Biopharmaceuticals Core QC Suite
Focused QC utility package for biologic products: HCP, mAbs, biosimilars, proteins/peptides, sterility, endotoxins and key release checks.
61 Utilities
Therapeutic / Biopharma
Biopharmaceuticals BiopharmaCore Biologics Biosimilars HCP mAb
Why FUZKK utilities
✓ Fewer Excel risks
Deterministic calculation and rule checks instead of uncontrolled spreadsheets.
🔍 Audit readiness
The core biopharmaceutical package is suitable for an initial QC pilot: a focused set of existing utilities, clear CSV input, reproducible checks and JSON output for QA/QC review.
⏱ Laboratory time
Faster data checks, batch review and structured JSON output for downstream systems.
🚀 Integration
Designed for CSV, LIMS/ELN/MES and validated laboratory workflows.
Integration workflow
Instrument / LIMS / ELN / MES → input.csv → Biopharmaceuticals Core QC Suite → output.json → QA approval / audit trail
Utilities in this package
| Utility | API / Monograph | Categories | Tags | |
|---|---|---|---|---|
| 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 | |
| AlemtuzumabQualityChecker | Alemtuzumab | Global API expansion | antivirals API biologics endotoxins | |
| AtezolizumabQualityChecker | Atezolizumab | Global API expansion | antivirals API biologics endotoxins | |
| 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 | |
| CetuximabQualityChecker | Cetuximab | Global API expansion | antivirals API biologics endotoxins | |
| CircularDichroismBiologicQualityChecker | Circular Dichroism Biologic | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| PreservativeContentChecker | Preservative Content | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| 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 | |
| ResidualHostProteinChecker | Residual Host Protein | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| RituximabQualityChecker | Rituximab | Global API | API assay biologics biosimilars | |
| SecukinumabQualityChecker | Secukinumab | Global API expansion | antivirals API biologics endotoxins | |
| 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 | |
| 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 |
Licensing and support
The package can be delivered as part of FUZKK Portal or as a limited pilot set for one site/QC team. Product limits and SOP interpretation remain client-specific.