FFuzkk Atlas of China
#72Official Top 100

Hualan Bio

华兰生物工程股份有限公司

#72

Vaccines and blood productsBiologics

Manufacturing profile

Vaccines and blood products
Biologics

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. 1Biological inputs or plasma pooling
  2. 2Purification and viral-clearance stages
  3. 3Formulation and adjuvant/protein control
  4. 4Sterile filling or lyophilisation
  5. 5Potency, sterility, endotoxin and cold chain
  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

Huvac — Human Vaccine QC UtilitiesPlasma-Derived Products QC SuiteGlobal API & Biosimilars QC SuiteLabEx QC Suite

Product/API utilities

Vaccine Potency AssessorAdjuvant Aluminum Assay CheckerAdjuvant Adsorption Efficiency Quality CheckerInactivated Vaccine Safety Test Quality CheckerLive Attenuated Vaccine Genetic Stability Quality CheckerPlasma Pool Traceability CheckerPlasma Viral Clearance Evidence CheckerCold Chain Shipping Temperature And MKT Quality CheckerResidual Host Cell DNA Quality CheckerResidual Host Protein Checker

Lumex — instrumental QC

CE Glycosylation ProfilerCE DNA Vaccine Purity CheckerFluorat Aluminum VaccinesMercury Analyzer Vaccine ThimerosalFluorat Nucleic Acids QuantifierCE Recombinant Protein PurityLabWare CDS Bridge ConnectorCE mAb Aggregates FragmentsCE mAb Charge Variant CheckerCE Peptide Map Validator

LabEx — laboratory QC

Bacterial Endotoxins LAL 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