FORMULATION ARTICLES
FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
FORMULATION VIDEOS
How PCR-based technology can accelerate mRNA development and manufacturing and design principles/critical parameters to enable the rapid development of lipids for RNA formulation.
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, share their thoughts on the scientific-research and CMC-related reasons that have made the lipid nanoparticle the “darling” of the delivery world for mRNA/RNA products today.
Explore the new capacity of our complete mRNA Ecosystem that offers a streamline service to develop, product, and release of both mRNA drug substance and drug product.
Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, share their expectations on which scientific advancements/characteristics will be most important for LNP-delivery of mRNA/RNA cargo in the future.
FORMULATION RESOURCES
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![GettyImages-1357908552]( "Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing")
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Fit-For-Purpose Lipids Can Accelerate, Scale, And Improve RNA-LNP Drugs")
Emerging biotech companies are investing in novel delivery capabilities to address different modalities' needs and extra-hepatic delivery. Explore steps to accelerate commercial nanomedicine delivery.
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![iStock-1295693740-covid-coronavirus-vaccine-mrna]( "Developing A Scalable RNA-LNP Drug Product For Clinical Translation")
Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.
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![mRNA GettyImages-1428646288]( "Establishing Analytical Methods For mRNA-Based Therapies")
Here, we provide a detailed description of assays for sequence identification and LNP composition, two CQAs of mRNA-LNP products, that support the development of safe and effective mRNA therapies.
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![GettyImages-1326811027-lab]( "New To mRNA Manufacturing? Considerations For Starting")
Explore considerations for starting mRNA manufacturing related to the following topics: DNA template, mRNA product - IVT, mRNA product - purification, LNP encapsulation, and fill-finish.
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![Outsourcing RNA Feature Image]( "How Outsourcing RNA-LNP Production Can Have A Competitive Advantage")
Manufacturing RNA-containing LNPs demands specialized expertise Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
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![GettyImages-1311518492-vaccine-vial]( "Expanding Into New Fields Of “Cell-Grow-Culture” For mRNA Transfection")
Learn about one path forward to navigate the pitfalls with mRNA transfection and a medium to assist in lentivirus-mediated transduction of human mesenchymal stromal/stem cells (hMSCs).
