mRNA Characterisation, Analysis, and GMP Testing Services
mRNA characterisation, analysis, and GMP testing services – to ensure your mRNA therapy or vaccine product is safe, effective, and of high quality
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 gene therapies in clinical trials by the FDA and EMA, guidelines relating to these products can also be applied.
Expertise in mRNA Characterisation, Analysis, and GMP Testing
At our GLP / GCP / GMP laboratories, scientists can test an 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, residual solvents and elemental impurities, and compendial methods – including appearance, pH, osmolality, particulate matter, container closure integrity, sterility, and bacterial endotoxins. In addition, our experts offer a variety of mRNA-specific methods, including testing for mRNA integrity, potency, capping efficiency, residual DNA templates, residual dsRNA, and delivery system testing. We offer next-generation sequencing (NGS) services to confirm on-target/off-target effects, or to identify whether a viral sequence has been integrated correctly into a cell line. These comprehensive characterisation services provide data to determine protein expression and product purity, which can be directly linked to translation efficiency and immunogenicity.
Potency Assays for mRNA Therapies
We develop potency assays for mRNA therapies and vaccines based on the transfection of cell lines appropriate to the target construct. Relative potency is then demonstrated by quantitative and/or functional assays of the expressed protein. While the initial cell stage is often common between constructs, the readout typically requires the development of a bespoke functional assay or ELISA.
Advanced Delivery Technologies
Encapsulation of mRNA inside Lipid Nanoparticles (LNPs) provides stability, delivery, and safety advantages. LNPs typically have a single phospholipid outer layer which encapsulates and acts as vehicle for mRNA drug products (DPs). To help you meet CMC requirements, 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 are necessary to support the submission of an Investigational New Drug Application (IND).
Development of Inhaled and Nasal Delivery Solutions
Whilst mRNA drug products or vaccines are specific in their mode of action and are typically administered via sub-cutaneous or intravenous routes, the potential for inhaled or intranasal administration presents a more desirable mode of self-administration, resulting in an improved patient experience and compliance.
Our scientists provide complete development solutions for inhaled or nasal delivery including formulation, device selection / compatibility and analytical development from both the molecule (structure, physicochemical properties, potency) and delivery performance aspects (delivered dose, delivery rate, aerodynamic droplet size distribution, etc).
Total Quality Assurance for mRNA Therapy Development and QC
At Intertek Pharmaceutical Services, we believe that a best practice approach to supporting analytical development of mRNA therapies involves using orthogonal techniques that are ideally, sensitive, accurate and linear over a broad range. Additionally, 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. By integrating advanced analytical technology with a heritage supporting pharmaceutical product development, our experts offer Total Quality Assurance to help you ensure the safety, efficacy, and quality of your mRNA therapy.