mRNA/LNP качество
mRNA/LNP качество: пакет утилит FUZKK для CSV→JSON QC-проверок с EU-first приоритетом лимитов.
16 Утилиты
FUZKK utility packages
advanced-pharma EU-first CSV→JSON LabWare no-api-package
Почему выбирают FUZKK
✓ Меньше Excel-рисков
Детерминированные расчёты и проверки правил вместо неконтролируемых таблиц.
🔍 Готовность к аудиту
Пакет содержит автономные CSV→JSON QC-утилиты FUZKK. Каждая утилита имеет встроенное самоописание, пример input.csv, demo-evaluation и LabWare-compatible JSON output.
⏱ Время лаборатории
Более быстрая проверка данных, ревью партии и структурированный JSON-результат для последующих систем.
🚀 Интеграция
Подходит для CSV, LIMS/ELN/MES и валидируемых лабораторных процессов.
Схема интеграции
Instrument / LIMS / ELN / MES → input.csv → mRNA/LNP качество → output.json → QA approval / audit trail
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| LNP_Encapsulation_Efficiency_Analyzer | LNP Encapsulation Efficiency Analyzer | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| LNP_ParticleSize_PDI_Monitor | LNP Particle Size PDI Monitor | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| LNPCriticalQualityAttributeChecker | LNPCritical Quality Attribute Checker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| LNPEncapsulationEfficiencyChecker | LNPEncapsulation Efficiency Checker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| LNPParticleSizePDIChecker | LNPParticle Size PDIChecker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| LNPZetaPotentialChecker | LNPZeta Potential Checker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNA_Cap_PolyA_Integrity_Checker | m RNA Cap Poly A Integrity Checker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNA_LNP_ColdChain_Stability_Tracker | m RNA LNP Cold Chain Stability Tracker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNA_LNP_Potency_Bioassay_Reviewer | m RNA LNP Potency Bioassay Reviewer | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNA_Residual_dsRNA_Quantifier | m RNA Residual ds RNA Quantifier | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNACapPolyAIntegrityChecker | m RNACap Poly AIntegrity Checker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNAColdChainStabilityTrendChecker | m RNACold Chain Stability Trend Checker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNAPotencyAssayChecker | m RNAPotency Assay Checker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNAResidualDNAProteinChecker | m RNAResidual DNAProtein Checker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNAResidualDsRNAChecker | m RNAResidual Ds RNAChecker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare | |
| mRNASterilityEndotoxinReleaseChecker | m RNASterility Endotoxin Release Checker | Advanced Pharma / MRNALNPQuality Suite, pharma, FUZKK backlog 2026 | AdvancedPharma CSV→JSON EU-first LabWare |
Лицензирование и поддержка
Поставка as-is на юридическое лицо без права перепродажи. Валидация, CSV/URS/FS review и внедрение в LIMS выполняются на стороне заказчика или отдельным проектом.