Our high-resolution identity testing confirms full sequence accuracy, 5’/3’ end integrity and critical regions, and structural consistency that can affect translation efficiency. It is designed to detect subtle sequence deviations and degradation.
mRNA products are highly sensitive to sequence errors and structural variation, and even subtle deviations or degradation can compromise efficacy or raise regulatory concerns. Confirming identity with precision is essential to maintaining quality through development and manufacturing.
We provide high-resolution identity testing that confirms full sequence accuracy, 5’/3’ end integrity and critical regions, and structural consistency affecting translation efficiency. Our testing supports a range of mRNA platforms, helping your products meet regulatory and quality expectations.
Confirm mRNA identity and integrity with confidence
- Confirm full sequence accuracy
Verify the complete sequence to detect subtle deviations that can compromise efficacy or trigger regulatory concerns.
- Verify end integrity and critical regions
Assess 5’/3’ end integrity and critical regions to support consistent product quality.
- Assess structural consistency
Evaluate structural consistency that affects translation efficiency across development and manufacturing.
- Support diverse mRNA platforms
Apply identity testing across vaccines, therapeutics and lipid nanoparticle (LNP)-based formulations.
- Support regulatory compliance
Rely on methods validated to ICH guidelines and aligned with current FDA and EMA expectations for mRNA products.
Our mRNA identity testing services
- Sequence identity testing
We confirm full sequence accuracy to detect subtle deviations and degradation that can affect efficacy or compliance.
- End integrity and critical region analysis
We assess 5’/3’ end integrity and critical regions to support product consistency.
- Structural consistency testing
We evaluate structural consistency that influences translation efficiency.
- Method development and validation
We develop and validate robust, reproducible methods in line with ICH Q2, within GLP, GMP and GCP-compliant environments, and aligned with current FDA and EMA expectations for mRNA products.
- Stability, impurity and potency testing
We provide stability studies, impurity profiling, potency testing and GMP quality control to support product consistency.
Why SGS?
As the world’s leading testing, inspection and certification company, we bring deep analytical expertise and a global laboratory network to advanced biologics and nucleic acid-based therapeutics. Our specialists understand the sensitivity of mRNA products and apply accredited, independent methods to deliver dependable results.
We support mRNA identity testing and analytical work from early development through commercialization, acting as a trusted partner across the product lifecycle. This combination of scientific depth, global scale and regulatory experience helps you move forward with confidence.
FAQs
Our testing capabilities support a range of mRNA platforms, including vaccines, therapeutics and lipid nanoparticle (LNP)-based formulations, helping products meet regulatory and quality expectations during development and manufacturing.
Yes. We provide method development and validation tailored to mRNA products, ensuring methods are robust and reproducible. Validation is carried out in accordance with ICH guidelines, including ICH Q2, within GLP, GMP and GCP-compliant environments as appropriate, and aligned with current FDA and EMA expectations for mRNA products.
Alongside identity testing, we provide stability studies, impurity profiling, potency testing and GMP quality control services to support product consistency and progression through clinical and commercial stages.