F Fuzkk Atlas of the USA
#182Extended selection 101–500

SOFIE Biosciences

California

BiologicsRadiopharmaceuticals

Manufacturing profile

Biologics
Radiopharmaceuticals

Biopharma hub: California

Selection basis

The company is placed in positions 101–500 as a manufacturer, biotech, generics, advanced-therapy company or CDMO with practical relevance to the FUZKK utility catalog.

The Top 500 is a FUZKK atlas priority rather than a single official revenue table. Inclusion in an FDA or industry source does not mean product approval, confirmation of a site's current status or actual use of FUZKK.

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. 6Radionuclide production or generator handling
  7. 7Shielded synthesis and hot-cell operations
  8. 8Sterile filtration and aseptic dispensing
  9. 9Activity, identity and radionuclidic/radiochemical purity

Relevant FUZKK packages

United States: national essential medicines QC packageGlobal API & Biosimilars QC SuiteLabEx QC SuiteRPH: combined radiopharmaceutical QC packageRadioligand & Theranostics Expansion QC Suite

Product/API utilities

Residual Host Cell DNA Quality CheckerResidual Host Protein CheckerRadionuclidic Purity CheckerCold Chain Shipping Temperature And MKT Quality Checker

Lumex — instrumental QC

CE Glycosylation Profiler

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 CheckerParticle Count Injection USP <788> Quality Checker

Medical Devices — equipment and software lifecycle

Supplier Evaluation CheckerCalibration Status CheckerProcess Validation CheckerChange Control Impact CheckerRequirement Traceability CheckerData Integrity Security 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 to other products and sites.

Mapping boundary

The Top 500 is a FUZKK atlas priority rather than a single official revenue table. Inclusion in an FDA or industry source does not mean product approval, confirmation of a site's current status or actual use of FUZKK.

Methodology