Sartorius Stedim Biotech says its newly launched mammalian cell bank manufacturing offering fits hand-in-hand with its existing cell line development services.

German bioprocess vendor Sartorius has grown its contract testing and manufacturing services over the past few years, not least through the acquisition of analytics and product characterization firm BioOutsource in 2015.

Now the subsidiary Sartorius Stedim BioOutsource will offer the manufacture of GMP master and working cell banks (MCB/WCB) for mammalian suspension cells from its site in Glasgow, UK. The firm adapted and equipped 260 m² of lab space at the site to and now boasts a GMP facility for cell bank manufacturing facility.

Image c/o SSB

“The facility was audited and approved in 2018 by the MHRA [the UK’s Medicines and Healthcare products Regulatory Agency] according to the latest guidelines and is holding an MIA (IMP) license,” Lucia Rieger, product manager for Protein Expression Systems at SSB told Bioprocess Insider.

“The selected Sartorius equipment for the facility enables us to offer manufacturing in a closed system for highest possible hygiene and quality standard. Several experts were hired with a long-lasting history and experience in the environment of GMP cell banking services to achieve expert driven manufacturing.”

The firm will be able to produce up to 500 cell bank vials during a manufacturing run, followed by full characterization, genetic stability assessment.

Complementary services

The addition of cell banking service is, according to Rieger, the “perfect extension” to Sartorius’ cell line development services, completing a portfolio built on its acquisition of German contract services company Cellca in 2015.

“The cell line development services are performed based on the Cellca CHO expression and Medium platform and is offered with a timeline from DNA to RCB of four months. Combined with the new cell bank manufacturing offering the client can profit from a timeline from DNA to fully characterized MCB in 10 months.”

Rieger added the DNA to MCB offering offers flexibility and independence to allow customer projects to start on short notice, incorporating any fast scope changes or even unexpected project cancellation without any consequences for the client.

“This flexibility, which is of main importance during the development of biologics to overcome unforeseen challenges easily, is combined with an outstanding customer service handled through a single point of contact for the whole service from DNA to released MCB.”