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Pharmaceutical Processing News
News Release from: Emerson Process Management | Subject: New PAT tools
Edited by the Processingtalk Editorial
Team on 07 April 2008
New PAT tools to speed drug development
unveiled
The Emerson high fidelity cell growth models and multivariate process analytics accelerate product development, speed scale-up to full production, and enable real-time release of biological products
The most recent Emerson work is in the development models for mammalian cell processes that are currently in Beta testing Cell growth models for bacterial, fungal, and yeast fermentations are available now
This article was originally published on Processingtalk on 30 Dec 2002 at 8.00am (UK)
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Previous studies indicate that the models can be used to prototype model predictive control of growth and product formulation rates which can in some cases reduce batch times by 40% and improve yields by 10%.
Biopharmaceutical product development is difficult and risky.
Currently more than 200 biotechnology medicines are in development for more than 100 diseases.
Due to process complexity, the products generally result only after lengthy iteration between process development and commercialisation.
Traditional development requires hundreds of trial batches, and then extensive data collection for final selection of processing conditions.
The new Emerson PAT tools shorten the time and cost of development, and use real-time data to improve quality and yield of released final product.
The new tools use off-line dynamic computer simulations of bioprocesses that can be run at up to 1000X real time to determine optimum settings for real-time production.
Also, for on-line operation, embedded analytics tools may be used to detect faults and predict end of batch values of quality parameters continuously in real time, helping to optimise batch process control and enable the efficiency of real-time release.
These new PAT tools for bioreactor modelling are in a library of software modules that run in t he Emerson DeltaV digital automation system.
The model, configuration, and tools are used to create a "virtual plant" that can simulate batch execution faster than by physical experimentation.
PAT tools are also being developed as embedded software in the DeltaV system to support on-line analytics.
The DeltaV system is commonly used in product development and is the process management system embedded in the Broadley-James bioreactor family.
The bioreactor models are available as a complete DeltaV solution designed specifically for the customer product development application.
Engineering and configuration services and training are included, supporting user needs for efficient operation and maintenance of the production simulation software.
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