FORMULATION ARTICLES
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![Future-GettyImages-834713748]( "Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions")
Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future DirectionsThis last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
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![Financial security, wealth protection, money insurance-GettyImages-2288391875]( "Protecting The Platform: Trade Secret Protection For RNA Biotech Companies")
Protecting The Platform: Trade Secret Protection For RNA Biotech CompaniesAs RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
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![Measuring Success GettyImages-1319232417]( "How Should We Measure The True Potency Of RNA Therapeutics?")
How Should We Measure The True Potency Of RNA Therapeutics?An RNA therapeutic can generate a strong molecular signal without producing the intended biological function. Let's look at how best to predict whether the RNA has completed its task.
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![business model-GettyImages-879532512]( "From Albumin To Oncology: Can Chemical Engineering Unlock Solid Tumor Delivery?")
From Albumin To Oncology: Can Chemical Engineering Unlock Solid Tumor Delivery?We discuss how selective albumin binding improved tumor delivery in preclinical studies and what these findings could mean for the future of siRNA-based cancer therapies.
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![Human Internal Organs Anatomy-GettyImages-1391174702]( "Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery")
Beyond GalNAc: Reengineering siRNA For Extrahepatic DeliveryWe discuss why effective extrahepatic delivery remains one of the field's biggest obstacles and how chemical engineering may provide a new path forward.
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![Asthma inhaler-GettyImages-2240010472]( "Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases")
Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic DiseasesTargeted lipid nanoparticles (LNPs) could deliver mRNA encoding a CAR directly to T cells inside a patient with allergic disease. The potential implications extend beyond a single allergic condition.
FORMULATION VIDEOS
Dr. Jason Coleman, Clinical Application Scientist Lead with Precision NanoSystems, presents on an overview of the development and scale-up activities needed to progress this saRNA vaccine to the clinic.
Unlock next-generation nanoparticle and LNP manufacturing. Achieve high throughput, minimal waste, and superior quality with a compact, automated, and contamination-controlled system.
Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.
Examine high-quality, GMP-compliant lipids that are engineered for pharmaceutical and gene therapy applications, with options ranging from standard formulations to custom blends for improved stability.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Cryopreservation GettyImages-172640159]( "Integrate Cryopreservation Into the End-To-End Supply Chain")
Cryopreservation should be integrated across the entire supply chain to ensure traceability, reduce risk at handoffs, and support consistent, scalable therapy development and delivery.
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![GettyImages-1327073953 scientist, lab, experiment, biomarker]( "Standardizing Cryopreservation For Cell Therapy Supply Chains")
Explore how a standardized cryopreservation process is transforming leukapheresis handling by reducing risk and improving quality across the cell therapy supply chain.
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![Cryoport]( "Why Risk Analysis And Lane Qualification Matter")
Risk analysis and lane qualification show supply chains perform consistently, meeting regulatory expectations by demonstrating control, reducing variability, and ensuring reliable delivery.
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![GettyImages-1298788278 drug manufacturing]( "Improving U.S. Drug Supply Stability Through Continuous Nanoparticle Processing")
Learn about a continuous manufacturing platform designed to help overcome challenges in domestic pharmaceutical production, including scale-up barriers and production variability.
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![cell-gene-therapy-GettyImages-2157300524]( "Safe, Scalable And GMP-Ready DNA")
Cell‑free synthetic DNA provides a scalable, safer alternative to plasmids by eliminating bacterial risks, simplifying quality control, and enabling complex sequences under GMP‑aligned conditions.
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Lipid Nanoparticle Compositional Analysis By UHPLC-CAD")
Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.
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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.
