References

We are proud of our large customer portfolio and of the innumberable projects we have realised for more than 30 years.

The references below provide only an excerpt of these projects. They emphasize our broad expertise in the fields of biotech and pharma. Our cohesive project teams are always geared to benefit our customer – for projects of any size.

Monoproduct, Yeast production, primary recovery and intermediate filling

• Module I within the Ibex® Solutions complex from Lonza on 1'200 m2 production floor
• CD, BD EPCMQ Qualification in 22 months
• Media Preparation, powder injection systems, small media preparation
• Inoculation, seed, production fermenter, Microfiltration and Filling into bags

Biotech Production Center for antibody-drug conjugates (ADCs), Basel, Switzerland

• Conceptual Design and EPCM Contractor for Process part
• 2 production lines

Other projects: Conceptual Design for MAB Production Facility in Basel. Engineering Services for "TP Expand" in Penzberg, Germany.

Multi-product Cell Culture Facility, Incheon, Korea

• Upstream suite (USP) with six 5'000 L production fermenters
• Downstream suite (DSP) highly flexible concerning purification methods
• Drug formulation and a fill & finish suite

For the entire process control system the ANSI/ISA S88.01 standard was consistently applied and implemented.

Biotech Building of Werthenstein BioPharma GmbH, Schachen, Switzerland

• Multi-purpose facility / cell culture facility
• Basic and detailed design, construction management, commissioning and qualification.

The facility was upgraded and expanded several times according to changing needs.

Single-Use Cell Culture Facility of LFB Biomanufacturing (MAbgène), Alès, France

• Small scale production (upstream and downstream)
• Single use technology for most of the process equipment

Conceptual and detailed design for USP and DSP areas. Site Master Planning and Site Development.

Plasma Processing Facility (NBF245), Marburg, Germany

• New production building

Other projects: Engineering and realisation of a DSP facility for a coagulation factor in Marburg. Liquid pharma storage farm in Berne, Switzerland

Industrial biotech facility, Brindisi, Italy

• Pre-Basic Design for the revamping of an API production plant (2 x 80 m3 fermenters)

Other projects: Revamping of two biotech production buildings (fermentation and purification) in Hoechst, Germany (Aventis).

Human Vaccine Plant of IDT Biologika GmbH, Dessau-Tornau, Germany

• Aseptic vial filling line in isolator technology
• Lyophilisation with automatic loading
• Washing and sterilisation of stoppers and caps

Other projects: Filling facility for ampoules, vials and syringes. Vaccine facility.

Mammalian Cell Culture Production Facility, Fenil-sur-Corsier / Vevey, Switzerland

• Basic and Detailed Engineering of process plants (upstream / downstream) and CIP/RIP; construction management and qualification support
• Two independent production lines for biopharmaceuticals

Initial steps: Front-end engineering for rebuilding and expansion of production facility.
Feasibility and site evaluation studies for Merck prior to the acquisition of Serono.

Facility for Highly Active Substance (HAS), Dessau-Rosslau, Germany

• Fermentation and purification of a highly APIs in isolator units
• Key process equipment: incubator, fermenter, precipitation & harvest unit, centrifugation, ultrafiltration, chromatography

Process transfer from laboratory to production scale and isolator mock-up studies.

Multipurpose Cell Culture Facility of Merckle Biotec GmbH (Teva), Ulm, Germany

• Three story building with process areas for upstream and downstream processing
• The perfusion bioreactors medium feed and harvest using disposable bags
• Engineering, Construction Management, Commissioning & Qualification
   

Fast track green field project: less than 2 years from project start to completion

Multipurpose Biotech Facility, Bovenau, Germany

• Processing area on two floors (4'500 m²)
• Class D, C and B clean rooms
• Biopharmaceuticals and plasmid DNA based on bacterial fermentation 

Facility upgrades for yeast fermentation (Pichia pastoris) and Preparative HPLC.

GMP Production Facilities for Biopharmaceuticals (REX III), Laupheim, Germany

• 500 L and 2'500 L cell cultures fermenter lines for batch, fed-batch and perfusion
• Flexible DSP suites for all kind of downstream processing steps

Responsible for basic and detailed design of process equipment and utilities, procurement, expediting, FAT, construction management and commissioning.

Site Capacity Expansion (SFMP), Huningue, France

• Feasibility study for site development based on various scenarios
• Single use cell culture plant

Other recent studies: Facility for viral products in Basel