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Switching the LNP Without Starting Over: What Can Carry Over—and What Must Be Rebuilt?
The same mRNA sequence can survive a formulation change. The same drug product does not. A practical framework for separating reusable knowledge…
Oct 22
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RapidGene
Abogen–Novartis: What Changes When the Body Makes the T Cell Engager?
ABO2203 delivers instructions for a therapeutic protein. Early human observations show why the amount produced, its duration and its function matter…
Oct 3
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RapidGene
Why Large RNA Cargo May Change the “Best” LNP
A mouse study screened ionizable lipids with a 5.7-kb editor-sized mRNA. The development question is whether a formulation screen represents the…
Oct 3
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RapidGene
September 2026
When AI Found a Warmer Path for mRNA Vaccines
Six experimental rounds produced solid-state LNP formulations that withstood 37°C storage in a preclinical study. The harder question is how to turn…
Sep 29
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RapidGene
What Should an Autonomous LNP Lab Optimize?
MIT’s automated process platform and a separate study of RNA placement inside nanoparticles point to a useful development question: which measurements…
Sep 27
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RapidGene
ExploRNA and the evidence needed to adopt a GMP cap reagent
A new manufacturing partnership puts supply on the agenda for mRNA teams evaluating AvantCap Q1
Sep 27
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RapidGene
Arcturus plans ARCT-2601: what carries over from ARCT-810?
The proposed formulation switch needs a clear rationale for reusing earlier development work
Sep 27
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RapidGene
FDA’s Expedited IND Pilot: A CMC Readiness Test for First-in-Human Programs
Earlier FDA feedback could be useful. The application decision starts with the work that feedback could still change.
Sep 27
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RapidGene
February 2026
FDA Grants Breakthrough Status to Neurogene’s NGN‑401 Gene Therapy: Full‑Length MECP2 Delivery Picks Up Speed
A one‑and‑done AAV gene therapy for Rett syndrome—innovation in transgene regulation meets regulatory privilege.
Feb 28
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RapidGene
BioNTech’s TNBC Neoantigen mRNA: Big T Cells, Small Timelines
Nature reports durable T-cell immunity in 14 patients — but a 69-day average sequencing-to-release clock is the real product killer.
Feb 19
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RapidGene
1
Moderna’s Flu Filing Whiplash: FDA Accepts Amended mRNA-1010 BLA—The Real Cost Moves to Post-Marketing
This isn’t “science winning”—it’s regulatory risk reallocation.
Feb 18
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RapidGene
1
EU Greenlights Moderna’s mNEXSPIKE: Same Vaccine Category, Smaller mRNA Payload, Lower Dose
This isn’t a delivery revolution—it’s a pragmatic industrial optimization: truncate the antigen, cut the dose, and buy back capacity, tolerability, and…
Feb 18
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RapidGene
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