Enables Robust, Flexible Bioprocess Development in Single-use Bioreactors

Sartorius Stedim Biotech (SSB) today announced the 2015 version of the ambr^® systems (ambr^® 15 and ambr^® 250) will be supplied with integrated BioPAT^® MODDE Software for Design of Experiments (DoE), powered by Umetrics. This will allow bioprocess scientists to easily implement DoE into their work flow for simpler process optimisation and scale-up to larger single-use BIOSTAT^® pilot and manufacturing scale bioreactors, making bioprocess development faster and more cost-effective.

The integrated DoE software will enable scientists to quickly establish a Design Space where relevant bioprocessing conditions are varied simultaneously. Users can rapidly configure DoE experiments via work packets that are exported from the software to the ambr system; configuring each micro bioreactor with its own DoE defined bioprocessing parameters. The data generated from ambr, including offline analytics, is analysed within the software to identify critical process parameters, optimise bioprocessing conditions and define a robust design space for implementation in larger single-use BIOSTAT pilot and manufacturing scale bioreactors.

This extended DoE functionality is also available to existing ambr users who can assess the utility of the BioPAT MODDE software via a free 60 day trial, with the option of purchasing the full version if they want to continue to run DoE programmes.

Dr Barney Zoro, ambr15 Product Manager at SSB commented: "To facilitate greater implementation of DoE across the industry we have combined the power of ambr with the BioPAT MODDE software. These synergistic technologies are ideally suited for media optimisation and process parameter screening applications. Additionally, the software can be used for Monte Carlo Simulations as part of a Quality by Design (QbD) programme to identify the desired operating region for manufacturing scale processes, to make scale-up quicker and simpler.”

Mario Becker, Director of Marketing, PAT and Automation at SSB, continued: “Our major goal is to ensure that bioprocess scientists can develop their processes as quickly as possible. Providing a consistent, scalable platform for DoE studies and data analysis which is seamlessly integrated with the full range of ambr and BIOSTAT systems, will help scientists develop robust and flexible manufacturing processes based on single-use bioreactor technology. Ultimately, implementing this approach and extending it with the BioPAT SIMCA MVDA toolkit will contribute to biotech and pharma firms reducing risk in bioprocess development and achieving more rapid, cost-effective production of their biologics and vaccines.”

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