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Search bilingual publication guides on delivery, in vivo CAR-T, therapeutic translation, safety, analytics, and manufacturing.
Lonza signed an agreement to acquire five US CDMO sites from Merck KGaA, adding bioconjugation, payload-linker, viral vector, and advanced delivery capabilities. Closing is expected in mid-2027, subject to customary conditions. Until then, the businesses will continue operating independently.
The DeepDelivery platform screened the human proteome for proteins that could serve as mRNA delivery scaffolds. Twelve of 15 experimentally tested candidates supported particle formation and delivery within a modular system. Engineering TRIM25 domains improved performance. The work establishes a discovery framework in cultured cells, rather than clinical evidence of reduced immunogenicity.
Lipid-polymer hybrid particles combined polymer stability with lipid-mediated transfection. Hyaluronic acid and polyvinyl alcohol coatings helped preserve particle properties after nebulization, while mucus-covered airway cultures retained measurable transfection. Primary human lung fibroblasts and intratracheally dosed mice provided additional delivery evidence. These results support aerosol formulation development, although intratracheal dosing does not establish the performance of inhaled aerosols in patients.
A post-loading method combined mRNA with preformed empty lipid nanoparticles using heat and acidic conditions, achieving roughly 90% encapsulation. The particles produced protein expression in mouse liver and spleen, although activity was slightly below conventional microfluidic formulations. Greater payload heterogeneity emerged as a potential limitation; the method supports 96-well preparation.
An experimental H5N1 mRNA-LNP vaccine was tested in eight lactating dairy cows split between vaccinated and control groups. After two doses and mammary challenge, vaccination reduced peak viral RNA in milk by about 1,000-fold and lessened mastitis and fibrosis. This small animal study does not establish field effectiveness or human protection.
Using three established ionizable lipids, researchers measured RNA, lipid components, lymphatic transport, plasma exposure, and tissue reporter expression in rats. After subcutaneous injection, lymph concentrations exceeded plasma concentrations, but lipid and RNA trafficking did not fully match. The study demonstrates why tracking a lipid label alone may not accurately represent intact RNA delivery or productive expression in tissues.
A Perspective proposes designing mRNA vaccine materials around changing immune conditions before and after cancer surgery. The framework considers a broadly applicable preoperative prime followed by a personalized postoperative boost, with carriers controlling expression and immune activation. It is a conceptual design roadmap, not evidence from a new clinical trial.
MEPSGEN has launched NanoCalibur Mini for automated formulation of lipid and polymeric nanoparticles at volumes of 0.1 to 3 milliliters. The system targets early screening when payloads and excipients are scarce. The company says its platforms retain identical microfluidic mixing geometry across scales and increase throughput through parallelization, an approach intended to reduce process redevelopment during technology transfer.
Moderna reported detailed results from the randomized, double-blind Phase 3 INTerpath-001 trial in completely resected stage IIB–IV melanoma. Adding intismeran autogene to pembrolizumab improved recurrence-free survival in the prespecified intention-to-treat analysis: hazard ratio 0.58 (95% CI 0.45–0.75), with 24.6 months median follow-up. Grade 3–5 treatment-related adverse events occurred in 14.2% versus 13.4%. The treatment remains investigational.
A ligand-free nanoparticle formulation preferentially delivered mRNA to human hematopoietic stem and progenitor cells in humanized mice without conditioning. It reduced hepatic delivery relative to an SM-102 comparator and enabled functional Cas9-mediated editing of human CD34-positive cells. Single-cell analyses supported tolerability under the conditions examined. Durable stem-cell function and clinical delivery still require further investigation.
An engineered nanoparticle delivered mRNAs encoding IL-1 receptor antagonist and an angiopoietin-like 3 derivative through intra-articular injection. The combination addressed inflammation and cartilage degeneration in several mouse arthritis models, with transcriptomic analyses supporting complementary biological effects. These findings broaden local mRNA therapy beyond vaccination, but durable structural benefit, repeated-dose safety, and effectiveness in human joints remain unproven.
Biomay introduced a personalized cancer-vaccine manufacturing service, reporting an approximately three-week mRNA workflow from starting material through quality release. The process covers template DNA, transcription, LNP manufacturing, testing, and qualified-person release, supported by in-house analytics and dedicated suites. Biomay cited experience releasing more than 120 personalized GMP batches. Timelines and capacity claims are supplier-reported and require program-specific confirmation.
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