Successful implementation of pioneering new GMP building
io’s services in planning and implementation made an influential contribution to the success of the newly opened Launch & Technology Center (LTC), a facility designed to further strengthen Merck's global competitive position. Merck entrusted io not only with management of the whole project, but also with overall responsibility for GMP layout planning, implementation support, as well as complete qualification and validation support in accordance with EU GMP and FDA standards.
Merck consolidates its activities at a single site
Merck’s new building in Darmstadt marks an important step towards transforming research and development projects in the healthcare sector into commercial production and accelerating the market launch of new medicines. Particular attention is being paid to further developing therapies using small-volume molecules, which are able to penetrate the body’s smallest structures due to their low molecular mass.
The new building allows Merck to consolidate its SVP activities at a single site, thereby specifically improving the efficiency of all associated processes.
On a functional level, the new Launch & Technology Center provides a total floor area of around 14,000 m², providing plenty of room for modern laboratories, flexible facilities for tablet production as well as the processing of highly potent active ingredients on a medium scale – as well as the necessary office space. All facilities are closely integrated here to enable maximum efficiency.
Key Facts
Client
Merck KGaA is a German chemical and pharmaceutical company with its headquarters in Darmstadt. Originally founded in 1668, Merck has gradually grown into a global company. Their workforce of around 57,000 people develops genome-editing technologies, discovers ways to treat diseases, and provides applications for smart devices.
The challenge
- Stringent regulatory containment requirements (EU GMP and FDA standards)
- Interface management between process technology, automation, clean rooms, MEP, and qualification, whilst adhering to a tight schedule throughout the entire project life cycle of the Launch Technology Center
- The LTC enables accelerated market launch of new healthcare products through a more efficient transformation of R&D results into commercial production
- Achieving maximum sustainability targets to reduce the carbon footprint with consistent planning and implementation
Solution
- Sustainable building design featuring 1,600 m² of solar panels, geothermal energy, wastewater management and roof greening
- Flexible, tightly integrated spaces for laboratories, production and offices across approximately 14,000 m²
- Close operational integration into the Merck LTC team, including schedule, quality and cost control with a strong on-site presence
