Milestone for the medicine of tomorrow

The state-of-the-art biotechnology facility of the pharmaceutical manufacturer Teva in Ulm is specifically designed for the production of new innovative antibody medicines. © Teva Germany

© Teva Germany

© Teva Germany

Press tour © Teva Germany

Stefan Fügenschuh, Vice President & Site General Manager Teva Biotech Ulm © Teva Germany

Bernd Häggele, Vice President BMSO Engineering Business Partner © Teva Germany

It is a project of superlatives: The parent company of Ratiopharm, Teva, is investing around one billion US dollars at the Ulm site in biotechnological production. Starting in 2025, biopharmaceuticals will be produced in enormous bioreactors in the Ulm Danube Valley. These medicines are used for complex, sometimes life-threatening diseases, such as treatment of cancer or tumor diseases or for pain patients. The consulting firm Drees & Sommer SE, specializing in construction and real estate, is supporting Teva during the demanding construction and commissioning phase.

From the outside, the building with the project name "Genesis" already looks quite finished. Inside, however, the final preparatory work is in full swing to approve the facilities and train the employees. It quickly becomes clear why planning and construction are so challenging: "The production of biopharmaceuticals is very complex and technologically demanding," explains Stefan Fügenschuh, who is responsible for the biotechnology division at Teva Germany. It has nothing to do with simple tablet presses, because the production of biopharmaceutical medicines fundamentally differs from the manufacturing of pharmaceutical drugs. Biopharmaceuticals are biotechnologically produced medicines, for which living cells or organisms are used in the production process.

"In the new facility, everything is perfectly coordinated, the entire building is almost fully digitalized and automated," says Bernd Hägele, Vice President Global Engineering Business Partner Teva. Genesis thus serves as a pioneer and blueprint for the next level of automation at Teva. Over 26,000 measuring devices monitor the operation with utmost precision, a total of 16 kilometers of stainless steel pipes and around 300 kilometers of cables run through the eight floors. For an efficient construction process, Teva has therefore brought in the life sciences experts from Drees & Sommer.

Entry during ongoing project

Since the end of 2019, the team from Drees & Sommer has been supporting the construction of the new building and has been managing a series of challenges ever since. In an initial step, the construction experts conducted a detailed 360-degree analysis of the project. All plans, processes, and the entire organization were scrutinized. Based on this analysis, the team developed optimization proposals. "For a smooth construction process, a clear requirements profile is fundamentally important. Together with the client, we first defined clear decision-making pathways and set realistic goals for the completion of the new building within a certain time and cost frame," explains Jannik Grünenbaum, project team leader at Drees & Sommer.
This also included a professional and transparent organization of workflows for over 1,000 subsystems – such as facade, fire elevator, or lightning protection. "Furthermore, we established the information flow between the individual trades so that they can be coordinated. During peak phases, we had 16 different companies on the construction site, over 100 equipment suppliers, and over 1,400 workers to coordinate – that’s impossible without transparent planning," Grünenbaum continues. Especially during the COVID-19 pandemic, this coordination was particularly important.

COVID crisis required bottleneck management

In addition to project-specific framework conditions, aspects such as hygiene and safety were the focus during the pandemic. Thermal imaging cameras for temperature measurement and ventilation systems were installed to keep the risk of infection as low as possible. Work was switched to a two-shift operation, and Saturday was introduced as an additional workday. "Predefined risk scenarios including corresponding action instructions are particularly important in such cases to ensure reliable planning," reports Stefan Göstl, who, as an Associate Partner and Head of Chemicals & Life Sciences at Drees & Sommer, accompanies numerous Fast Track projects. To minimize the risk of failure, redundancies in the execution teams per shift could, for example, be established.

Teva has not yet commissioned the new production facilities. Currently, the qualification and commissioning phase is underway. Followed by test runs and approval of the plant by the relevant authorities. When Genesis is expected to begin commercial production at the end of 2024 / beginning of 2025, around 300 employees will be working there on the production of the new active ingredients.

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Facts:
BIOTECH PROJECT GENESIS:
MILESTONE FOR THE MEDICINE OF TOMORROW

KEY DATA
> Start of construction: 2017
> Completion: End of 2024 / Beginning of 2025
> Investment: around 1 billion US dollars in biotechnological production at the Ulm site
> 45,000 m²
> 300 new jobs at full capacity
> Building type: Production, cleanroom, office

BUILDING HIGHLIGHTS
> State-of-the-art highly automated plant design
> Two independent production lines, parallel manufacturing of different products
> 4 x 5,000-liter bioreactors (Line 1)
> 2 x 15,000-liter bioreactors (Line 2)
> Up to 7 weeks upstream process from thawing the cell bank to harvest
> About 1 week downstream process until filling
> 26,000 measuring devices monitor production & building
> 16 kilometers of stainless steel piping
> 300 kilometers of cables
> 1,400 workers, 100 equipment suppliers, and 16 different companies active at peak times on the construction site
> Comprehensive hygiene concept during construction to prevent COVID-19: thermal cameras, ventilation systems, two-shift operation
> 360-degree analysis and ongoing reporting on project status
> Tight local construction situation posed high logistical demands

DREES & SOMMER SERVICES
> 360-degree analysis, overall construction management TEVA,
> Construction management, construction supervision on the client side against the EPCM contractor, anti-claim management, variation negotiations for construction time extension with EPCM contractor and construction companies, fire protection expertise, cleanroom expertise,
facade expertise, project communication management, data management