GMP mRNA Testing

Expertise in mRNA Analysis and GMP Testing Supporting mRNA product development, we are adept at designing and conducting strategic characterisation and quality control programs, including formulation and stability assessment. These programs utilise high-end analytical instrumentation as well as a more traditional QC approach to generate validated analytical methods covering identity, quantity, purity, impurities (product and process related), and potency of the construct as well as of the delivery and container closure systems (extractables and leachables). At our GLP/GCP/GMP laboratories, scientists test mRNA drug substances or drug products to fully characterise the material, as well as for quality control (QC) purposes to help you confidently assess batch-to-batch manufacture, process repeatability, and general quality of mRNA produced. mRNA-specific Analytical Methods Our experts offer a variety of mRNA-specific methods, including testing for mRNA integrity, potency, capping efficiency, residual DNA templates, residual dsRNA, as well as delivery system efficacy and stability. In this quickly developing area, we are constantly re-evaluating the best approach and improving methodology as well as introducing new technology, the latest being the introduction in early 2023 of GMP next-generation sequencing (NGS) services to confirm sequence as well and to establish on-target/off-target effects. Link: https://www.intertek.com/pharmaceutical/biopharmaceuticals/mrna-characterisation-and-analysis/