What began as modest research has grown into a bustling lab—with oligonucleotide projects piling up. Rising throughput brings new hurdles: vast datasets need strict quality control (QC), and regulatory standards make accuracy essential.
In a recent webinar, Brian Rivera (Software Product Manager, Agilent) explored the complexities of oligonucleotide QC and introduced digital tools designed to streamline and scale workflows. Here, we summarize key insights from his presentation on how these tools support lab growth and regulatory compliance.
Which labs benefit most from implementing specialized QC software?
Labs running purity, assay, and impurity profiling benefit significantly from QC software. Automating steps such as peak integration and ion classification reduces time on repetitive tasks, helping labs scale without additional resources. Compliance-driven labs also gain from built-in audit trails and documentation, which simplify regulatory reporting.
How does fit-for-purpose QC software benefit oligonucleotide workflows?
Fit-for-purpose software is built to manage specific workflows, tasks, and regulatory standards right out of the box. The Agilent Oligo Analysis Accelerator (OAA), designed for oligonucleotide QC, functions as an add-on within OpenLab Chromatography Data System, a widely-used data management system in regulated labs. Unlike general liquid chromatography-mass spectrometry (LC-MS) software, which often requires customization, OAA automates oligo-specific tasks such as ion classification, impurity profiling, and peak integration. Its user-friendly interface streamlines LC-MS analysis by focusing on essential signals and data, particularly for single-stranded oligonucleotides.
How does OAA streamline oligonucleotide analysis?
OAA automates ion classification by matching ions that exceed defined thresholds with known impurities, adducts, and degradation products. This reduces manual, error-prone work, ensuring accurate classification while saving time and enhancing data reliability.
Can OAA analyze complex oligonucleotides such as siRNA and duplexes?
OAA works best with single-stranded oligonucleotides, such as antisense strands. For siRNA, it can assess individual sense and antisense strands but may struggle with duplexes, where sense and antisense strands are likely to co-elute. While this software currently focuses on single-stranded applications, labs working with duplexes may explore other specialized approaches.
Why was OAA developed for single-quadrupole MS instead of high-resolution MS?
OAA was built to offer cost-effective, consistent performance in high-throughput QC settings. By isolating oligonucleotides into a single -4 charge state, it simplifies data interpretation and ensures accurate results on single-quadrupole systems. While high-resolution MS, including Time-of-Flight (TOF) instruments, provides greater detail, OAA focuses on delivering reliable QC outcomes without the added complexity and cost of high-resolution methods.
How adaptable is OAA to different oligos and variable sample types?
OAA can handle both purified and crude, unpurified samples, making it especially useful for in-process testing during process development. It supports a variety of oligonucleotide types with only minor method adjustments, such as slight tweaks to gradient profiles or MS settings, allowing labs to manage complex matrices without extensive re-optimization.
How does OAA support data integrity and regulatory compliance?
OAA integrates with OpenLab CDS to ensure data integrity through audit trails, secure logs, and comprehensive change tracking. Manual adjustments are fully documented for traceability, while automated and manual peak integration maintain workflow flexibility. After reviewing results, users can generate compliant reports with e-signatures, streamlining regulatory approval.
High-throughput oligonucleotide QC can be resource-intensive without the right tools. By reducing manual steps and providing custom adjustments for specific impurities, fit-for-purpose software enhances precision, accelerates data processing, and minimizes variability.
To see how these solutions can transform your lab, watch the webinar Boost Efficiency in Oligonucleotide QC with Software Designed for the Job, presented by Brian Rivera.
For more details, explore Agilent’s technical note Purity, Assay, and Impurity Profiling of Single-Stranded Oligonucleotides Using the Agilent Oligo Analysis Accelerator for OpenLab CDS. This resource covers automated workflows, flexible integration, and comprehensive compliance support to optimize your lab's QC processes.
Brian Rivera
Software Product Manager, Agilent Technologies
Brian Rivera is a software product manager at Agilent Technologies with 20 years of experience in HPLC analysis of large molecules.
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