FFuzkk Atlas of China
#41Official Top 100

Innovent Biologics

信达生物制药（苏州）有限公司

#41

BiologicsOncology, ADC and high-potency

Manufacturing profile

Biologics
Oncology, ADC and high-potency

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. 1Cell bank or microbial seed
  2. 2Upstream culture or fermentation
  3. 3Clarification and chromatography
  4. 4UF/DF, formulation and sterile filtration
  5. 5SEC, CE, LC-MS, ELISA, qPCR and bioassay QC
  6. 6Raw-material receipt and identification
  7. 7Dispensing, blending and granulation
  8. 8Tableting, encapsulation or solution preparation
  9. 9Packaging and labelling

Relevant FUZKK packages

Global API & Biosimilars QC SuiteADC / Conjugated Biologics QC SuiteLabEx QC Suite

Product/API utilities

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

Lumex — instrumental QC

CE Glycosylation ProfilerCE mAb Aggregates FragmentsCE mAb Charge Variant CheckerCE Recombinant Protein PurityCE Peptide Map ValidatorFluorat Nucleic Acids QuantifierLabWare CDS Bridge ConnectorGenotoxic Impurity Screener M7AAS Catalyst Residues Pd Pt Rh

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

Supplier Evaluation CheckerCalibration Status CheckerProcess Validation CheckerChange Control Impact CheckerData Integrity Security CheckerRequirement Traceability 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