Immunology QC Suite: QC Utility Fit Map

Standard article for the Immunology QC Suite package: 94 existing FUZKK utilities grouped by QC workflows. Added RavulizumabQualityChecker for complement C5 inhibitor / mAb workflow.

Immunology QC Suite: QC Utility Fit Map

This package highlights existing FUZKK utilities for immunology: mAbs, biosimilars, immunomodulators, immunosuppressants, ELISA/SPR, HCP, protein characterization and biologic-release workflows.

Standard article for a new FUZKK portal package. The mapping uses existing utility IDs only; no new utility DTOs are added by this JSON.

Utilities

Coverage groups

Type

Pre-Proposal Fit Map

The package does not claim that every utility is required for every manufacturer. It is a pre-proposal utility fit map: an initial map of existing deterministic FUZKK QC tools that may be relevant for this domain.

Coverage groups

Biologic safety and release controlsGeneral analytical releaseImmunoassay and protein characterizationImmunosuppressants and anti-inflammatory productsmAbs, biologics and biosimilars

Utility list

Group	Utility	Fit
General analytical release	AAS_Elemental_Impurities_Class2B	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Adalimumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Aflibercept Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Alemtuzumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Atezolizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Benralizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Bevacizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Biologic Aggregate Size Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Cetuximab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Circular Dichroism Biologic Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Daptomycin Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Daratumumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Denosumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Dulaglutide Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Dupilumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Durvalumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	ELISA Specific Protein Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Epoetin Alfa Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Epoetin Beta Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Etanercept Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Exenatide Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Filgrastim Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Glucagon Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Golimumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Human Insulin Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Insulin Aspart Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Insulin Glargine Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Insulin Human Premix Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Insulin Lispro Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Iodine124 MAB Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Ipilimumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Ixekizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Liraglutide Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Lutetium177 J591 Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Biologic safety and release controls	MAT Pyrogen Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Mepolizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Natalizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Nivolumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Ocrelizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Omalizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Panitumumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Pegfilgrastim Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Pembrolizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Pertuzumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Preservative Content Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Biologic safety and release controls	Pyrogen Test (Rabbit & MAT) Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Biologic safety and release controls	q PCR Viral Safety Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Ranibizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Residual Formaldehyde And Inactivant Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Residual Host Protein Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Rituximab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Secukinumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	SPR Binding Affinity Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Biologic safety and release controls	Sterility & Mycoplasma Review Utility	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Teriparatide Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Tocilizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Trastuzumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Ustekinumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Vedolizumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Zirconium89 Trastuzumab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	Infliximab Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	CE_mAb_Aggregates_Fragments	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
mAbs, biologics and biosimilars	CE_mAb_Charge_Variant_Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	CE_Glycosylation_Profiler	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	CE_Peptide_Map_Fingerprint	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	CE_Peptide_Map_Validator	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	CE_Recombinant_Protein_Purity	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Charge Variant CE Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	ELISA Assay Plate Acceptance Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	ELISA Bioassay Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Antigen Content ELISA Reviewer	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Immunoglobulins Analyzer	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Residual Host Cell DNA Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Residual Host Cell DNA qPCR Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Protein Aggregation And SubVisible Particles Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Bioassay Validity Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunoassay and protein characterization	Protein Concentration UV Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	Fluorescence Spectroscopy Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
General analytical release	NMR Structure Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
Immunosuppressants and anti-inflammatory products	Cyclosporine Quality Checker	Existing deterministic QC utility mapped to immunology, biologics, mAb, immunoassay or biologic-release workflows.
+ 14 additional mapped utilities are included in the package metadata and utility table.

Why choose FUZKK Utilities?

✅ Replace Excel

No hidden formulas or accidental edits. Deterministic logic, version control and reproducible results.

🔍 Audit-ready (IQ/OQ)

Each utility is supplied with URS & FS templates. This accelerates validation preparation and inspections.

⏱ Save QC time

Automate checks, calculations and reporting. The team focuses on deviations and scientific assessment rather than formatting.

🚀 Fast deployment

CSV input and JSON output allow integration without building heavy custom LIMS modules from scratch.

Integration workflow

LIMS / ELN / CSV export → FUZKK utility → output.json → QMS / eDMS / batch release

The utilities read CSV input and generate structured JSON output suitable for automated batch release, QA/QC review and LIMS/ELN/MES integration.

Utilities and checked parameters

#	API / product	Utility	Key checks
1	AAS/ICP-MS Elemental Impurities Class 2B	`aas elemental impurities class2 b`	Utility description: AAS/ICP-MS Elemental Impurities Class 2B AAS/ICP-MS Elemental Impurities Class 2B — Class 2B Elements Control (ICH Q3D) ℹ️ Utility checks 14 Class 2B elements according to ICH Q3D: • Thallium (Tl) ≤0…
2	Adalimumab	`adalimumab`	Adalimumab Quality Checker — Biologic Drug (Monoclonal Antibody) (Ph.
3	Aflibercept	`aflibercept`	Aflibercept Quality Checker — Biologic Drug (Recombinant Fusion Protein) (Ph.
4	Alemtuzumab	`alemtuzumab`	Alemtuzumab Quality Checker — Biologic Drug (Anti-CD52 mAb) (Ph.
5	Atezolizumab	`atezolizumab`	Atezolizumab Quality Checker — Biologic Drug (Anti-PD-L1 mAb) (Ph.
6	Benralizumab	`benralizumab`	Benralizumab Quality Checker — Biologic Drug (Anti-IL-5Rα mAb) (Ph.
7	Bevacizumab	`bevacizumab`	Bevacizumab Quality Checker — Biologic Drug (Monoclonal Antibody) (Ph.
8	Biologic Aggregate Size	`biologic aggregate size`	Biologic Aggregate Size Quality Checker — Control of Aggregation and Particle Size of Biologics ℹ️ Utility checks critical quality parameters of biological products: • HMW Aggregates (High Molecular Weight): ≤1.
9	Cetuximab	`cetuximab`	Cetuximab Quality Checker — Biologic Drug (Anti-EGFR mAb) (Ph.
10	Circular Dichroism Biologic	`circular dichroism biologic`	Circular Dichroism Biologic Quality Checker — Control of Biologic Structure (CD) ℹ️ Utility checks critical parameters of protein molecule conformation: • Secondary structure (ellipticity at 222 nm): within ±10% of refer…
11	Daptomycin	`daptomycin`	Daptomycin Quality Checker — Lipopeptide Antibiotic (Ph. Eur., USP) ℹ️ The utility checks A10 content, peptide profile, sterility, endotoxins, particulates. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CR…
12	Daratumumab	`daratumumab`	Daratumumab Quality Checker — Biologic Drug (Anti-CD38 mAb) (Ph.
13	Denosumab	`denosumab`	Denosumab Quality Checker — Biologic Drug (Monoclonal Antibody) (Ph.
14	Dulaglutide	`dulaglutide`	Dulaglutide Quality Checker — Biologic Drug (GLP-1 Analog) (Ph.
15	Dupilumab	`dupilumab`	Dupilumab Quality Checker — Biologic Drug (Anti-IL-4Rα mAb) (Ph.
16	Durvalumab	`durvalumab`	Durvalumab Quality Checker — Biologic Drug (Anti-PD-L1 mAb) (Ph.
17	ELISA Specific Protein	`elisa specific protein checker`	ELISA Specific Protein Checker — Protein content verification (ICH Q6B) ℹ️ The utility verifies ELISA results: API, HCP, aggregates in biologics.
18	Epoetin Alfa	`epoetin alfa`	Epoetin Alfa Quality Checker — Biologic Drug (Erythropoietin) (Ph.
19	Epoetin Beta	`epoetin beta`	Epoetin Beta Quality Checker — Biologic Drug (Erythropoietin Beta) (Ph.
20	Etanercept	`etanercept`	Etanercept Quality Checker — Biologic Drug (TNF-Receptor Fusion Protein) (Ph.
21	Exenatide	`exenatide`	Exenatide Quality Checker — Biologic Drug (GLP-1 Analog) (Ph.
22	Filgrastim	`filgrastim`	Filgrastim Quality Checker — Biologic Drug (G-CSF) (Ph. Eur., USP, ICH Q6B) ℹ️ The utility checks specific activity, Met oxidation, aggregates, HCP (E.coli), DNA, sterility. ℹ️ Does not use machine learning — rule-based…
23	Glucagon	`glucagon`	Glucagon Quality Checker — Biologic Drug (Peptide Hormone) (Ph.
24	Golimumab	`golimumab`	Golimumab Quality Checker — Biologic Drug (Anti-TNF-a mAb) (Ph.
25	Human Insulin	`human insulin`	Human Insulin Quality Checker — Biologic Drug (Peptide Hormone) (Ph.
26	Insulin Aspart	`insulin aspart`	Insulin Aspart Quality Checker — Biologic Drug (Insulin Analog) (Ph.
27	Insulin Glargine	`insulin glargine`	Insulin Glargine Quality Checker — Biologic Drug (Long-acting Insulin Analog) (Ph.
28	Insulin Human Premix	`insulin human premix`	Insulin Human Premix Quality Checker — Biologic Drug (NPH+Soluble Mix) (Ph.
29	Insulin Lispro	`insulin lispro`	Insulin Lispro Quality Checker — Biologic Drug (Rapid-acting Insulin Analog) (Ph.
30	Iodine-124 MAb	`iodine124 mab`	Iodine-124 MAb Quality Checker — Iodine-124 Monoclonal Antibodies (ImmunoPET) ℹ️ Utility checks critical parameters of Iodine-124 labeled monoclonal antibodies: • Radiochemical purity (≥90%) • Free Iodine-124 impurity (≤…
31	Ipilimumab	`ipilimumab`	Ipilimumab Quality Checker — Biologic Drug (Anti-CTLA-4 mAb) (Ph.
32	Ixekizumab	`ixekizumab`	Ixekizumab Quality Checker — Biologic Drug (Anti-IL-17A mAb) (Ph.
33	Liraglutide	`liraglutide`	Liraglutide Quality Checker — Biologic Drug (GLP-1 Analog) (Ph.
34	Lutetium-177 J591	`lutetium177 j591`	Lutetium-177 J591 Quality Checker — Lutetium-177 J591 (Anti-PSMA mAb) for prostate cancer therapy ℹ️ Utility checks critical parameters of Lutetium-177 J591: • Radionuclidic purity (≥99.
35	MAT Pyrogen	`mat pyrogen checker`	MAT Pyrogen Checker — Pyrogenicity assessment via Monocyte Activation Test (Ph.
36	Mepolizumab	`mepolizumab`	Mepolizumab Quality Checker — Biologic Drug (Anti-IL-5 mAb) (Ph.
37	Natalizumab	`natalizumab`	Natalizumab Quality Checker — Biologic Drug (Anti-Alpha-4 Integrin mAb) (Ph.
38	Nivolumab	`nivolumab`	Nivolumab Quality Checker — Biologic Drug (Anti-PD-1 mAb) (Ph.
39	Ocrelizumab	`ocrelizumab`	Ocrelizumab Quality Checker — Biologic Drug (Anti-CD20 mAb) (Ph.
40	Omalizumab	`omalizumab`	Omalizumab Quality Checker — Biologic Drug (Anti-IgE mAb) (Ph.
41	Panitumumab	`panitumumab`	Panitumumab Quality Checker — Biologic Drug (Anti-EGFR mAb) (Ph.
42	Pegfilgrastim	`pegfilgrastim`	Pegfilgrastim Quality Checker — Biologic Drug (Pegylated G-CSF) (Ph.
43	Pembrolizumab	`pembrolizumab`	Pembrolizumab Quality Checker — Biologic Drug (Anti-PD-1 mAb) (Ph.
44	Pertuzumab	`pertuzumab`	Pertuzumab Quality Checker — Biologic Drug (Anti-HER2 mAb) (Ph.
45	Preservative Content	`preservative content checker`	Preservative Content Checker — Control of Preservative Content ℹ️ Utility assesses quantitative content of antimicrobial preservatives in multi-dose dosage forms (eye drops, injections, nasal sprays) according to Ph.
46	Pyrogen Test (Rabbit & MAT)	`pyrogen test rabbit matquality checker`	Pyrogen Test (Rabbit & MAT) Quality Checker — Control of Pyrogenicity ℹ️ Utility checks pyrogen test results according to USP and Ph.
47	q PCR Viral Safety	`q pcr viral safety checker`	qPCR Viral Safety Checker — qPCR assay validation and interpretation (Ph.
48	Ranibizumab	`ranibizumab`	Ranibizumab Quality Checker — Biologic Drug (Anti-VEGF Fab fragment) (Ph.
49	Residual Formaldehyde And Inactivant	`residual formaldehyde and inactivant`	Residual Formaldehyde And Inactivant Quality Checker — Residual Inactivant Control ℹ️ Utility performs quality control of inactivated vaccines, determining levels of residual chemical agents according to WHO TRS 978 and…
50	Residual Host Protein	`residual host protein checker`	Residual Host Protein Checker — Host Cell Protein (HCP) verification ℹ️ The utility verifies HCP levels in biologics (mAbs, recombinant proteins).
51	Rituximab	`rituximab`	Rituximab Quality Checker — Biologic Drug (Anti-CD20 mAb) (Ph.
52	Secukinumab	`secukinumab`	Secukinumab Quality Checker — Biologic Drug (Anti-IL-17A mAb) (Ph.
53	SPR Binding Affinity	`sprbinding affinity`	SPR Binding Affinity Quality Checker — Control of Binding Affinity (SPR) ℹ️ Utility assesses the kinetics of interaction of biological products (e.
54	Sterility & Mycoplasma Review	`sterility mycoplasma review utility`	Sterility & Mycoplasma Review Utility — Review of Sterility and Mycoplasma Tests ℹ️ Utility performs comprehensive verification of microbiological test results for biotechnological products according to Ph.
55	Teriparatide	`teriparatide`	Teriparatide Quality Checker — Biologic Drug (Parathyroid Hormone) (Ph.
56	Tocilizumab	`tocilizumab`	Tocilizumab Quality Checker — Biologic Drug (Anti-IL-6R mAb) (Ph.
57	Trastuzumab	`trastuzumab`	Trastuzumab Quality Checker — Biologic Drug (Anti-HER2 mAb) (Ph.
58	Ustekinumab	`ustekinumab`	Ustekinumab Quality Checker — Biologic Drug (Anti-IL-12/23 mAb) (Ph.
59	Vedolizumab	`vedolizumab`	Vedolizumab Quality Checker — Biologic Drug (Anti-Integrin mAb) (Ph.
60	Zirconium-89 Trastuzumab	`zirconium89 trastuzumab`	Zirconium-89 Trastuzumab Quality Checker — Zirconium-89 Trastuzumab for HER2-PET ℹ️ Utility checks critical parameters of Zr-89-Trastuzumab: • Immunoreactivity (≥80%) — MAIN PARAMETER!
61	Infliximab	`infliximab`	Infliximab Quality Checker — Infliximab quality assessment (BP/Ph.
62	CE mAb Aggregates & Fragments	`ce m ab aggregates fragments`	Utility description: CE mAb Aggregates & Fragments CE mAb Aggregates & Fragments — Control of mAb Aggregates and Fragments (CE-SDS) ℹ️ Utility checks critical purity parameters of monoclonal antibodies: • Aggregates (Hig…
63	CE mAb Charge Variant Checker	`ce m ab charge variant checker`	Utility description: CE mAb Charge Variant Checker CE mAb Charge Variant Checker — Monoclonal Antibody Charge Variant Analysis (CE/CIEF) ℹ️ Utility checks charge heterogeneity of monoclonal antibodies: • Acidic variants…
64	CE Glycosylation Profiler	`ce glycosylation profiler`	Utility description: CE Glycosylation Profiler CE Glycosylation Profiler — Analysis of Protein Glycosylation Profile (CE) ℹ️ Utility checks critical parameters of recombinant protein glycosylation: • Asialo forms: ≤5.
65	CE Peptide Map Fingerprint	`ce peptide map fingerprint`	Utility description: CE Peptide Map Fingerprint CE Peptide Map Fingerprint — Peptide Mapping of Proteins (CE) ℹ️ Utility checks critical parameters of recombinant protein peptide maps: • Peak Count: ≥20 (depends on prote…
66	CE Peptide Map Validator	`ce peptide map validator`	Utility description: CE Peptide Map Validator CE Peptide Map Validator — Peptide Mapping Validation (CE/HPLC) ℹ️ Utility compares sample peptide map with reference: • Sequence coverage ≥95.
67	CE Recombinant Protein Purity	`ce recombinant protein purity`	Utility description: CE Recombinant Protein Purity CE Recombinant Protein Purity — Recombinant Protein Purity Control (SDS-CE) ℹ️ Utility checks electrophoretic purity of protein under denaturing conditions: • Main Band…
68	Charge Variant CE	`charge variant cequality checker`	Charge Variant CE Quality Checker — Analysis of Monoclonal Antibody Charge Variants (CE-cIEF) ℹ️ Utility checks critical parameters of charge variant distribution: • Acidic Variants: ≤15.
69	ELISA Assay Plate Acceptance	`elisa assay plate acceptance checker`	ELISA Assay Plate Acceptance Checker — ELISA Plate Acceptance Verification ℹ️ Utility performs automatic verification of System Suitability criteria for Enzyme-Linked Immunosorbent Assay (ELISA) according to FDA/EMA guid…
70	ELISA Bioassay	`elisabioassay`	ELISA Bioassay Quality Checker — Control of ELISA Quality ℹ️ Utility checks critical parameters of ELISA validity: • Calibration Curve Linearity (R²): ≥0.
71	Antigen Content ELISA	`antigen content elisa reviewer`	Antigen Content ELISA Reviewer — Quantitative ELISA Results Review ℹ️ Utility performs automatic verification of acceptance criteria for Enzyme-Linked Immunosorbent Assay (ELISA) for antigen quantification according to U…
72	Immunoglobulins Analyzer	`immunoglobulins analyzer`	Immunoglobulins Analyzer — Анализ активности иммуноглобулинов (Ph.
73	Residual Host Cell DNA	`residual host cell dna`	Residual Host Cell DNA Quality Checker — Control of Residual Host Cell DNA (qPCR) ℹ️ Utility assesses residual host cell DNA content in recombinant and culture-based vaccines according to WHO and FDA guidelines: • Critic…
74	Residual Host Cell DNA qPCR	`residual host cell dn aq pcr checker`	Residual Host Cell DNA qPCR Checker — Control of Residual Host Cell DNA (qPCR) ℹ️ Utility assesses residual host cell DNA content in recombinant and culture-based products according to WHO and FDA guidelines: • Critical…
75	Protein Aggregation And SubVisible Particles	`protein aggregation and sub visible particles`	Protein Aggregation And SubVisible Particles Quality Checker — Aggregate and Particle Control ℹ️ Utility performs quality control of biopharmaceutical products, focusing on two critical safety aspects according to USP ,…
76	Bioassay Validity	`bioassay validity checker`	Bioassay Validity Checker — Проверка валидности биологического испытания (Ph.
77	Protein Concentration UV	`protein concentration uvquality checker`	Protein Concentration UV Quality Checker — Control of Protein Concentration and Purity (UV) ℹ️ Utility checks critical parameters of protein analysis by UV spectrophotometry: • Calculated concentration: within ±10% of ex…
78	Fluorescence Spectroscopy	`fluorescence spectroscopy`	Fluorescence Spectroscopy Quality Checker — Control of Fluorescence Analysis Quality ℹ️ Utility checks critical parameters of fluorescence spectroscopy: • Net Fluorescence Intensity: within specified range • Signal-to-Bl…
79	NMR Structure	`nmrstructure`	NMR Structure Quality Checker — Control of NMR Spectrum Quality ℹ️ Utility checks critical parameters of Nuclear Magnetic Resonance spectra quality (USP / Ph.
80	Cyclosporine	`cyclosporine`	Crizotinib Quality Checker — ALK/ROS1 Inhibitor (Ph. Eur., USP) ℹ️ The utility checks assay, particle size, impurities, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only.…
81	Tacrolimus	`tacrolimus`	Tacrolimus Quality Checker — Immunosuppressant (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, epimers, moisture, toluene. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL! Epimers ≤0…
82	Sirolimus	`sirolimus`	Sirolimus Quality Checker — Immunosuppressant (Ph. Eur., USP) ️ The utility checks assay, isomers, macrolide oxidation, hexane/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only.…
83	Methotrexate	`methotrexate`	Methotrexate Quality Checker — Methotrexate quality assessment (Ph.
84	Azathioprine	`azathioprine`	Azathioprine Quality Checker — Azathioprine quality assessment (BP/Ph.
85	Mycophenolate Mofetil	`mycophenolate mofetil`	Mycophenolate Mofetil Quality Checker — Immunosuppressant (Ph.
86	Prednisolone	`prednisolone`	Prednisolone Quality Checker — Glucocorticosteroid (Ph. Eur., USP) ️ The utility checks assay, isomer/oxidized/hydrolysis impurities, toluene/acetonitrile/dichloromethane, dissolution profile. ℹ️ Does not use machine lea…
87	Methylprednisolone	`methylprednisolone`	Methylprednisolone Quality Checker — Methylprednisolone quality assessment (Ph.
88	Dexamethasone	`dexamethasone`	Dexamethasone Quality Checker — Dexamethasone quality assessment (BP/Ph.
89	Hydrocortisone	`hydrocortisone`	Hydrocortisone Quality Checker — Hydrocortisone quality assessment (Ph.
90	Budesonide	`budesonide`	Budesonide Quality Checker — Glucocorticosteroid (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, impurities, aerodynamics (for inhalation), microbiology. ℹ️ Does not use machine learning — rule-based logi…
91	Albumin Human	`albumin human`	Albumin Human Quality Checker — Blood Product (Ph. Eur., USP) ℹ️ The utility checks monomers, PKA, aluminum, sterility, endotoxins. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL! Monomers ≥95%. PK…
92	Immune Repertoire MRD QC	`immune repertoire mrd qc checker`	Immune Repertoire MRD QC Checker — Immune Repertoire MRD Data Quality Control ℹ️ Utility performs comprehensive quality verification of TCR/BCR-seq data for MRD monitoring according to EuroClonality-NGS, AIRR Community a…
93	Sample Identity Consistency	`sample identity consistency checker`	Sample Identity Consistency Checker — Multi-Level Sample Identity Verification Performs comprehensive identity verification per CAP/CLIA §GEN.
94	Batch Release Json Builder	`batch release json builder`	Batch Release Json Builder — Certificate of Analysis (CoA) Generator ℹ️ Utility performs automated assembly and validation of data for the Certificate of Analysis according to GMP Annex 16 and 21 CFR Part 211.
95	Ravulizumab	`ravulizumab`	Ravulizumab Quality Checker — Comprehensive Quality Control for Ravulizumab Monoclonal Antibody Performs batch release assessment per ICH Q6B, USP , EP 2.

Package positioning

The package is a marketing and technical selection. It is suitable for the first discussion with QC, portfolio coverage assessment, pilot scoping and integration planning.

Immunology mAb Biologics Biosimilars ELISA SPR HCP Immunosuppressants CSV→JSON PackageArticle TherapeuticMapping Ravulizumab ComplementC5

Licensing & support

License is granted to one pharmaceutical company or manufacturing site, with no redistribution rights.
Utilities are provided as is; validation is performed by the client using URS & FS / IQ/OQ templates.
Integration support is available for LIMS/ELN/MES, pilot preparation and CSV/JSON workflow clarification.
No public price is shown: the commercial proposal depends on package scope, number of sites, delivery model and support level.

Questions? Need a QC demo or pilot?

Representative — FUZKK Pharma Utilities

Open package in the portal