53Biologics

Proteins Cell Banking

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We are fully capable to produce and characterize Master Cell Banks (MCB) and Working Cell Banks (WCB).
In our GMP compliant suits we operate under an appropriate quality system for MCB and WCB manufacturing, characterization and release according to the ICH guidelines. Our team works with you through all stages of cell bank manufacturing, from the initial inquiry, design, and initiation of your project to the production, characterization, storage, and stability testing.

We have generated and characterized microbial and mammalian cell banks for our clients all around the world

Experts in Cell Banking Services

  • Master Cell Bank (MCB) Manufacturing
  • Working Cell Bank (WCB) Manufacturing
  • End of Production Cell Bank (EoPCB) Generation
  • Full Characterization Services
  • Long Term Storage in our GMP controlled area

Our team has a deep expertise in microbial cell bank development, but we are also experienced in mammalian cell bank development in a wide variety of stains and cell lines:

  • Bacteria: Escherichia coli
  • Yeast: Pichia pastoris
  • Fungal: Trichoderma, Aspergillus and the revolutionary Myceliophthora thermophila (C1)
  • Mammalian: CHO and HEK293
  • Insect: Sf2

Analytical Services for Cell Banking

We offer a strong catalogue analytical services including identity, purity, viability and stability following molecular, genetic and microbial assays like:

  • Identity testing, i.e. 16S rRNA Sequencing, Plasmid or Expression Construct Sequencing, Restriction Fragment Analysis by Southern Blot.
  • Purity determination, i.e. API 20 Test, Gram Staining, Bacterial & Fungal Impurities, etc.
  • Viability, i.e. colony forming units counts
  • Stability determination, i.e. Marker Retention Testing, Copy Number Analysis by qPCR.

Our team works with you through all stages of cell bank manufacturing, from the initial inquiry to the characterization, storage and stability testing.

Discover more about 53Biologics protein services

Strain & Cell Line Development

We have wide experience in E. coli, P. pastoris and fungal strain development and mammalian cell line development for the manufacturing of your biologic.

Process Development

Our experts in Upstream and Downstream Development provide personalized attention and ensure the most effective and innovative solutions for complex challenges.

Protein Manufacturing

We offer a wide range of manufacturing capacities for your enzymes, monoclonal antibodies, biosimilars or vaccines under GMP and non-GMP conditions.

Analytical Services

From early development to commercial manufacturing, we provide multiple analytical testing services to support your protein project.

Take advantage of our cell banking services.