Биофармацевтика расширенная
Расширенный coverage-пакет QC-утилит для mAb, биоаналогов, белков, инсулинов, вакцин, mRNA/LNP, HCP, стерильного выпуска, микробиологии, воды, cleanroom и стабильности.
149 Утилиты
Therapeutic / Biopharma
Biopharmaceuticals BiopharmaExtended Biologics Biosimilars mAbs Recombinant proteins
Почему выбирают FUZKK
✓ Меньше Excel-рисков
Детерминированные расчёты и проверки правил вместо неконтролируемых таблиц.
🔍 Готовность к аудиту
Расширенный пакет показывает более широкое покрытие биофармацевтической экспертизы: от аналитической характеристики и product-specific checks до стерильного выпуска, микробиологии, HCP, viral safety и cleanroom workflows.
⏱ 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 → Биофармацевтика расширенная → output.json → QA approval / audit trail
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| AAS_Elemental_Impurities_Class2B | AAS/ICP-MS Elemental Impurities Class 2B | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, AAS / elemental impurities | Lumex QC URS & FS input.csv | |
| AdalimumabQualityChecker | Adalimumab | Global API | API assay biologics biosimilars | |
| AdjuvantAdsorptionEfficiency_QualityChecker | Adjuvant Adsorption Efficiency | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| AdjuvantAluminumAssayChecker | Adjuvant Aluminum Assay | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| AdjuvantAluminumContentAndFixation_QualityChecker | Adjuvant Aluminum Content And Fixation | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| AfliberceptQualityChecker | Aflibercept | Global API | API assay biologics biosimilars | |
| AlbuminHumanQualityChecker | Albumin Human | Global API expansion | antivirals API biologics endotoxins | |
| AlemtuzumabQualityChecker | Alemtuzumab | Global API expansion | antivirals API biologics endotoxins | |
| AssayImpurityHPLCQualityChecker | Assay & Impurity HPLC | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| AssayTransferProtocolChecker | Assay Transfer Protocol | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| AtezolizumabQualityChecker | Atezolizumab | Global API expansion | antivirals API biologics endotoxins | |
| AutomatedLiquidHandlingQCQualityChecker | Automated Liquid Handling QC | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| AutomatedSterilityDetectionQualityChecker | Automated Sterility Detection | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| BacterialEndotoxinAndSterilityCombined_QualityChecker | Bacterial Endotoxin & Sterility Combined | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| BacterialEndotoxinsLALQualityChecker | Bacterial Endotoxins LAL | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| BacterialEndotoxinsRecombinantQualityChecker | Bacterial Endotoxins Recombinant | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| BatchReleaseJsonBuilder | Batch Release Json Builder | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| BenralizumabQualityChecker | Benralizumab | Global API expansion | antivirals API biologics endotoxins | |
| BevacizumabQualityChecker | Bevacizumab | Global API | API assay biologics biosimilars | |
| BiologicAggregateSizeQualityChecker | Biologic Aggregate Size | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| BiopharmaStudySampleChecker | Biopharma Study Sample | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| Capillary_ID_Aprotinin | Capillary ID Aprotinin | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis | Lumex QC URS & FS input.csv | |
| CE_DNA_Vaccine_Purity_Checker | CE DNA Vaccine Purity Checker | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis | Lumex QC URS & FS input.csv | |
| CE_Erythropoietin_Isoform_Checker | CE Erythropoietin Isoform Checker | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis | Lumex QC URS & FS input.csv | |
| CE_Glycosylation_Profiler | CE Glycosylation Profiler | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis, Capillary electrophoresis / CE QC | Lumex QC URS & FS input.csv | |
| CE_mAb_Aggregates_Fragments | CE mAb Aggregates & Fragments | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis, Capillary electrophoresis / CE QC | Lumex QC URS & FS input.csv | |
| CE_mAb_Charge_Variant_Checker | CE mAb Charge Variant Checker | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis | Lumex QC URS & FS input.csv | |
| CE_Peptide_Map_Fingerprint | CE Peptide Map Fingerprint | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis, Capillary electrophoresis / CE QC | Lumex QC URS & FS input.csv | |
| CE_Peptide_Map_Validator | CE Peptide Map Validator | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis | Lumex QC URS & FS input.csv | |
| CE_Recombinant_Protein_Purity | CE Recombinant Protein Purity | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis | Lumex QC URS & FS input.csv | |
| CetuximabQualityChecker | Cetuximab | Global API expansion | antivirals API biologics endotoxins | |
| ChargeVariantCEQualityChecker | Charge Variant CE | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ChondroitinSulfateAssayChecker | Chondroitin Sulfate Assay Checker | Pharmaceutical QC, Lumex, Biologics QC, Complex molecules, Biologics / complex molecules | Lumex QC URS & FS input.csv | |
| CircularDichroismBiologicQualityChecker | Circular Dichroism Biologic | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ClinicalTrialBatchSummaryBuilder | Clinical Trial Batch Summary Builder | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| ColdChainShippingTemperatureAndMKT_QualityChecker | Cold Chain Shipping Temperature And MKT | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| CollagenHydrolysatePeptideProfileChecker | Collagen Hydrolysate Peptide Profile Checker | Pharmaceutical QC, Lumex, Biologics QC, Complex molecules, Biologics / complex molecules | Lumex QC URS & FS input.csv | |
| ConjugateVaccinePolysaccharideProteinRatio_QualityChecker | Conjugate Vaccine Polysaccharide/Protein Ratio | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| DaptomycinQualityChecker | Daptomycin | Global API expansion | antibiotics antivirals API biologics | |
| DaratumumabQualityChecker | Daratumumab | Global API expansion | antivirals API biologics endotoxins | |
| DenosumabQualityChecker | Denosumab | Global API | API assay biologics biosimilars | |
| dsRNAContamination_mRNAVaccine_QualityChecker | dsRNA Contamination mRNA Vaccine | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| DulaglutideQualityChecker | Dulaglutide | Global API expansion | antivirals API biologics endotoxins | |
| DupilumabQualityChecker | Dupilumab | Global API expansion | antivirals API biologics endotoxins | |
| DurvalumabQualityChecker | Durvalumab | Global API expansion | antivirals API biologics endotoxins | |
| ElementalImpuritiesICPQualityChecker | Elemental Impurities ICP | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ELISABioassayQualityChecker | ELISA Bioassay | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ELISA_SpecificProteinChecker | ELISA Specific Protein | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| EndotoxinBiologicProductQualityChecker | Endotoxin Biologic Product | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| EnvironmentalMonitoringCleanroomQualityChecker | Environmental Monitoring Cleanroom | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| EpoetinAlfaQualityChecker | Epoetin Alfa | Global API | API assay biologics biosimilars | |
| EpoetinBetaQualityChecker | Epoetin Beta | Global API | API assay biologics biosimilars | |
| EtanerceptQualityChecker | Etanercept | Global API | API assay biologics biosimilars | |
| ExenatideQualityChecker | Exenatide | Global API expansion | antivirals API biologics endotoxins | |
| FilgrastimQualityChecker | Filgrastim | Global API | API assay biologics biosimilars | |
| FilterIntegrityTestQualityChecker | Filter Integrity Test | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| Fluorat_Aluminum_Vaccines | Fluorat Aluminum Vaccines | Pharmaceutical QC, Lumex, Instrumental analysis, Fluorescence, Fluorescence / Fluorat methods | Lumex QC URS & FS input.csv | |
| Fluorat_Enzyme_Fluorogenic_Assays | Fluorat Enzyme Fluorogenic Assays | Pharmaceutical QC, Lumex, Instrumental analysis, Fluorimetry, Fluorat / fluorimetry | Lumex QC URS & FS input.csv | |
| Fluorat_Nucleic_Acids_Quantifier | Fluorat Nucleic Acids Quantifier | Pharmaceutical QC, Lumex, Instrumental analysis, Fluorimetry, Fluorat / fluorimetry | Lumex QC URS & FS input.csv | |
| Fluorat_Reactive_Oxygen_Species | Fluorat Reactive Oxygen Species | Pharmaceutical QC, Lumex, Instrumental analysis, Fluorimetry, Fluorat / fluorimetry | Lumex QC URS & FS input.csv | |
| FluorescenceSpectroscopyQualityChecker | Fluorescence Spectroscopy | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| FTIRIdentityQualityChecker | FTIR Identity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| GCMSScreeningVolatileImpuritiesQualityChecker | GC-MS Screening Volatile Impurities | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| GlucagonQualityChecker | Glucagon | Global API expansion | antivirals API biologics endotoxins | |
| GolimumabQualityChecker | Golimumab | Global API expansion | antivirals API biologics endotoxins | |
| HeavyMetalsLimitTestQualityChecker | Heavy Metals Limit Test | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| HeparinSodiumMolecularWeightChecker | Heparin Sodium Molecular Weight Checker | Pharmaceutical QC, Lumex, Biologics QC, Complex molecules, Biologics / complex molecules | Lumex QC URS & FS input.csv | |
| HumanInsulinQualityChecker | Human Insulin | Global API | API assay biologics biosimilars | |
| InactivatedVaccineSafetyTest_QualityChecker | Inactivated Vaccine Safety Test | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| InfliximabQualityChecker | Infliximab | BP monographs | API assay biologics British Pharmacopoeia | |
| InsulinQualityChecker | Insulin | BP monographs | API assay biologics British Pharmacopoeia | |
| InsulinAspartQualityChecker | Insulin Aspart | Global API | API assay biologics biosimilars | |
| InsulinGlargineQualityChecker | Insulin Glargine | Global API | API assay biologics biosimilars | |
| InsulinHumanHPLCChecker | Insulin Human HPLC Checker | Pharmaceutical QC, Lumex, Biologics QC, Complex molecules, Biologics / complex molecules | Lumex QC URS & FS input.csv | |
| InsulinHumanPremixQualityChecker | Insulin Human Premix | Global API, Global API expansion | antivirals API assay biologics | |
| InsulinLisproQualityChecker | Insulin Lispro | Global API | API assay biologics biosimilars | |
| Iodine124MABQualityChecker | Iodine-124 MAb | Radiopharmaceutical QC, Radiopharmaceuticals, PetRad3 | radiopharmaceuticals QC URS & FS input.csv | |
| IpilimumabQualityChecker | Ipilimumab | Global API expansion | antivirals API biologics endotoxins | |
| HyaluronicAcidMolecularWeightChecker | Iron Sucrose Complex Checker | Pharmaceutical QC, Lumex, Biologics QC, Complex molecules, Biologics / complex molecules | Lumex QC URS & FS input.csv | |
| IxekizumabQualityChecker | Ixekizumab | Global API expansion | antivirals API biologics endotoxins | |
| LabWare_CDS_Bridge_Connector | LabWare CDS Bridge Connector | Pharmaceutical QC, Lumex, General QC, Instrumental analysis, General pharmaceutical QC | Lumex QC URS & FS input.csv | |
| LCMSConfirmationQualityChecker | LC-MS Confirmation | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| LiraglutideQualityChecker | Liraglutide | Global API expansion | antivirals API biologics endotoxins | |
| LiveAttenuatedVaccineGeneticStability_QualityChecker | Live Attenuated Vaccine Genetic Stability | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| Lutetium177J591QualityChecker | Lutetium-177 J591 | Radiopharmaceutical QC, Radiopharmaceuticals, PetRad3 | radiopharmaceuticals QC URS & FS input.csv | |
| MAT_PyrogenChecker | MAT Pyrogen | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| MepolizumabQualityChecker | Mepolizumab | Global API expansion | antivirals API biologics endotoxins | |
| MicrobialEnumerationTAMCTYMCQualityChecker | Microbial Enumeration (TAMC/TYMC) | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| MicrobialIdentificationSystemQualityChecker | Microbial Identification System | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| mRNAVaccineIntegrityAndLNP_QualityChecker | mRNA Vaccine Integrity & LNP | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| NatalizumabQualityChecker | Natalizumab | Global API expansion | antivirals API biologics endotoxins | |
| NivolumabQualityChecker | Nivolumab | Global API expansion | antivirals API biologics endotoxins | |
| OcrelizumabQualityChecker | Ocrelizumab | Global API expansion | antivirals API biologics endotoxins | |
| OmalizumabQualityChecker | Omalizumab | Global API expansion | antivirals API biologics endotoxins | |
| OsmolalityQualityChecker | Osmolality | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| OsmolalityAndpH_InjectableVaccine_QualityChecker | Osmolality And pH Injectable Vaccine | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| PackageIntegrityLeakTestQualityChecker | Package Integrity & Leak Test | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| PanitumumabQualityChecker | Panitumumab | Global API expansion | antivirals API biologics endotoxins | |
| ParticleCountInjectionUSP788QualityChecker | Particle Count Injection USP <788> | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| PegfilgrastimQualityChecker | Pegfilgrastim | Global API | API assay biologics biosimilars | |
| PembrolizumabQualityChecker | Pembrolizumab | Global API expansion | antivirals API biologics endotoxins | |
| PertuzumabQualityChecker | Pertuzumab | Global API expansion | antivirals API biologics endotoxins | |
| pHConductivityWaterQualityChecker | pH & Conductivity Water | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| Polysorbate80PeroxideChecker | Polysorbate 80 Peroxide Checker | Pharmaceutical QC, Lumex, Excipients QC, Excipients / preservatives | Lumex QC URS & FS input.csv | |
| PotencyTrendAndStabilityRegression_QualityChecker | Potency Trend And Stability Regression | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| PreparativeLCFractionQualityChecker | Preparative LC Fraction | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| PreservativeContentChecker | Preservative Content | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| Preservatives_Combo_QC | Preservatives Combo QC | Pharmaceutical QC, Lumex, General QC, Instrumental analysis, General pharmaceutical QC | Lumex QC URS & FS input.csv | |
| ProteinAggregationAndSubVisibleParticles_QualityChecker | Protein Aggregation And SubVisible Particles | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| ProteinConcentrationUVQualityChecker | Protein Concentration UV | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| PyrogenTestRabbitMATQualityChecker | Pyrogen Test (Rabbit & MAT) | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| qPCR_ViralSafetyChecker | q PCR Viral Safety | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| RamanIdentityQualityChecker | Raman Identity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| RanibizumabQualityChecker | Ranibizumab | Global API | API assay biologics biosimilars | |
| RapidMicroAlternativeMethodQualityChecker | Rapid Micro Alternative Method | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| RavulizumabQualityChecker | Ravulizumab | Biopharmaceuticals / Immunology, Biopharmaceuticals, Immunology, mAb | Biopharmaceuticals Biologics mAb Ravulizumab | |
| ReagentLotVerificationChecker | Reagent Lot Verification | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| ReplicationCompetentVirus_RCV_QualityChecker | Replication Competent Virus RCV | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| ResidualFormaldehydeAndInactivant_QualityChecker | Residual Formaldehyde And Inactivant | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| ResidualHostCellDNA_QualityChecker | Residual Host Cell DNA | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| ResidualHostProteinChecker | Residual Host Protein | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| ResidualSolventsGCQualityChecker | Residual Solvents GC | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| RituximabQualityChecker | Rituximab | Global API | API assay biologics biosimilars | |
| RunSummaryJsonExporter | Run Summary JSON Exporter | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| SampleAgeAndStabilityChecker | Sample Age & Stability | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| SampleIdentityConsistencyChecker | Sample Identity Consistency | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| SamplePrepHomogenizationQualityChecker | Sample Prep Homogenization | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| SampleTransportStabilityChecker | Sample Transport Stability | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| SecukinumabQualityChecker | Secukinumab | Global API expansion | antivirals API biologics endotoxins | |
| SpecifiedMicroorganismsQualityChecker | Specified Microorganisms | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| SPRBindingAffinityQualityChecker | SPR Binding Affinity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| StabilityConditionMonitoringQualityChecker | Stability Condition Monitoring | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| Stability_Shelf_Life_Predictor | Stability Shelf Life Predictor | Pharmaceutical QC, Lumex, Stability, General QC, Stability and shelf-life modelling | Lumex QC URS & FS input.csv | |
| SterilityMycoplasmaReviewUtility | Sterility & Mycoplasma Review | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| SterilityTestMembraneFiltrationQualityChecker | Sterility Test Membrane Filtration | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| System_Suitability_Parameters_Checker | System Suitability Parameters Checker | Pharmaceutical QC, Lumex, General QC, System suitability, System suitability / chromatography QC | Lumex QC URS & FS input.csv | |
| TeriparatideQualityChecker | Teriparatide | Global API | API assay biologics biosimilars | |
| ThimerosalAndPreservativeContent_QualityChecker | Thimerosal And Preservative Content | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| TOCWaterQualityChecker | TOC Water | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| TocilizumabQualityChecker | Tocilizumab | Global API expansion | antivirals API biologics endotoxins | |
| TrastuzumabQualityChecker | Trastuzumab | Global API | API assay biologics biosimilars | |
| UstekinumabQualityChecker | Ustekinumab | Global API | API assay biologics biosimilars | |
| UVVisIdentityAssayQualityChecker | UV-Vis Identity & Assay | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| VedolizumabQualityChecker | Vedolizumab | Global API expansion | antivirals API biologics endotoxins | |
| ViscosityRheologyQualityChecker | Viscosity & Rheology | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| WaterActivityQualityChecker | Water Activity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| WaterContentKFQualityChecker | Water Content KF | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| WaterMicrobiologyQualityChecker | Water Microbiology | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| Zirconium89TrastuzumabQualityChecker | Zirconium-89 Trastuzumab | Radiopharmaceutical QC, Radiopharmaceuticals, PetRad3 | radiopharmaceuticals QC URS & FS input.csv |
Лицензирование и поддержка
Расширенный пакет рекомендуется для демонстрационного coverage mapping, переговоров с производителями биопрепаратов/CDMO и подготовки нескольких возможных пилотных контуров.