Our analytical capabilities help assess critical quality attributes including particle size, distribution, encapsulation efficiency, surface charge, composition, purity and stability, supporting product consistency and performance.
Lipid nanoparticles are central to the delivery of mRNA therapeutics, vaccines and other nucleic acid-based products, and their performance depends on tightly controlled particle attributes. Properties such as particle size, encapsulation efficiency, composition and stability must be understood to ensure consistent delivery and product integrity.
We provide comprehensive LNP characterization that delivers deep insight into these critical quality attributes. Our analytical services support both drug substances and finished products, helping you understand formulation behaviour and delivery efficiency from development to commercial manufacturing.
Understand and control your LNP formulations
- Assess critical particle attributes
Characterize particle size, distribution, encapsulation efficiency, surface charge, composition, purity and stability.
- Ensure consistent delivery
Gain insight into formulation behaviour and delivery efficiency to support reliable product performance.
- Support product integrity
Characterize both drug substances and finished products to support integrity throughout development and manufacturing.
- Validate robust analytical methods
Apply method development and validation tailored to complex LNP formulations, aligned to ICH guidelines.
- Build regulatory confidence
Generate data within GLP, GMP and GCP-compliant environments to support product consistency and compliance.
Our LNP characterization services
- Particle characterization
We assess particle size, distribution, surface charge and composition to control critical quality attributes.
- Encapsulation and purity analysis
We evaluate encapsulation efficiency and purity to support delivery performance and product integrity.
- Stability testing
We assess stability to support product consistency throughout development and manufacturing.
- Drug substance and finished product testing
We characterize both drug substances and finished products to understand formulation behavior and delivery efficiency.
- Method development and validation
We develop and validate robust, reproducible methods for complex LNP formulations in line with ICH Q2 and within GLP, GMP and GCP-compliant environments as appropriate.
Why SGS?
As the world’s leading testing, inspection and certification company, we bring deep analytical expertise and a global laboratory network to advanced therapeutics and nucleic acid-based platforms. Our specialists understand the complexity of lipid nanoparticle formulations and apply accredited, independent methods to deliver dependable results.
We support LNP characterization and analytical work from early-stage development through clinical and commercial manufacturing, 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
We support the development of mRNA therapeutics, vaccines and other nucleic acid-based products that use lipid nanoparticle delivery systems, characterizing both drug substances and finished products.
By characterizing both drug substances and finished products, we help you understand formulation behavior, delivery efficiency and product integrity throughout development and manufacturing.
Yes. We provide method development and validation tailored specifically to complex LNP formulations, ensuring methods are robust and reproducible. Validation is carried out in accordance with ICH guidelines, including ICH Q2, and performed within GLP, GMP and GCP-compliant environments as appropriate.