Sartorius CellGenix
Commissioning and Qualification for Microbial Facility


Project

Sartorius CellGenix expanded its Freiburg site by establishing a state-of-the-art cleanroom-based microbial production facility for cytokines and growth factors, increasing manufacturing capacity for cell and gene therapy components.

D&N played a key role in the commissioning, qualification, and operational readiness of the new facility. Beyond ensuring technical readiness, the team helped establish end-to-end operations, supporting upstream and downstream processing, fill & finish, quality control, and logistics from both technological and operational perspectives.

Our Services

Design and Engineering Documents

  • Process Flow Diagrams (PFDs)
  • Single-Use-Concept
    e.g., Design Principles Guidance Container List, End-to-End Single-Use-Equipment Planning, Deployment and Handling
  • Production Logistics Concept

Design and Engineering Documents

  • Standard Operating Procedures (SOPs) and Work Instructions
  • Intralogistics Transport Concept
    with Product, Material, Equipment and Waste Flows
  • Process Control Strategy
  • Validation Plans and Quality Management (QM) System Documentation
  • Bill of Materials
    including assignment to storage and production areas and hazard classification

Florian Egner, Engineering and Operational Leader

„Working with D&N on our Operational Readiness project was a great success. From the outset, D&N team members were perceived as an integral part of our project team, contributing extensive manufacturing expertise, high motivation, responsiveness, and reliability.

D&N quickly understood our requirements and the customer’s voice, consistently demonstrating a consultative approach through active listening, collaboration, and practical solutions. Even under changing priorities or resource constraints, the team provided flexible and targeted support.

Their high level of expertise, deep process understanding, and ability to leverage knowledge and networks to solve complex challenges were key success factors. The collaboration was always professional, trust-based, and highly enjoyable on a personal level.“