AccuSEQ integrated software for residual host cell DNA testing and mycoplasma detection testing

The AccuSEQ Real-Time PCR Software provides fast and easy data interpretation of analytical output from contaminants and impurities testing. This AccuSEQ software is a key component of an all-inclusive solution that provides you with the actionable results needed during biopharmaceutical manufacturing processes. The AccuSEQ Real-Time PCR Software is part of a complete validated solution from sample prep, real-time PCR, data analysis, and report output for contaminant and impurity testing.

The AccuSEQ software was developed to help optimize data interpretation when using our Applied Biosystems analytical solutions, as a component of an integrated workflow for mycoplasma detection and residual DNA quantitation.

banner-top
Bacteria
DNA
Viruses

The AccuSEQ software was designed to facilitate the data interpretation of essential tests required for GMP manufacturing, including in-process testing and lot-release testing.

  • Integrated, easy-to-use interface allows for consistency across multiple data applications and reduces the time needed to train your team
  • Automated presence/absence calls for mycoplasma detection
  • Accurate quantitation of host cell line residual DNA, including reporting of % recovery and total DNA per mL within the software
  • Single software platform for all current and future SEQ real-time PCR assays
  • Security, audit, and e-signature capabilities to help enable 21 CFR Part 11 compliance
  • Available for 7500 Fast and QuantStudio 5, 0.1mL Block PCR instruments for easy integration of SEQ solutions into your current QC laboratory

Getting the right start

custom-experiment

The AccuSEQ Software v3.1 dashboard is intuitive and user-friendly. Use the home page to start a new experiment, get immediate updates for ongoing experiments, and access quick links to the most recent experiments. Find your most recent experiments under “Home”. Check the status and time remaining of your real-time PCR run under “Monitor The Run”. Browse through factory default templates (validated and optimized templates for assays including MycoSEQ and resDNASEQ), user saved templates, or create custom templates to fit your needs under “Create New Experiment”.

Simple experiment plate set up

The AccuSEQ Software v3.1 plate set up interface provides customers a visual approach to setting up their experiment details on a 96-well plate. Users can input details (sample, controls, dilutions, etc.) and designate colors for each well, allowing for quick visualization of the 96-well layout. Table-view plate setup is also available. The “Define & Setup Standard” feature allows users to expedite their standards set up on the plate. Simply enter information about the target and standard curve parameters, and this feature provides well arrangement on the plate for the Standards.

AccuSEQ 3.1, mycoplasma detection qPCR testing software, plate setup


Mycoplasma detection using the AccuSEQ software

For rapid and accurate mycoplasma detection, the AccuSEQ software offers a plug-in analysis module for automated presence or absence calls when using the MycoSEQ Mycoplasma Detection system.

Key features and benefits:

  • Optimized and validated for the MycoSEQ Mycoplasma Detection assay
  • Automated detection of PCR inhibition in sample wells
  • Automated detection of discriminatory positive control (DPC)
  • Robust data analysis parameters for the MycoSEQ Mycoplasma Detection assay
  • Flexibility for experiments; call settings may also be modified to meet the specifications of individual laboratories
AccuSEQ 3.1, mycoplasma detection qPCR testing software, automated presence or absence calls

The AccuSEQ Software v3.1 shows the “automated presence or absence calls” of mycoplasma contamination.

AccuSEQ 3.1, mycoplasma detection qPCR testing software, results analysis with three acceptance criteria.

The AccuSEQ Software v3.1 shows the MycoSEQ “results analysis table” where calls are made based on the three acceptance criteria–Ct, Tm, and derivative value–of test samples and inhibition controls.

Residual host cell DNA analysis using AccuSEQ software

The AccuSEQ software offers factory default templates to facilitate experiment set up for the accurate and sensitive quantitation of host cell DNA impurities in both the purification process and in drug substance samples.

Key features and benefits:

  • Streamlined resDNASEQ experiment setup (using factory default templates) and data reporting
  • Automatic calculations of the resDNASEQ standard curve with curve fitting parameters
  • Accurate quantitation of samples with %CV
  • Computation of key metrics including % Recovery, Total DNA in pg/mL and pg DNA/mg Protein
  • Flexibility for custom experiments to meet the specifications of individual laboratories
  • Customizable output layout that can be exported to a variety of formats
  • Comprehensive reports which eliminate the need for Excel sheet for calculations and preserve the audit trail

For plate setup using the AccuSEQ Software v3.1, the user simply enters sample names, serial dilution factor, and spike-in information.

AccuSEQ 3.1 residual host cell DNA quantitation testing software, plate set up
AccuSEQ 3.1 residual host cell DNA quantitation testing software, standard curve set up

After the experiment run, the AccuSEQ Software v3.1 automatically sets up the standard curve calculations and provides a visual display of the results with relevant curve fitting parameters such as slope, intercept and efficiency, and R2.

AccuSEQ 3.1 residual host cell DNA quantitation testing software, standard curve plot

The AccuSEQ Software v3.1 shows the standard curve plot with samples overlayed and the results analysis tab on the right.

AccuSEQ 3.1 residual host cell DNA quantitation testing software, result analysis

The resDNASEQ Results Table in AccuSEQ Software v3.1 shows key metrics including Quantity Mean, Quantity %CV, % Recovery, Total DNA per mL, and Total DNA per Protein Concentration.

The report section allows results to be exported in multiple formats (.xls, .xlsx, .txt and .csv) and provides the ability to customize how this content appears in a printed report.

AccuSEQ 3.1 residual host cell DNA quantitation testing software, customize report content

The AccuSEQ Software v3.1 showing the Print report section where users can customize report contents.

AccuSEQ 3.1 residual host cell DNA quantitation testing software, result summary

Snapshot of the resDNASEQ “Result Summary” from the PDF report generated by the v3.1 software. The Comprehensive Result Summary includes all important metrics required in the resDNASEQ experiment such as %CV, %Recovery, and Total DNA per mL (dilution adjusted).

Custom experiments using AccuSEQ Software

There is also the custom experiment mode (“Create New”) where users can use the AccuSEQ software to create custom experiment setups. The custom mode guides the user through the experiment properties, qPCR run method details, and plate setup where there are easy-to-use tools for defining and setting up standards, controls, and unknowns. This custom workflow also supports ViralSEQ Mouse Minute Virus (MMV), Vesivirus, and resDNASEQ SF9-Baculovirus duplex assays.

AccuSEQ 3.1 residual host cell DNA quantitation testing software, custom experiment

The AccuSEQ Software v3.1 shows the custom (“Create New”) selection where users have the ability to create an experiment with their own specific and unique parameters. 

AccuSEQ 3.1 residual host cell DNA quantitation testing software, custom experiment

The AccuSEQ Software v3.1 shows the custom (“Create New”) selection where users have the ability to create an experiment differing from the default experiment templates. Users can choose the experiment type, reagent type, and ramp speed.

AccuSEQ 3.1 ViralSEQ software, amplification plot, results

Example of AccuSEQ 3.1 module for ViralSEQ MMV assay demonstrating the amplification readout.

Security, audit, and E-signature (SAE) feature and compliance services for AccuSEQ software

Security, audit, and E-signature (SAE) is a key feature of the AccuSEQ software as it supports our customers in meeting their local regulations like 21 CFR Part 11 compliance. The software security, audit, and electronic signature (SAE) manager includes options that let you easily organize and track your security settings, such as:

  • Security: username and password restrictions, and security policies such as password expiration and user account suspension
  • Audit: automatically audits changes to experiments in the AccuSEQ Software and modifications to settings in the SAE module, and sorts and prints audit records at the experiment and systems level
  • Electronic signature: selection of an electronic signature mode (enable or disable), on-demand electronic signature, electronic signature settings, number of electronic signatures required, and electronic signature actions (review, approve, or sign off)

Other key benefits include:

  • Database storage for improved data security
  • Customizable user role and permission
  • Two levels of auditing including comprehensive reporting of audit events

Since AccuSEQ software is validated with respective real-time PCR systems (7500Fast and QuantStudio 5, 0.1mL block), Thermo Fisher Scientific offers compliance services like IQOQ (Installation and operation qualification) and CSV (Computer system validations) services that save customers time and money with compliance audits. For more information on compliance services, please contact your local sales or field support representative.

AccuSEQ 3.1 software, audit records

The AccuSEQ Software v3.1 shows a summary of the audit records

AccuSEQ 3.1 software, SAE security, audit, e-signature Admin console

The AccuSEQ Software v3.1 SAE Admin Console displays where user roles are defined and assigned.

 AccuSEQ 3.1 software, audit report

This is an example of an audit report generated by the AccuSEQ Software v3.1.

Real-time PCR systems validated with AccuSEQ software

QuantStudio 5 Real-Time PCR Systems

The Applied Biosystems QuantStudio 5 0.1mL block system is the newer real-time PCR system validated with AccuSEQ Software v3.1.

Learn more about our QS5-0.1mL system ›

7500 real time PCR system

The Applied Biosystems 7500 Fast system is our real-time PCR system validated with AccuSEQ Software v2.1.2.

Learn more about our 7500 Fast system ›

 

Bioprocessing resources

Access a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing: