Sartorius Supports Mainstream Adoption of QbD

Sartorius Stedim Biotech (SSB) has developed a technology platform that will allow customers to adopt a Quality by Design (QbD) approach in which they build quality into their biological products by combining the high-throughput mini bioreactors with data analysis and knowledge management tools so that robust and well-characterized processes can be scaled up at the first attempt.

The company says despite considerable interest, full QbD adoption by the biopharmaceutical industry has yet to occur.

SSB is supporting the mainstream adoption of QbD principles by the biopharmaceutical industry as part of its "Connect Upstream" campaign that brings together the ambr 250 high throughput or ambr 250 modular systems for defining cell culture design spaces at the laboratory-scale with the MFCS SCADA system for data analysis and knowledge management. The new ambr 250 modular is a high-performance benchtop bioreactor system for parallel fermentation or cell cultivation. Central to the system is a new 100–250 mL single-use vessel design, fully integrated with liquid reservoirs and syringe pumps.

The company says its new scale conversion tool will help to minimize any risk that large-scale processes performed in Biostat STR single-use bioreactors do not generate the required critical quality attributes. The Biostat STR family is a range of completely single-use bioreactors with a conventional stirred-tank design that is ideal for high-density cell culture applications.