The AccuSEQ™ Real-Time PCR Detection Software is part of a system that performs analytical testing for impurities and contaminants during the biopharmaceutical manufacturing process. Designed to work with the 7500 Fast Real-Time PCR instrument, the software supports the SEQ family of analytical detection and quantitation assays. Security, audit, and signature capabilities help enable 21 CFR compliance. For rapid and accurate Mycoplasma detection, the AccuSEQ™ Software offers a plug-in analysis module for automated presence⁄ absence calls when using the MycoSEQ™ Mycoplasma Detection System. For host cell residual DNA quantitation, a custom module built into the main application can be used with the resDNASEQ™ CHO Residual DNA Quantitation System.
• Automated presence⁄absence calls for Mycoplasma detection
• Accurate quantitation of host cell line residual DNA
• Single software platform for all current and future SEQ Real-Time PCR assays
• Helps enable 21 CFR Part 11 compliance
Automated presence⁄absence calls for Mycoplasma detection
Advanced algorithms built into the AccuSEQ™ Software help enable automated presence⁄ absence calls for Mycoplasma contamination. Developed using the data interpretation guidelines for the MycoSEQ™ Mycoplasma Detection Assay, calls are made based on the Tm and derivative value of the test sample and the Ct value of the test sample and inhibition control. For in-depth review of the data, the AccuSEQ™ Software offers easy-to-use manual review tools, including a complete table of all Tm and Ct values, as well as amplification, multicomponent, and raw data plots. The AccuSEQ™ Mycoplasma SEQ experiment workflow provides a suggested plate layout, generates a reaction setup worksheet and plate layout diagram, includes pre-loaded thermal-cycling settings, and generates a summary of results and detailed reports that can be printed and saved as *.pdf, *.html, *.ppt, and *.xls files (Figure 1).
Automated residual DNA quantitation
Using the custom experiment mode, the AccuSEQ™ Software runs automated residual DNA quantitation experiments. The custom mode guides the user through the experiment and plate setup and provides easy-to-use tools for defining and setting up standards, controls, and unknowns. The user enters the number of concentrations for the standard curve, replicates, starting quantity, and serial dilution factor, and the software automatically sets up the standard curve. A customized template is available for the resDNASEQ™ CHO Residual DNA Quantitation Assay. After the run is complete, the quantities for the unknown samples, mean quantity of replicates, and standard deviation for the replicates are provided in a table format that can be exported as .pdf, .xls, or .txt formats (Figure 2).
Single software platform for all PCR assays
The AccuSEQ™ Software has been designed for use with all current and future SEQ assays through the use of plug-in modules. In combination with the 7500 Fast Real-Time PCR instrument, one platform can be used to run multiple analytical tests that are required to detect impurities and contaminants during the biopharmaceutical manufacturing process.
Helps enable 21 CFR Part 11 compliance
The AccuSEQ™ Software Security, Audit, and Electronic Signature (SAE) Manager (Figure 3) makes it easy to set up and manage the SAE requirements needed for compliance with the 21 CFR Part 11 guidance. These include:
• Security – User name and password restrictions and security policies, such as password expiration and user account suspension.
• Audit – Selection of an audit mode (Prompt⁄Silent), management of audit reasons, and sorting and printing of audit records at the experiment and system level
• Electronic Signature – Selection of an electronic signature mode (Enable⁄Disable), on-demand electronic signature, electronic signature settings, number of electronic signatures required, and electronic signature actions (Review⁄Approve⁄Sign Off) (Figure 3 and Figure 4).
For Research Use Only. Not for use in diagnostics procedures.
For Research Use Only. Not for use in diagnostic procedures.