With proven efficacy as vaccines for SARS-CoV-2, mRNA has revealed its versatility and the fast-to-market potential. mRNA may go beyond prophylactic vaccines and has a promising future as therapeutic vaccines for cancer and as therapeutics across multiple disease areas.
Given the unique characteristics of the mRNA/LNP complex, new expertise and a series of novel analytical capabilities are required to ensure fast, efficacious, and compliant mRNA drug products.
Our assay packages and phase appropriate assay development and validation capabilities provide the product and process knowledge you need to develop a Quality Target Product Profile (QTPP) and identify the Critical Quality Attributes (CQAs) to unchain the disruptive potential of your mRNA therapy.
You will benefit from a quantitative, comprehensive understanding of your mRNA assets to de-risk regulatory approvals through our best-in-class testing services, a leading bioinformatics platform, and robust regulatory and technical expertise.
To help you de-risk and expedite the product and process development of your mRNA vaccine or therapy, we offer a broad selection of assay packages for various stages of development and process control points. In addition, our capabilities in analytical development and stability testing services enable us as a partner in your journey of product and process development.
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Provides a detailed description of assays for sequence identification and LNP composition, two critical quality attributes of mRNA-LNP products.
Learn why Capillary Gel Electrophoresis is a suitable method for the assessment of mRNA integrity and purity.
Discover how UHPLC-CAD can be used to confirm the identity, quantity, and purity of lipids, ensuring the quality of mRNA-LNP drug products.
In this webinar, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substance and drug product.
See a high-level overview of our product characterization and lot release services for confirming critical quality attributes of mRNA-based products.
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