Medicines from cells

BDC Exterior view, © Boehringer Ingelheim

Research and Development, Biberach, © Boehringer Ingelheim

Presentation with Dr. Fridtjof Traulsen, © Böhlinger Ingelheim

Press conference with Dr. Veit Bergendahl, © Böh­ringer Ingelheim

Discussion with Dr. Fridtjof Traulsen and Dr. Ralf Schumacher, © Böh­ringer Ingelheim

A laboratory as large as five football fields and investments amounting to 350 million euros: The pharmaceutical giant Boehringer Ingelheim, Germany's second-largest pharmaceutical manufacturer, has opened a new biotechnology development center in Biberach, Baden-Württemberg. There, medicines derived from cell cultures are developed, which are used for treating cancer or immune diseases. The consulting firm Drees & Sommer SE, specializing in construction and real estate, accompanied the company from detailed planning to commissioning.

Biopharmaceuticals are currently among the fastest-growing segments in the pharmaceutical industry. They open up therapeutic possibilities for serious illnesses such as cancer or multiple sclerosis. The Biberach site is Boehringer Ingelheim's largest research and development center worldwide. In the new building complex, the Biologicals Development Center, around 500 employees will produce active ingredients from laboratory scale to clinical trials.

To create optimal working conditions, the company relies on a cleanroom concept that integrates office, laboratory, and production areas. "The building provides the Development Biologicals department with state-of-the-art infrastructure and flexible equipment. Through this building concept, we bring together employees who develop processes, produce active ingredients, and understand molecules in a very open exchange. They will work closely together here and conduct development at the highest level," explains Ralf Schumacher, Head of Biotechnological Development at Boehringer Ingelheim.

High demands on project management

The pharmaceutical company set high standards for the new build: "The quality expectations in life sciences projects are enormous, and the time pressure in super-fast-track projects is extreme," explains Stefan Göstl, Associate Partner and Head of Life Sciences & Chemicals at Drees & Sommer. "Pharmaceutical quality assurance systems must already be considered during planning and construction; otherwise, deadlines and budgets cannot be maintained. Therefore, we rely on what is called integrated project management, which defines planning, construction, and process technology as a unified entity and coordinates them optimally."

At Boehringer Ingelheim, Drees & Sommer started with a 360-degree analysis of the ongoing project to gain an accurate overview of the current status and derive the next steps. Subsequently, the team took on various tasks in the Project Management Office (PMO), supported the implementation of lean systems, contractor management, commissioning support, and contributed to relocation management and the control of outstanding issues.

Commissioning guided – quality from the start

Even before the last trades were completed, the commissioning of the new development center was underway. According to Stefan Göstl’s experience, this final phase before handover is not only significant in terms of time but also financially: "The enormous complexity of the industry, high safety standards, and regulations that must be adhered to during commissioning mean that commissioning new facilities accounts for eight to fifteen percent of the total investment. Lack of knowledge or wrong decisions can quickly become very costly. Every commissioning is different and requires specific expertise and tailored solutions." The main reason for this lies in the diversity and variety of qualities, resources, and not least, the new project participants, who are sometimes involved for the first time at this stage of a project. As a result, different, sometimes conflicting interests, as well as varying levels of knowledge and competencies among project participants, users, and stakeholders, come into play and must be considered.

Central Project Management Office provides structure

"To capture the actual project status transparently, we implemented a consistent reporting system and various tracking tools," says Ulrich Kaufmann, Associate Partner at Drees & Sommer SE. A clear interface management is particularly important. For good reason: Usually, the numerous involved companies and their individually agreed contractual scopes do not align 1:1. It is especially important here to identify and close gaps early.

A specialized progress tracking & reporting tool compares the originally planned and actual project progress. It acts as an early warning system, allowing challenges to be identified early and actively mitigated. According to Ulrich Kaufmann, besides the right tools, experience also plays a crucial role: "Even the smallest wrong decision can negatively impact the overall project, leading to costly delays or rework."

The PMO was also an essential part of the leadership team for commissioning. It implemented a tailored project structure, created reports, coordinated costs and schedules, and ensured complete documentation for Boehringer Ingelheim.

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Facts:
BIOLOGICALS DEVELOPMENT CENTER:
STATE-OF-THE-ART RESEARCH INFRASTRUCTURE

KEY DATA
> Construction start: 2018
> Completion: Spring 2023
> Investment: around 350 million euros
> 500 new jobs at full capacity
> 34,500 m² across eight floors with around 450 individual systems
> Building type: Research & Development, Cleanroom, Production, Office

SPECIAL FEATURES OF THE BUILDING
> Largest European development center for biotechnology
> Integration of biological analytics, process development, and drug manufacturing for clinical trials
> Integrated project management & office space based on the Smart Working principle
> Coordination of numerous involved companies

DREES & SOMMER SERVICES
> 360-degree analysis, project management, office services
> S-curve tracking for target vs. actual project progress
> A-curve tracking for workload balancing
> Subproject dashboards for controlling phases such as qualification,
> Document control matrix / LODs, standard workflows