Our services

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Cell banking services

Our GMP-compliant cell banking services support production and QC assay cell lines across human, mammalian, insect, yeast, and bacterial systems, with segregated BSL-2 suites and comprehensive solutions including MCBs, WCBs, and research cell banks with GMP-aligned QC testing

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GMP manufacturing

We provide GMP manufacturing of Master and Working Cell Banks for mammalian, insect, and microbial cell lines used in protein expression or plasmid DNA production for human and veterinary applications. We also support non-production cell lines for QC assays. Prior to GMP transfer, cell growth and quality are verified at small scale.

Our facility offers secure cell storage at -80°C or in vapor-phase liquid nitrogen, with 24/7 monitored ULT freezers and cryogenic tanks.

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Quality and stability testing

Quality testing of a cell bank is a critical aspect of ensuring the safety, consistency, and reproducibility of biopharmaceutical products and to avoid variability when cell lines are used for QC purposes. Widely known for its analytical testing, all assays to characterize cell lines are available within Eurofins CDMO.

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Our expertise 

 

  • Manufacturing in accordance with EMA and FDA requirements
  • Segregated, grade A/C suites, ISO 5/7 cleanrooms
  • Cultivation of BSL1/BSL2 organisms
  • Qualified equipment
  • Cell culture using serum-free and animal component free media
  • Filling within certified laminar flow biosafety cabinets (Class A)
  • QP certification


Deliverables:

  • Executed and detailed batch record documents
    Manufacturing report
    Certificate of GMP compliance
    BSE/TSE statement
    Certificate of analysis (CoA)
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