FFuzkk Atlas of China
#47Official Top 100

Roche (Shanghai)

上海罗氏制药有限公司

#47

Multinational pharmaceutical operations in ChinaBiologicsIVD and diagnosticsOncology, ADC and high-potency

Manufacturing profile

Multinational pharmaceutical operations in China
Biologics
IVD and diagnostics
Oncology, ADC and high-potency

Region: Shanghai

Selection basis

The company is included in the official 2024 ranking of the 100 largest Chinese pharmaceutical-industry enterprises by main-business revenue.

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Representative manufacturing and QC chain

  1. 1Raw-material receipt and identification
  2. 2Dispensing, blending and granulation
  3. 3Tableting, encapsulation or solution preparation
  4. 4Packaging and labelling
  5. 5HPLC, GC, KF, ICP/AAS, dissolution and stability QC
  6. 6Cell bank or microbial seed
  7. 7Upstream culture or fermentation
  8. 8Clarification and chromatography
  9. 9UF/DF, formulation and sterile filtration

Relevant FUZKK packages

Global API & Biosimilars QC SuiteMedical Device QMS SuiteMedical Device Software SuiteMedical Devices Standards & Lifecycle QC SuiteADC / Conjugated Biologics QC SuiteLabEx QC SuiteMedical Device Risk Management Suite

Product/API utilities

Residual Host Cell DNA Quality CheckerResidual Host Protein CheckerCompanion Diagnostic Report CheckerADC Aggregation MonitorADC Drug Antibody Ratio AnalyzerADC Free Payload QuantifierADC Linker Stability ProfilerADCRelease Readiness Checker

Lumex — instrumental QC

Method Validation Data PackagerCE Glycosylation ProfilerLabWare CDS Bridge ConnectorGenotoxic Impurity Screener M7Content Uniformity Acceptance ValueCE mAb Aggregates FragmentsCE mAb Charge Variant CheckerCE Recombinant Protein PurityCE Peptide Map ValidatorFluorat Nucleic Acids Quantifier

LabEx — laboratory QC

Biologic Aggregate Size Quality CheckerCharge Variant CE Quality CheckerProtein Concentration UV Quality CheckerELISA Bioassay Quality CheckerSPR Binding Affinity Quality CheckerEndotoxin Biologic Product Quality CheckerAutomated Sterility Detection Quality CheckerAssay & Impurity HPLC Quality CheckerLC-MS Confirmation Quality CheckerSterility Test Membrane Filtration Quality Checker

Medical Devices — equipment and software lifecycle

Change Control Impact CheckerProcess Validation CheckerData Integrity Security CheckerRequirement Traceability CheckerSupplier Evaluation CheckerProduction Record Consistency CheckerRelease Readiness CheckerSoftware Safety Class CheckerIntegration Test Coverage CheckerCybersecurity Risk Assessment CheckerElectrical Safety Test Summary CheckerEMCTest Coverage Checker

Suggested first pilot

  1. Confirm one real product, method or recurring QC review.
  2. Record the instrument, export format and current specification.
  3. Select 3–7 utilities from the map above.
  4. Run a PASS/FAIL sample and agree the expected output.
  5. After user validation, expand the scope.

Mapping boundary

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Methodology