FFuzkk Atlas of China
#70Official Top 100

RAAS Blood Products

上海莱士血液制品股份有限公司

#70

Vaccines and blood productsHeparin and plasma products

Manufacturing profile

Vaccines and blood products
Heparin and plasma products

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. 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. 6Raw-material receipt and identification
  7. 7Dispensing, blending and granulation
  8. 8Tableting, encapsulation or solution preparation
  9. 9Packaging and labelling

Relevant FUZKK packages

Huvac — Human Vaccine QC UtilitiesPlasma-Derived Products 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 CheckerHeparin Sodium Quality CheckerResidual Solvent Detergent Checker

Lumex — instrumental QC

HeparinSodiumMolecularWeightCheckerCE DNA Vaccine Purity CheckerFluorat Aluminum VaccinesMercury Analyzer Vaccine ThimerosalFluorat Nucleic Acids QuantifierCE Recombinant Protein PurityLabWare CDS Bridge ConnectorCE Inorganic Ions Analyzer

LabEx — laboratory QC

Bacterial Endotoxins LAL Quality CheckerSterility Test Membrane Filtration Quality CheckerParticle Count Injection USP <788> 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