With a Simatic PCS7-based automation solution, Phyton Biotech benefits from significantly increased production flexibility in a new fermenter cascade.

Phyton Biotech of East Windsor, New Jersey, is the world market leader in the field of industrial plant cell culture technology for the production of high-quality pharmaceutical ingredients. The company belongs to the DFB Pharmaceutical Group, which is headquartered in Fort Worth, Texas. R&D are located in East Windsor, New Jersey. At its production site in Ahrensburg in the north of Germany, Phyton operates the world's largest plant cell fermentation facility, with fermenters with a capacity of up to 75,000 liters. Here, Taxol® for Bristol-Myers Squibb is obtained from cells of the yew tree. This drug is used in cancer therapy. In 2005 the company decided to build another new fermenter cascade, which required engineering, hardware and software, and the qualification and validation of the plant in accordance with GAMP 4.

Ingredients are obtained by fermentation of plant cells in the fermenter cascade (Photo: Phyton Biotech GmbH)

Experience yields immediate benefits

Phyton decided to continue its longtime partnership with the Hamburg branch of Siemens and to change over to the Simatic PCS7 process control system in combination with Simatic Batch. It was not only Siemens' experience with the existing production plant that was decisive but also the fact that Siemens was able to offer all the technology and associated services as a full-service provider. Thanks to the extensive expertise of the Siemens project team, Phyton could also be certain that the automation solution would be exactly adapted to the requirements of the fermenter cascade. In addition, Siemens was able to rely on a considerable amount of experience with similar plant extensions.

The project had to be completed within a relatively tight time schedule. The order was placed in 2005, and the factory acceptance test (FAT) was performed in June 2006. The commissioning took place in October 2006. This was followed by qualification and validation, until the project's final completion in June 2007. This time frame was only possible because Siemens used its PM@Siemens management system and time-saving tool-aided software engineering.

Flexible batch control

A total of five PCS7 automation systems have been implemented in the fermenter cascade. The system also includes a redundant server pair, an engineering station, three clients for the operation of the processes, and a central archive server for the long-term archiving of process data.

A special challenge for the Siemens engineers was the programming of the Simatic Batch solution. It was important not only to process the extensive recipes that are typical for this type of production but also to implement a highly flexible recipe structure that could be transferred to other products with little effort later – a requirement that could be met consistently and intelligently with Simatic Batch. Of course, the whole solution was also qualified according to GAMP 4.

Stronger relations

The quick, successful implementation of the new solution further strengthened the existing partnership between the two companies. The team at Phyton Biotech implemented a process control system that is compliant with GAMP- and FDA requirements based on standard products and is very flexible and open for expansion. This means that Phyton is optimally equipped to face future challenges.

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