mRNA Analytics - Protheragen-ING Lab

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.

mRNA

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.

Services