Early Development & Construct Optimisation
Design support, construct refinement, and workflow scalability.
Services
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Develop & Manufacture
End-to-End RNA Development & Manufacturing
Southern RNA provides end-to-end contract development and manufacturing services for RNA therapeutics and vaccines. From early research material to GMP-aligned and clinical-grade supply, we partner with innovators to accelerate programmes while maintaining the highest quality standards.
We combine scientific expertise, flexible manufacturing platforms, and integrated analytical support to deliver reliable, regulatory-ready solutions for every stage of RNA product development.
PROBLEMS WE SOLVE
Bridging Innovation and Clinical Delivery
Fragmented Development & Delays
Multiple vendors and disconnected workflows slow programme progress and increase coordination risk. We provide a single, integrated partner from research to clinic.
Inconsistent Quality & Scalability Challenges
Variability in RNA or plasmid DNA quality can compromise results and delay scale-up. Our controlled, reproducible processes ensure consistent performance from R&D to clinical supply.
Regulatory & GMP Complexity
Navigating compliance requirements can be resource-intensive and high risk. We align development with GMP and regulatory expectations from the outset.
Limited Analytical & Process Continuity
Gaps in analytical support and process handovers increase development risk. Our integrated platform ensures traceability, documentation, and seamless progression at every stage.
SERVICE & SCOPE
Flexible Services Aligned to Your Program Stage
Our CDMO capabilities cover the RNA product lifecycle, offering tailored solutions for each stage. From design to clinical-grade manufacturing, we adapt to project size and regulatory needs. By aligning with your milestones, we ensure seamless progression, reduce handovers, and maintain data continuity, allowing clients to accelerate timelines and focus on innovation.
Process Development & Scale-Up
Robust, reproducible manufacturing from research-grade to clinical production.
Analytical & Characterisation Services
Identity, purity, impurity profiling, and stability testing under controlled documentation.
Manufacturing & Release
Supply of research to clinical-grade mRNA and plasmid DNA, complete with regulatory 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 process development team designs robust, reproducible methods, using data to guide optimisation and scale-up. This ensures smooth transition from research-grade material to GMP-aligned production while maintaining product quality.
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In-house analytical capabilities provide identity verification, purity and impurity profiling, and stability assessment. Coupled with rigorous quality oversight, this ensures all outputs meet regulatory standards and programme requirements.
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Our manufacturing infrastructure can adapt to different project scales, delivering research to clinical-grade RNA with complete documentation. This flexibility ensures reliable supply for early-phase trials and smooth regulatory submission.
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
Test & Release
We provide a comprehensive nucleic acid analytical platform, supported by the deep expertise and experience of our multidisciplinary scientific team.
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