Sartorius combines GAMP 4 software with benchtop bioreactor system

New technology enables design space characterisation for enhanced, large-scale process analytics

Sartorius supports mainstream adoption of QbD principles by the biopharmaceutical industry


Sartorius Stedim Biotech (SSB), an international supplier for the biopharmaceutical industry, has developed a fully integrated technology platform to meet the requirements of today’s upstream bioprocessing.

It will allow customers to adopt a quality by design (QbD) approach by allowing them to combine the power of high-throughput mini bioreactors with data analysis and knowledge management tools. This is so that robust and well-characterised processes can be scaled up at the first attempt.

The ICH Q8(R2) Guidelines define QbD as a systematic approach to development that begins with predefined objectives. It emphasises product and process understanding and process control, based on sound science and quality risk management.

The approach is borne out of the US FDA’s attempt to encourage the pharmaceutical industry to innovate, as highlighted in their 2002 initiative “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach.” According to Sartorius, full QbD adoption by the biopharmaceutical industry has yet to occur, despite generating considerable interest.

SSB is supporting the mainstream adoption of QbD principles by the biopharmaceutical industry as part of its Connect Upstream campaign. The campaign brings together the ambr 250 high throughput or modular systems (for defining cell culture design spaces at the laboratory-scale) with the MFCS supervisory control and data acquisition system (SCADA), 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 MFCS SCADA system is a feature-rich, GAMP category 4 software package based on over 25 years of experience and 3,000 installations worldwide. The integrated MODDE design of experiments and SIMCA software for multivariate data analysis enables (MVDA) the fast and straightforward implementation of a QbD approach to drug development. The S88 tool enables easy and safe recipe transfer across scales.

The company’s new scale conversion tool will minimise the risk that large-scale processes performed in single-use bioreactors will fail to generate the required critical quality attributes.

Sartorius has a range of single-use bioreactors with a conventional stirred-tank design that is ideal for high-density cell culture applications. The range has true scalability from process development through pilot to production scales, minimising both the effort associated with scaling up cell culture processes and the risk of process transfer even to larger-scale bioreactors.

The company’s PAT toolbox of sensors, controls tools and MVDA software allows analysis of critical process parameter during upstream processing.

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