FORMULATION ARTICLES
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Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions
This 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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Protecting The Platform: Trade Secret Protection For RNA Biotech Companies
As RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
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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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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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Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery
We 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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Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
Targeted 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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
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The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
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Cryopreservation eliminates rigid timelines by decoupling collection from production, providing the flexibility needed to optimize facility use and stabilize advanced therapy supply chains.
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What solutions did the client featured in this case study find when they sought help in transferring their formulation process to a turbulent Impinged Jet Mixing (IJM)?
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Audit-ready cryopreservation workflows reduce risk, protect biological integrity, and support compliant scaling from research through commercialization.
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As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.