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.

Vaccine Immunogenicity and Efficacy

In Vitro Immunogenicity

Immunogenicity studies are crucial in vaccine development, as they measure the ability of vaccine candidates to elicit a desired immune response. We offer a wide range of premier cell culture products and in vitro 2D and 3D cell culture tools that enable reliable in vitro immunogenicity testing using biologically relevant models. Our cell culture reagents give researchers more precise control over cell growth and maintenance, ensuring consistent and reliable results. Our in vitro 2D and 3D cell culture tools provide the necessary testing platforms to evaluate immunogenicity under conditions that better mimic the in vivo environment. We provide researchers with the necessary tools for successful analysis and development of lead candidates to support the development of more effective vaccines.

Download our brochure to learn more about our premier offering of cell culture reagents and in vitro 2D and 3D cell culture tools for in vitro immunogenicity.

In Vivo Efficacy

Immune modulation can be assessed using our immunoassay platform solutions. For qualitative analysis, SMC^® (Single Molecule Counting) technology offers superior sensitivity down to the single molecule level, facilitating detection of early humoral responses post-vaccination. For quantitative analyses, multiplexing MILLIPLEX^® panels can be used to measure humoral and cellular immune response.

We also provide an extensive array of products and services to support immunogenicity screening. Our vast selection of validated antibodies and innovative MultiScreen^® Plates for ELISA and ELISpot assays enable researchers to measure B and T cell response. MultiScreen^® plates can be customized with user-defined reagents and are available in an 8-well strip format for analysis of individual samples. ELISA plates come in medium or high binding capacity to compliment specific assay needs, while ELISpot plates feature mixed cellulose ester or hydrophobic PVDF membranes for high binding capacity and single cell-level resolution. In addition, our MultiScreen^® IP PVDF filter plates can be used for multiplexed fluorescent ELISpot assays, enabling multiparameter analysis of the immune response.

Transcriptome Profiling

Gene expression studies are crucial for immunogenicity screening in both in vivo and in vitro studies, providing valuable insights into the mechanisms and efficacy of vaccines. Emerging technologies such as RNA sequencing (RNA-Seq) and MULTI-Seq multiplexing offer greater accuracy, better sensitivity, and broader analytical capabilities for evaluating gene expression in response to vaccines.

These technologies generate a comprehensive view of the transcriptome, allowing for the analysis of complex gene expression patterns and identification of new biomarkers for vaccine efficacy.

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