Sponsored content brought to you by
In 1997, Sanger, Nicklen and Coulson described a method for determining DNA nucleotide sequences.1 Nearly five decades later, Sanger sequencing remains an entrenched technology for targeted sequencing and fragment analysis.
Accuracy and unambiguous results are Sanger sequencing’s strong points. Without reliance on algorithms, alignment and intensive data analysis, the peak is the peak and easily compared to a reference. When focusing on a specific gene, mutation or sequence the high specificity and sensitivity of Sanger sequencing reigns supreme.
Sanger sequencing is widely used in infectious and rare disease research, vaccine development and mRNA QC, as well as in genome editing and plasmid confirmation. Unfortunately, many supporting software platforms have not kept pace with the growing needs of the biopharma, service provider and diagnostic markets, which
require process automation and secure data management in a
user-friendly format.
Enabling Automation and Compliance
The new InnoviGene™ Suite from Thermo Fisher Scientific is an all-in-one, browser-based platform that offers a suite of Sanger sequencing applications to enable regulatory compliance while increasing quality and productivity in a streamlined automated workflow.
“The user-friendly approach sets the InnoviGene Suite apart from many other bioinformatics suites that have more complicated menus and data management. The platform feels designed for a new user to come up to speed in 10 minutes,” remarked Wesley Morovic, PhD, Senior Research Scientist in the PPD™ clinical research business of Thermo Fisher Scientific.
The same SAE (security, audit, e-signature) model is utilized on both the InnoviGene Suite and the Applied Biosystems SeqStudio Flex Genetic Analyzer to support full automation of data analysis features for increased efficiency and decreased turnaround times. In addition, the InnoviGene Suite optimizes the use of the Applied Biosystems BigDye Terminator Sequencing kit to enhance data quality and reduce the need for resequencing.
Two software modules are currently available. The Sequence Quality Check module offers easy analysis, review, and reporting of sequence data and quality metrics, with the added benefit of AI-based Smart Deep Basecaller for high-throughput scenarios. Compliance with 21 CFR Part 11 is achieved with a dedicated console that permits electronic records, user management, tracking and process monitoring.
The Sequence Identity module is designed for accurate specimen sequencing confirmation and identifying mismatches against a reference. This module assists mRNA QC manufacturers to ascertain specimen traits and verify the precision of synthesized mRNA and is also particularly useful for plasmid sequencing.
InnoviGene in Action
The PPD clinical research business provides global contract research organization (CRO) services to deliver end-to-end, full-service solutions and customized strategies that cover every aspect of clinical testing. Morovic provides analytical services for gene and cell therapies with a focus on DNA sequencing methods.
For identification of gene and cell therapy drug components, Thermo Fisher has a robust platform for Sanger sequencing. Core to the process is the QC of traces, generation of sequences, quality trimming, and assembly. Sanger sequencing applications range from transgene identification for recombinant AAVs, mRNA sequence
identity for vaccines, to the identity of plasmids used to produce
therapeutic substances.
PPD’s IT Installation team must qualify any new software or equipment to ensure proper management according to the company’s Quality Standards. A primary consideration is the compliance to 21 CFR Part 11, including controls like increased security measures, audit trails, and report generation.
After Morovic evaluated the InnoviGene Suite he emphasized that “InnoviGene has the potential to help decrease a lot of the complexity that still exists historically with many software platforms in performing quality assessments and data management of our Sanger sequencing reads.”
Companies involved in next-generation drug development now have access to a new unified, browser-based CE software platform with enhanced built-in automated capabilities to manage Sanger sequencing analysis and results.
Reference
1. Sanger F, Nicklen S, Coulson AR. DNA sequencing with chain-terminating inhibitors. Proc Natl Acad Sci U S A. 1977 Dec;74(12):5463-7. doi: 10.1073/pnas.74.12.5463.
Learn more thermofisher.com
For Research Use Only. Not for use in diagnostic procedures.
