FFuzkk Atlas of China
#24Official Top 100

Changchun High-Tech

长春高新技术产业（集团）股份有限公司

#24

BiologicsVaccines and blood productsTCM and herbal products

Manufacturing profile

Biologics
Vaccines and blood products
TCM and herbal products

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. 6Biological inputs or plasma pooling
  7. 7Purification and viral-clearance stages
  8. 8Formulation and adjuvant/protein control
  9. 9Sterile filling or lyophilisation

Relevant FUZKK packages

Global API & Biosimilars QC SuiteHuvac — Human Vaccine QC UtilitiesPlasma-Derived Products QC SuiteHerbal / TCM / Ayurveda Instrumental QC SuiteBritish Herbal Pharmacopoeia QC SuiteLabEx QC SuiteChina: national essential medicines QC package

Product/API utilities

Residual Host Cell DNA Quality CheckerResidual Host Protein CheckerVaccine 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 CheckerChromatographic Fingerprint Similarity CheckerHerbal Chromatographic Fingerprint Analyzer

Lumex — instrumental QC

CE Glycosylation ProfilerCE mAb Aggregates FragmentsCE mAb Charge Variant CheckerCE Recombinant Protein PurityCE Peptide Map ValidatorFluorat Nucleic Acids QuantifierLabWare CDS Bridge ConnectorCE DNA Vaccine Purity CheckerFluorat Aluminum VaccinesMercury Analyzer Vaccine Thimerosal

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 CheckerBacterial Endotoxins LAL Quality CheckerSterility Test Membrane Filtration Quality CheckerWater Content KF 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