Early Development & Construct Optimisation
Identity & Purity Testing: sequence identity, concentration, purity, and residual/impurity profiling.
Services
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ANALYTICAL SERVICES
From Testing to
From Testing to
Product Release
Southern RNA provides comprehensive analytical services for nucleic acid products, supported by an experienced team of scientists and a robust analytical platform. We deliver precise testing and characterisation for plasmid DNA, mRNA, cap analogs, and related materials, alongside method development, validation, and stability study support. With advanced analytical instrumentation and GMP-aligned processes, we help ensure product quality, regulatory readiness, and reliable data throughout development.
PROBLEMS WE SOLVE
From Analysis to Actionable Data
Limited Analytical Expertise for Nucleic Acids
Many programmes lack specialised expertise for analysing complex nucleic acid products. Our experienced scientists provide tailored analytical strategies and validated methods to ensure accurate and reliable results.
Inconsistent or Incomplete Product Characterisation
Without comprehensive testing, product quality and performance can be difficult to confirm. We provide detailed analysis of plasmid DNA, mRNA, and related components to ensure consistency and integrity.
Challenges in Method Development & Validation
Developing and validating analytical assays can delay programme timelines. Our team supports method development, qualification, validation, and verification to establish reliable testing workflows.
Regulatory & Stability Study Requirements
Meeting regulatory expectations requires structured stability studies and documented analytical processes. We support the design and execution of stability studies to ensure compliance and long-term product quality.
SERVICE & SCOPE
Flexible Services Aligned to Your Program Stage
Our analytical platform supports nucleic acid products at every stage, from early characterisation through release and stability testing. We tailor testing strategies to your programme’s phase and regulatory needs, providing consistent, well- documented data that de-risks progression.
Process Development & Scale-Up
Integrity & Structural Analysis: RNA integrity, capping efficiency, poly(A) tail, and dsRNA content.
Analytical & Characterisation Services
Method Development & Validation: development, qualification, and validation of fit-for-purpose methods.
Manufacturing & Release
Stability & Release Testing: stability study design and release testing under controlled documentation.
OUR APPROACH
Integrated, Risk-Managed Development
At Southern RNA, we integrate expertise, efficiency, and compliance into a seamless development pathway. We collaborate with clients from construct design to clinical-grade manufacturing, tailoring workflows to meet goals. Each project benefits from coordinated development, analytical support, and quality oversight, ensuring continuity and traceability. By connecting research, scale-up, and manufacturing, we reduce risk and accelerate timelines, allowing clients to focus on innovation.
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Our team develops and qualifies fit-for-purpose analytical methods, using data to ensure accuracy, precision, and robustness.
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We perform identity, purity, integrity, and stability testing with rigorous quality oversight and full documentation.
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You receive clear, traceable data packages that support in-process control, release, and regulatory submissions.
QUALITY & COMPLIANCE
Compliance Is Not An Afterthought, It Is Foundational
Quality is central to Southern RNA. Our Quality Management System supports GMP operations and early-phase clinical manufacturing. From raw material qualification to final product release, every step follows documented procedures and risk assessments to ensure consistency and patient safety.
Compliance is embedded in our workflows, not just a final checkpoint. We maintain documentation systems, change management processes, and analytical verification to support regulatory submissions. By aligning quality oversight with execution, we help clients progress confidently from research to clinical supply.
Capabilities
Delivering Results You Can Trust
Southern RNA has successfully supported multiple RNA programmes from early research through clinical supply. While client confidentiality is strictly maintained, examples of our capabilities include:
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Scale-up of GMP-aligned mRNA for first-in-human trials
Efficiently increased production while maintaining quality and regulatory readiness for early clinical studies.
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Phase-Appropriate Quality Systems
Robust, stage-aligned quality documentation and controls that support development, tech transfer, and regulatory progression.
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Time-Critical Delivery
Streamlined workflows and responsive project management to meet tight timelines without compromising quality or compliance.
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Deep Technical Expertise
Hands-on scientific support across nucleic acid design, synthesis, purification, and advanced analytical testing.
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Regulatory-Focused Support
Comprehensive documentation and guidance aligned with clinical and regulatory expectations at every phase.
FAQS
Your Questions Answered
Our FAQ section addresses the most common technical and compliance queries, providing clarity on our capabilities, processes, and quality systems.
Yes, our facilities produce GMP-aligned and clinical-grade mRNA and plasmid DNA suitable for early-phase trials.
We follow GMP-aligned processes, robust documentation, and quality oversight to meet regulatory expectations and support submissions.
We offer flexible production from milligram-scale research material to multi-gram clinical-grade batches.
Yes, our in-house analytical team supports identity, purity, impurity profiling, and stability testing across all projects.
Absolutely. Our team develops reproducible processes for smooth transition from research-scale to GMP-aligned clinical production.
Other Services
Develop & Manufacture
We provide plasmid DNA (pDNA) and mRNA production using flexible platforms that deliver high-quality R&D and GMP- aligned grade materials at scalable volumes.
FIND OUT MOREHigh-Quality RNA & DNA Solutions
Southern RNA offers quality plasmid DNA and mRNA for research and clinical use. Our scalable production ensures consistent quality, aiding RNA-based therapies.
EXPLORE OUR PRODUCTS