Sartorius Stedim will now offer mammalian cell bank manufacture under good manufacturing practice (GMP) conditions through its subsidiary, Sartorius Stedim BioOutsource, a contract testing organization (CTO) based in Glasgow, UK, and Cambridge, Massachusetts.
The organization can now support the manufacture of GMP master and working cell banks for mammalian suspension cells at its 260 square-meter cleanroom facility. The GMP production site is exclusively dedicated to mammalian suspension cell lines using selected equipment to establish a closed-system manufacture of cell banks.
Cell bank characterization will also be offered as part of a package from the company. According to Sartorius Stedim, the combination of the two services enables clients to work with the company as a single-source provider from vial thaw to released cell banks, ensuring faster timelines.
Lucia Rieger, product manager for the protein expression system at Sartorius Stedim, told us biopharma companies have a challenge to get identified biologics to the market as fast as possible. “The starting point for the development of a biological drug is always the need for a cell line expressing the biological drug,” she added.
The company stated that up to 500 cell bank vials are created during a manufacturing run and then shipped to the client or a long-term storage facility to streamline the supply chain.
Sartorius Stedim already provides cell line development through its CHO expression platform. According to the company, by combining all three services – cell line development, cell bank manufacturing, and cell bank characterization – Sartorius Stedim can support clients as a total solutions provider from DNA to GMP cell bank in 10 months.
“After the launch of the GMP cell banking services Sartorius closed that gap and is now a single-source provider from cell line development, followed by GMP cell banking to cell bank characterization,” Rieger added.