mRNA Development

Scaling up mRNA rapidly and reliably for use as vaccines and therapeutics is an important step in moving a drug from novel concept to clinical trials. Given the flexibility of mRNA as a platform technology, mRNA is an ideal technology for responding to fast-moving diseases.

We're here to help you through the entire development phase whether it be mRNA testing, regulatory, or clinical trial materials so that you can lay down the best foundations for your process as you move towards manufacturing. We can help you choose the right materials at the development phase that meet compliance needs for your application to ensure your process is viable in terms of feasibility and scalability. Spanning from non-GMP to IPEC GMP-grade process chemicals, many of our pharma and biopharma materials are part of the Emprove^® Program and have all the documentation that you’ll need to go through qualification, risk assessment, and process optimization. The Emprove^® Program also covers filter and single-use components as well as select chromatography resins.

Characterization and Method Development

mRNA characterization is a necessary component of method development. We provide a wide range of products and services that meet your compliance standards for characterizing mRNA in biopharmaceutical applications, including:

• A complete workflow of U/HPLC & LC-MS columns, solvents, and reagents for the separation and analysis of drugs, mRNA, and other biomolecules.
• Milli-Q^® pure and ultrapure water purification systems that meet water quality requirements for mRNA applications
• High performance filtration tools, including Millipore^® filter membranes, filter holders, and syringe filters.
• An extensive selection of media, buffers and raw materials, plus industry-leading sterile filtration and single-use solutions for mRNA and molecule identification
• Expert method development and validation services for your microbiological testing

Plasmid DNA Production, mRNA Synthesis, and mRNA Purification

pDNA production and purification present several challenges due to the large size of the nucleic acid and its high viscosity, shear sensitivity and the similarities between the product and impurities. Additionally, scaling up mRNA synthesis and purification for the delivery of mRNA vaccines and in other biopharmaceutical applications requires purification products and tools that give consistent batch-to batch results. Our comprehensive portfolio of products and services for plasmid DNA production through mRNA synthesis and purification help you navigate through these challenges and can be used from the development phase through manufacturing allowing for easy scale-up of your process.

• Processing and formulation chemicals that span non-GMP production to IPEC GMP grade materials backed by regulatory support as part of the Emprove^® Program
• Clarification depth filters and pretreatment solutions provide efficient contaminant removal from process development through large-scale manufacturing
• Tangential flow filtration devices for simple small-scale evaluations that are linearly scalable for production
• Ion exchange chromatography resins with high purification efficiency and yield standards that can be easily scaled up from bench to manufacturing
• Chromatography membranes in a single-use and scalable format
• Sterile filters with product-specific testing data, quality statements, and regulatory information
• in vitro transcription enzymes and reagents and in vitro purification enzymes to complete your mRNA synthesis and purification workflow and maximize mRNA purification yields

mRNA Contract Development and Manufacturing Services

As part of our integrated mRNA CDMO, we support mRNA development and manufacturing from milligram to gram scale using the AmpTec^™ workflow. This covers all steps from pDNA to the final purified mRNA drug substance. Our portfolio and services address the most critical challenges in mRNA manufacturing enabling fast timelines and high-quality purified drug products. Learn more about our custom mRNA CDMO services here.

Lipid Nanoparticle (LNP) Formulation

We provide a variety of lipids to design the most appropriate lipid nanoparticle formulation and deliver your mRNA efficiently. Aside from lipids, we supply a variety of pharma raw materials including IPEC GMP compliant Emprove® Chemicals like solvents, buffers, salts, and stabilizers for liquid formulations.

• Our portfolio and custom high-quality GMP lipids are available in many formats (standard or custom blends) and have many benefits including optimized stability, solubility, and handling characteristics.
• High purity synthetic cholesterol available in amounts from grams to tons.

Preclinical Assessment

To ensure that drug and mRNA therapies are safe for patients, preclinical safety screening requires scalable products with exceptional reproducibility. We offer a reliable portfolio of assays and products, including:

• An assortment of qPCR solutions for each stage of your PCR amplification workflow, including PCR reagents, whole genome amplification kits, and additional consumables
• A wide selection of antibodies for ELISA and immune assessment that are validated across multiple applications and techniques for target specificity and are produced animal-free
• MILLIPLEX® Multiplex Immune Response assays, which provide robust assay performance that ensures you collect the highest quality data with lot-to-lot reproducibility
• ELISpot for vaccine efficacy testing, which helps researchers qualitatively and quantitatively visualize multiple secretory products for therapeutic applications
• Our customizable portfolio of MultiScreen® plates for ELISA, other assays, and storage, including plates that are automation compatible for high-throughput workflows
• Our range of pre-engineered biosensors, translational CRISPR RNPs, 3D cell culture chips and cell engineering services for better in vitro modelling and reduced clinical failure.

mRNA Development Services

In addition to high-quality products, our experts provide a variety of reliable services to help researchers in the biopharmaceutical sector develop new drugs and therapeutics. Our support and services include:

• End-to-end engineering and facility design services to help you make important decisions early in pharmaceutical and clinical development, acting as your trusted partner as you make key decisions for creating a reliable GMP biomanufacturing facility
• GMP-compliant product characterization, validation services, and release testing services to help you take your therapeutic product from conception to clinical testing to approval