Иммунология
Пакет QC-утилит для иммунологии: моноклональные антитела, биоаналоги, иммуномодуляторы, иммуносупрессанты, ELISA/SPR, HCP, белковая характеристика, стерильность и pyrogen/release checks.
95 Утилиты
Therapeutic / Immunology / Biologics
Immunology mAb Biologics Biosimilars ELISA SPR
Почему выбирают FUZKK
✓ Меньше Excel-рисков
Детерминированные расчёты и проверки правил вместо неконтролируемых таблиц.
🔍 Готовность к аудиту
Готовность к аудиту (IQ/OQ): каждая утилита пакета поставляется с URS/FS, CSV-контрактом, JSON-выходом и структурой данных, пригодной для CSV/CSA, OQ/PQ и QA/QC review.
⏱ 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 → Иммунология → 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 | |
| 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 | |
| AntigenContentELISAReviewer | Antigen Content ELISA | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| AtezolizumabQualityChecker | Atezolizumab | Global API expansion | antivirals API biologics endotoxins | |
| AzathioprineQualityChecker | Azathioprine | BP monographs | API assay British Pharmacopoeia impurities | |
| 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 | |
| BioassayValidityChecker | Bioassay Validity | Pharmacopoeial methods | heavy metals microbiology particulate contamination Ph. Eur. | |
| BiologicAggregateSizeQualityChecker | Biologic Aggregate Size | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| BudesonideQualityChecker | Budesonide | Global API | API assay biosimilars fixed-dose combinations | |
| 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 | |
| CircularDichroismBiologicQualityChecker | Circular Dichroism Biologic | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| CyclosporineQualityChecker | Cyclosporine | Global API expansion | antivirals API biologics dissolution | |
| 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 | |
| DexamethasoneQualityChecker | Dexamethasone | BP monographs | API assay British Pharmacopoeia impurities | |
| 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 | |
| ELISAAssayPlateAcceptanceChecker | ELISA Assay Plate Acceptance | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| 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 | |
| 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 | |
| FluorescenceSpectroscopyQualityChecker | Fluorescence Spectroscopy | 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 | |
| HumanInsulinQualityChecker | Human Insulin | Global API | API assay biologics biosimilars | |
| HydrocortisoneQualityChecker | Hydrocortisone | BP monographs | API assay British Pharmacopoeia impurities | |
| ImmuneRepertoireMrdQcChecker | Immune Repertoire MRD QC | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| ImmunoglobulinsAnalyzer | Immunoglobulins Analyzer | Pharmacopoeial methods | heavy metals microbiology particulate contamination Ph. Eur. | |
| InfliximabQualityChecker | Infliximab | 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 | |
| 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 | |
| IxekizumabQualityChecker | Ixekizumab | Global API expansion | antivirals API biologics endotoxins | |
| LiraglutideQualityChecker | Liraglutide | Global API expansion | antivirals API biologics endotoxins | |
| 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 | |
| MethotrexateQualityChecker | Methotrexate | BP monographs | API assay British Pharmacopoeia impurities | |
| MethylprednisoloneQualityChecker | Methylprednisolone | BP monographs | API assay British Pharmacopoeia impurities | |
| MycophenolateMofetilQualityChecker | Mycophenolate Mofetil | Global API | API assay biologics biosimilars | |
| NatalizumabQualityChecker | Natalizumab | Global API expansion | antivirals API biologics endotoxins | |
| NivolumabQualityChecker | Nivolumab | Global API expansion | antivirals API biologics endotoxins | |
| NMRStructureQualityChecker | NMR Structure | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| OcrelizumabQualityChecker | Ocrelizumab | Global API expansion | antivirals API biologics endotoxins | |
| OmalizumabQualityChecker | Omalizumab | Global API expansion | antivirals API biologics endotoxins | |
| PanitumumabQualityChecker | Panitumumab | Global API expansion | antivirals API biologics endotoxins | |
| 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 | |
| PrednisoloneQualityChecker | Prednisolone | Global API expansion | antivirals API biologics dissolution | |
| PreservativeContentChecker | Preservative Content | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| 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 | |
| RanibizumabQualityChecker | Ranibizumab | Global API | API assay biologics biosimilars | |
| RavulizumabQualityChecker | Ravulizumab | Biopharmaceuticals / Immunology, Biopharmaceuticals, Immunology, mAb | Biopharmaceuticals Biologics mAb Ravulizumab | |
| 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 | |
| ResidualHostCellDNAqPCRChecker | Residual Host Cell DNA qPCR | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| ResidualHostProteinChecker | Residual Host Protein | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| RituximabQualityChecker | Rituximab | Global API | API assay biologics biosimilars | |
| SampleIdentityConsistencyChecker | Sample Identity Consistency | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| SecukinumabQualityChecker | Secukinumab | Global API expansion | antivirals API biologics endotoxins | |
| SirolimusQualityChecker | Sirolimus | Global API expansion | antivirals API biologics dissolution | |
| SPRBindingAffinityQualityChecker | SPR Binding Affinity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| SterilityMycoplasmaReviewUtility | Sterility & Mycoplasma Review | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| TacrolimusQualityChecker | Tacrolimus | Global API | API assay biosimilars capsules | |
| TeriparatideQualityChecker | Teriparatide | Global API | API assay biologics biosimilars | |
| 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 | |
| VedolizumabQualityChecker | Vedolizumab | Global API expansion | antivirals API biologics endotoxins | |
| Zirconium89TrastuzumabQualityChecker | Zirconium-89 Trastuzumab | Radiopharmaceutical QC, Radiopharmaceuticals, PetRad3 | radiopharmaceuticals QC URS & FS input.csv |
Лицензирование и поддержка
Лицензирование и поддержка: пакет поставляется как набор QC-утилит для одной компании или производственной площадки, с возможной поддержкой пилота, LIMS/ELN/MES-интеграции и подготовки к валидации.