FORMULATION ARTICLES
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
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.
Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality & IP-related considerations for managing the supply chain for next-generation RNA modalities.
Compare sterilizing-grade membrane performance at high and low pressures, including throughput, bacterial retention, and the effects of filtration on particle diameter and encapsulation efficiency.
CRISPR gene editing and lipid nanoparticle delivery are revolutionizing precision medicine. Discover how optimized LNP systems and advanced analytics accelerate therapeutic development.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-1622519985 cryopreservation, cold chain]( "Building Stability Through Integrated Cryopreservation")
Early integration of standardized, GMP-aligned cryopreservation improves consistency, documentation, and scalability in advanced therapy programs as they progress toward regulatory submissions.
-
![vaccine, disease prevention-GettyImages-1155084813]( "Neoantigen-Based Personalized Cancer Vaccine")
Personalized cancer vaccines are advancing quickly, but effective delivery remains a major hurdle. Learn how mRNA and lipid nanoparticle design influence targeting, endosomal escape, and repeat dosing.
-
![GettyImages-1194781834-cell]( "mRNA-Lipid Nanoparticles Circumvent Viral Vector Limitations")
Both physical and chemical nonviral gene delivery systems for ex vivo genetic modification offer advantages over viral vectors, including smaller scale production and the low risk of immunogenicity.
-
![GettyImages-1275317360-lab-cell-gene-research-scientist-development-discovery]( "Scale-Up And Manufacturing Of Self-Amplifying RNA-LNPs")
This poster shows the work to scale up COVID-19 self-amplifying RNA-Lipid nanoparticle using PNI developed ionizable lipid and formulation from 0.2, to 50 mg scale using PNI’s Manufacturing Platform.
-
![GettyImages-2193391345-cryopreservation]( "How Operational Efficiency Shapes Late-Phase Manufacturability")
Prioritize operational efficiency over early-stage flexibility to scale advanced therapies. Standardized workflows and qualified shipping lanes reduce variability for predictable late-phase success.
-
![blood-cell_173710948-thinkstock_450x300]( "Hemophilia - Global Clinical Trial Landscape")
Delve into the clinical landscape of hemophilia, a rare X-linked congenital bleeding disorder, across three key regions of the globe, namely Asia Pacific, Europe, and North America.
-
![mRNA GettyImages-1356994723]( "The Future Of mRNA: Four Key Focuses For Industry")
Compared to traditional protein-based therapies, mRNA drugs exhibit unique pharmacokinetic profiles and can be rapidly developed, making overcoming their challenges critical for the industry.
