeds, and viral vectors used in gene therapy applications, as well as nucleic acid based therapeutic products such as plasmids or RNA. Identity testing is usually established early in the development process and performed on starting materials such as plasmids or virus seed stocks. Following production, sequencing can also be used to establish vector identity and production consistency.

Identity testing can be performed using a variety of molecular-based methods ranging from restriction enzyme analysis and product-specific PCR methods to sequencing.  The strategy for establishing identity using one of these methods may differ depending on the product and stage of product development.  However, sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products.

Regulators set high expectations on drug manufacturers to establish the sequence identity and stability of viral and non-viral vectors used for gene delivery. Next generation sequencing (NGS), also known as high-throughput sequencing, has emerged as a useful state-of-the-art method to establish product quality through sequence identity. 

access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Bioprocess Online? Subscribe today.

Subscribe to Bioprocess Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Bioprocess Online