The platform will allow customers to adopt a Quality by Design (QbD) approach in which they build quality into their biological products by combining the power of 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 ICH Q8(R2) Guidelines define Quality by Design as a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
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.
