Viral Contamination Detection via High-Throughput Sequencing
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Solution Overview
Problem
Current methods for detecting viral contamination in samples are laborious, limited to specific viral agents, and only determine presence or absence, lacking efficiency and comprehensive identification of viral types.
Innovation Solution
High-throughput sequencing (HTS) is used to sequence DNA and RNA in samples, comparing the results to a viral database to rapidly and accurately identify viral contaminants, regardless of their nature, and automate the process for in-process control in biomolecule production.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional analytical methods using reporter antibodies are used to detect viral contamination, then the presence or absence of specific viral contaminants can be determined, but the method becomes laborious and requires multiple samples and specific determinants for each viral agent
Solution Approach 1:
The patent applies universality by using high-throughput sequencing to detect all viral contaminants simultaneously regardless of their type, replacing the need for multiple specific reporter antibodies. The method sequences all DNA and RNA in a sample and compares against a comprehensive viral database, enabling one test to screen for any viral agent rather than requiring separate tests for each virus
Solution Approach 2:
The patent uses sequencing reads as copies of the viral genetic material. By obtaining multiple reads from the sample and comparing them to reference viral sequences in a database, the method creates digital copies that can be systematically analyzed to identify viral contaminants without requiring physical interaction with each viral agent
2Measurement precision
If traditional methods are used to determine viral contamination, then presence or absence can be assessed, but the nature and type of viral contamination cannot be identified
Solution Approach 1:
The patent introduces a viral database as an intermediary reference system. The database contains reference sequences for known viral contaminants and serves as a mediator between the sequencing reads and the identification of viral types. By comparing reads against this intermediary database, the method can systematically identify the nature and type of viral contamination
3Productivity
If high-throughput sequencing is used to sequence all DNA and RNA in a sample, then rapid detection of any viral contamination can be achieved, but the method requires sophisticated equipment and bioinformatic analysis
Solution Approach 1:
The patent replaces traditional mechanical/lab-based detection methods with automated high-throughput sequencing technology. The mechanical process of manually testing for specific viruses is substituted with automated sequencing machines that rapidly generate digital data, which is then processed through bioinformatic algorithms to identify contaminants
Data Source
AI summary
Described herein is a bioinformatic method for determining the presence of viral contamination in a sample and if such viral contamination is present the identification of the type(s) of contamination. The method uses high throughput sequencing techniques on DNA and/or RNA present in a sample. The methods described herein facilitate in-process control and r processing for release of batches, cell banks, bulk harvest and raw materials.