mRNA Characterisation and Analysis
mRNA characterisation and analysis services supporting therapeutic and vaccine development to assess clinical translation efficiency and immunogenicity.
mRNA characterisation and analysis is a critical requirement to assess drug product or drug substance quality and efficacy. Due to complexities in the synthetic manufacture of mRNA, and the presence of potential impurities, robust, analytical GMP testing is required to assess therapeutic mRNA and associated advanced delivery systems during development and to support IND submissions.
From a regulatory perspective, there is no specific ICH or FDA guidance for mRNA-based therapeutics, however, principles of existing regulations can be applied including FDA CFR Title 21 for CMC information as well as ICH guidelines for cGMP, method validations, elemental impurities, residual solvents and setting specifications. As mRNA therapies have been considered as gene therapies in clinical trials by the FDA and EMA, guidelines relating to these products can also be applied.
mRNA Characterisation Expertise
At our GLP / GCP / GMP laboratories, scientists can test a mRNA drug substance or drug product to help you confidently assess batch to batch manufacture and process repeatability as well as the quality of mRNA produced. We are adept in establishing GMP validated analytical methods including general methods, such as identification, assay, content uniformity, residual solvents and elemental impurities, and compendial methods including appearance, pH, osmolality, particulate matter, container closure integrity, sterility and bacterial endotoxins. Additionally, our experts provide mRNA specific methods including integrity, potency, capping efficiency, residual DNA template, residual dsRNA and delivery system testing. These comprehensive characterisation services provide data to determine protein expression and product purity, which can be directly linked to translation efficiency and immunogenicity.
Advanced Delivery Technologies
Encapsulation of mRNA inside Lipid Nanoparticles (LNPs) provides stability, delivery and safety advantages. In April 2018, the FDA published liposome drug guidance for industry. Although this was published by the Centre for Drug Evaluation and Research rather than the Centre for Biologics many of the scientific principles described in the guidance can also be applied to biological therapies.
To help you meet the requirements of the FDA CMC guidance our scientists provide a package of analytical services aimed at the assessment of critical quality attributes (CQAs), such as physicochemical properties, lipid content/composition, encapsulation efficiency and the release of drugs from the LNP formulation which is necessary to support the submission of an Investigational New Drug Application (IND).
Total Quality Assurance
At Intertek, we believe a best practice approach to supporting analytical development of mRNA therapies involves orthogonal techniques that are ideally, sensitive, accurate and linear over a broad range. In addition, methods should be validated appropriately to support the relevant phase of clinical development, regulatory submission requirements or to support ongoing quality control of the approved product. With a heritage of supporting advanced pharmaceutical product development coupled with a comprehensive range of state-of-the-art analytical technology, our experts offer Total Quality Assurance to help you ensure the safety, efficacy and quality of your mRNA therapy.