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Upstream Bioprocessing
From Pre-clinical to Manufacturing


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Prevent Contaminants



Prevent Contaminants

Regulatory agencies and international organizations provide a framework to assure the safety of biologics through prevention of contamination from microorganisms. New scientific advances and technical innovations continue to enhance biosafety initiatives.



Cell Line Development

Ensure continued stability and safety of cell lines

Establishing master and working cell banks is critical to supporting clinical development through commercial supply. Safeguarding precious cells under cGMP conditions is paramount.

Cell line characterization is required by regulatory agencies to confirm the species origin and history of the cell line and test identity, stability, and purity. Characterization includes phenotypic or genotypic identity testing and a broad range of adventitious agents testing.




No Viruses Allowed

Video: Tech Talks - Voice of the Experts: Virus contamination prevention in upstream processes

A major component of a viral safety strategy is preventing viruses from entering upstream cell culture processes. This is supposed by careful selection of cell lines and raw materials and implementation of new virus inactivation or barrier technologies designed to prevent viral contaminants from entering upstream processes.