Comprehensive mRNA analytics are essential to ensure the safety, efficacy, and quality of mRNA vaccines and therapeutics. As a leading provider of global product quality control and analytical testing services, Protheragen-ING Lab is committed to providing an outstanding customer experience for the pharmaceutical, biomedical, and medical device industries at every stage of the testing, development, and manufacturing process.
Our Services
Our mRNA analysis and detection services include the evaluation of key properties of mRNA molecules such as purity, integrity, and impurities.
mRNA Analytics Process Development
Complete cGMP characterization may not always be available when refining In Vitro Transcription and Lipid Nanoparticle (LNP) formulation strategies. Protheragen-ING Lab provides a suite of essential tests that are vital for achieving a swift turnaround time, all in a non-cGMP format.
Our common mRNA assays:
- Size, integrity, and purity of mRNA constructs via capillary electrophoresis
- In-Vitro transcription concentration via NanoDrop
- Impurity analysis (including dsRNA, pDNA, and residual protein)
- Polydispersity index of LNP formulations
- Particle size of LNP formulations
- Lipid identity via UPLC
mRNA Raw Material Testing
To ensure product quality, accurate analysis of raw materials used in in vitro transcription (IVT) and lipid nanoparticle (LNP) manufacturing processes is required. Protheragen-ING Lab specializes in cGMP raw material testing through USP and custom validated methods.
Our mRNA raw material testing programs include:
- Appearance
- Osmolality
- pH
- Bioburden
- Endotoxin
- Concentration
- mRNA Construct Identity
- mRNA Construct Sequence Confirmation
- Size, Integrity, Purity
- 5' Capping Efficiency
- 3' Poly A Tail Length
- Residual Plasmid DNA
- Residual Protein
- Double-stranded RNA Impurities
Cold Chain Service
Protheragen-ING Lab offers a range of standard stability storage services in cGMP-controlled environments, including cold chain. Cold chain stability studies are essential for the evaluation of the stability of mRNA and LNP encapsulated drug products. Protheragen-ING Lab has a wide range of -80 ℃ and -20 ℃ stability capabilities and specialized cold chain products and freeze-thaw evaluation for critical assay controls.
Our Service Process
- Analysis of requirements
We communicate with the customer, and learn about the character of mRNA products, intended use and regulatory requirements.
- Test scheme design
We design a detailed test plan according to the customer's needs, including test items, methods and evaluation criteria, etc., and confirm with the customer.
- Sample preparation
Our technicians prepare test samples according to standardized procedures to ensure representative and accurate tests.
- Laboratory tests
After preparing the assay protocol and samples, we perform various analytical assays on the mRNA samples in a professional laboratory environment using high-precision instrumentation.
- Data analysis
We perform in-depth analysis of test data to identify key quality and characterization metrics, as well as potential risk points.
- Preparation of reports
We prepare and feed back detailed test reports to customers, including test methods, results, assessments and recommendations.
- Follow-up support
Based on the test results, we provide improvement suggestions and technical support to help customers optimize the development and production of mRNA products.
Whether you're seeking assistance with raw material testing at the clinical stage or for the commercial release of a product, Protheragen-ING Lab is equipped to offer the appropriate solutions.
Contact us today to learn more about our mRNA analytics services or to inquire about customized testing solutions.