Key References

Planning of a plasma fractionation with 650,000 l / 1 million l (expansion) per year; basic fractionation, purification, fill & finish, products: IVIG, albumin, FVIII, each in different concentrations. Planning as a "sandwich concept", production-centered arrangement with the supply below and HVAC above.

Planning of a production plant for endoglycosiadases (and in future also mRNA). Microbiological plant (yeasts and bacteria) with 30l / 300l (after expansion) fermentation volume. Planning as a classic upstream-downstream plant with single-use technology for fermentation and purification.

Concept design and engineering for a new production facility for cell therapies on an area of 1,000 m² (brownfield). Production of dendritic cells, CAR-T cells and lentiviral vectors. Main features: Flexible production - cell suites, production area for lentiviral vectors, QC labs, storage, cold chain management.

Greenfield production facility for sterile injectable products. Vials for liquid products (11 million annual capacity), lyophilized products (4 million annual capacity), prefilled syringes (30 million annual capacity), pens (30 million annual capacity).

This 20,000 m² greenfield is an important part of Daiichi Sankyo’s expansion of the site in Pfaffenhofen and its integrated value chain for production of ADCs. It includes cold and ambient storage areas, secondary packaging areas, a freeze-drying and aseptic filling area (Phase II), and all necessary ancillary areas for a high-tech production. cgilse was responsible for all project implementation steps in phase I – from design over construction to commissioning.

The project concerns a new facility for production of ADCs („antibody drug conjugates“, innovative products for cancer treatment), including Drug Substance (API) and Drug Product (final product). cgilse and its partners are ensuring that this 28,000 m² greenfield production facility is designed, constructed and completed on time and within budget. cgilse is the EPCMV contractor and is responsible for all engineering steps, procurement, construction management, commissioning, and qualification and validation work.

Daiichi Sankyo’s production facility for monoclonal antibody (mAb) and ADC (Antibody Drug Conjugates) in Pfaffenhofen, Germany. cgilse serves this 13,000 m² greenfield facility as the EPCMV contractor (engineering, procurement, construction management, qualification/validation). The building hosts several production lines for mAb’s (e.g. for commercial production, clinical trials, process development and a pilot plant) featuring “Single-Use”-technologies, as well as two production lines for Bioconjugation of ADCs.