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 cell banks for our clients all around the world
Experts in Cell Banking Services
Huge expertise in microbial cell bank development, specially wotking with bacterias like E. coli, yeast like Pichia Pastoris and fungal platforms. From non-GMP RCB to full GMP MCB, we offer tailored solutions for cell bank generation and characterization.
Trust us to deliver quality and stability across both microbial cell banks.
Master Cell Bank Manufacturing
Working Cell Bank Manufacturing
End of Production Cell Bank Generation
Full Characterization Services
Long Term Storage in GMP controlled area
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:
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.
Different Microorganisms
Our Facilitities are adapted to work with a wide range of microorganisms, from aerobic to facultative and obligate anaerobes, including those that are genetically modified. In addition, our facilities are certified to handle organisms classified at BSL1 and BSL2 biosafety levels, ensuring a controlled environment for all stages of the cell banking process.
At 53Biologics we ensure that our facilities meet the highest standards of safety and regulatory compliance.