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A minireview distinguishes bulk encapsulation efficiency from particle occupancy and RNA copy-number distributions. High encapsulation efficiency can coexist with RNA-negative particles, and process changes may alter loading without changing average size. The author cautions that eliminating empty particles does not necessarily improve activity; product-specific evidence must establish whether occupancy is a critical quality attribute.
Acuitas summarized World Vaccine Congress Europe data showing enhanced mRNA vaccine immune responses with ALC-315 in animal tumor models, alongside improved potency of newer lipids in an influenza vaccine model. The release describes preclinical tumor, survival, and immune-response findings. These results should not be read as demonstrated clinical efficacy or a human safety advantage.
Researchers combined terahertz spectroscopy, Born–Oppenheimer molecular dynamics, and interpretable deep learning to monitor salt formation in an 8-hydroxyquinolinium salicylate model system. Measurements across 80–300 K helped assign lattice-vibration features and establish a stage-resolved analytical workflow. The study is a model-system demonstration of process monitoring, rather than evidence of deployment across commercial active pharmaceutical ingredient processes.
Cosette announced FDA approval of EVOXAC cevimeline hydrochloride oral solution for dry-mouth symptoms in adults with Sjögren’s disease. The liquid formulation offers an alternative for patients who have difficulty swallowing capsules. Developed internally, it used an application pathway relying partly on existing capsule safety and efficacy data, with U.S. commercial availability expected by the end of 2026.
A mouse study compared LNP-delivered self-amplifying RNA and an Ad5 vaccine encoding the same RSV prefusion F antigen. Intramuscular dosing produced distinct immune patterns: saRNA favored pulmonary mucosal and tissue-resident memory responses, while Ad5 generated stronger systemic responses. The comparison concerns immune architecture, not demonstrated superiority in human protection.
Ascletis reported that ASC36o, an oral amylin receptor agonist tablet, had an approximately seven-day half-life and 6%–8% oral bioavailability in nonhuman primates. The company said a US Phase 1 study was underway, with human PK results expected by year-end 2026. The quantitative findings are preclinical and do not yet establish once-weekly oral dosing in humans.
Researchers separated the effects of circular structure, preparation quality, and nucleotide modification across two vaccine antigen systems. Cleaner circular RNA preparations caused less innate immune activation, but antibody and T-cell response levels were comparable with linear mRNA. Incorporating m6A was associated with higher antibody avidity, rather than a general increase in expression.
Researchers screened PEG-free hybrid particles containing a polylactic acid core and engineered lipid surface. A lead formulation preserved particle size and reporter activity after vibrating-mesh nebulization, outperforming the tested SM-102 reference under those conditions. Non-nebulized particles also transfected organoids and primary airway cultures. The authors identify mucus transport, aerosol deposition, and in vivo efficacy as unresolved next steps.
A laboratory study compared single-stage and two-stage MSMPR crystallization for paracetamol Form I and carbamazepine Form III at matched total active volume and residence time. Staging improved particle uniformity, reduced fouling, and shortened filtration times while preserving solid-state and chemical quality. The findings attribute the benefit to supersaturation distribution rather than additional crystallizer capacity.
Recipharm has added a sterile cream and ointment line at its Odivelas site in Portugal. The line accommodates aluminum and polyfoil tubes from 3.5 to 30 grams, with annual output of 8 million to 15 million units depending on fill volume and batch size. It complements existing multidose ophthalmic manufacturing and is ready for new customer projects.
Researchers developed HighPlay3 to balance cyclic peptide target binding and membrane permeability through iterative structural assessment and prediction. Experimental screening produced micromolar binders against MDM2 and GABARAP. Among tested active GABARAP candidates, GAB-D4 showed the highest Caco-2 apparent permeability with no apparent net efflux. These are early laboratory results, not demonstrated human oral bioavailability.
Serial blood samples from 73 vaccine recipients were analyzed using ddPCR for total and long-range-linked mRNA and LC-MS for ionizable lipids. RNA and lipid decay differed across three vaccine platforms. Cohorts differed in dose, vaccination history, and sampling schedules. Detecting circulating RNA fragments does not by itself establish continued protein expression, clinical toxicity, or comparative vaccine effectiveness.
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