FFuzkk Atlas of China
#53Official Top 100

Baili Pharma

四川百利药业有限责任公司

#53

Oncology, ADC and high-potencyBiologics

Manufacturing profile

Oncology, ADC and high-potency
Biologics

Region: Sichuan

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

ADC / Conjugated Biologics QC SuiteGlobal API & Biosimilars QC SuiteLabEx QC Suite

Product/API utilities

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

Lumex — instrumental QC

CE Glycosylation ProfilerCE mAb Aggregates FragmentsCE mAb Charge Variant CheckerCE Peptide Map ValidatorGenotoxic Impurity Screener M7AAS Catalyst Residues Pd Pt RhLabWare CDS Bridge ConnectorCE Recombinant Protein PurityFluorat Nucleic Acids Quantifier

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerLC-MS Confirmation Quality CheckerSterility Test Membrane Filtration Quality CheckerBiologic 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 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