mRNA Therapeutics & Vaccines

We offer a comprehensive range of testing services for mRNA therapeutics and vaccines, supporting product quality, safety, potency and stability throughout the development life cycle.

Our capabilities include analytical characterization and quality testing for mRNA drug substances, lipid nanoparticles (LNPs) and finished vaccine or therapeutic products. Additional services include bioanalytical support, method development and validation, potency assays, comparability studies, stability programs, microbiology and sterility testing, and GMP quality control testing for raw materials, drug substances and finished products.

We help assess critical quality attributes (CQA) for mRNA products, including identity, purity, integrity, encapsulation efficiency and stability. These assessments support regulatory expectations and provide robust data across mRNA drug substances, lipid nanoparticles and finished products.

We support mRNA therapeutic and vaccine programs from early research through clinical trials and commercial release. Analytical characterization and quality testing support the development of drug substances, LNPs and finished products, while method development and validation services ensure analytical methods remain robust and reproducible as programs progress.

Stability, comparability, microbiology, sterility and GMP quality control testing provide continued assurance of product quality and safety through clinical and commercial stages.

Our bioanalytical services support both preclinical and clinical studies, including pharmacokinetic (PK), biodistribution, immunogenicity and biomarker testing. These services help generate reliable data to support regulatory submissions and clinical trial programs for mRNA therapeutics and vaccines.

Yes. Our method development and validation services are tailored to complex mRNA platforms and aligned to global regulatory standards, including GLP, GMP and GCP requirements. This supports the generation of robust, compliant data for mRNA programs.

We provide GMP quality control testing for raw materials, drug substances and finished products. This is complemented by microbiology and sterility testing, stability programs, comparability studies and potency assays to support consistent product quality from development through commercial release.