Project

Nordmark won the market production contract for a microbially manufactured drug substance. D&N supported the tech transfer and commissioning.

Our Services

• Project management
  – Drafting the process transfer plan
  – Project organisation jointly with the Nordmark project manager
• Process modelling
  – Modelling of the manufacturing process: Capacity and staff utilization
  – Personnel planning for production
• USP production support
  – Creating and optimizing manufacturing instructions
• Production engineering support
  – Optimisation of process equipment
  – Compiling spare parts lists incl. risk assessment and prioritization
  – Spare parts procurement organization incl. technical clarification with suppliers

Michael Kurdum, Director Biotechnological API Production

„Thanks to their extensive expertise, the D&N team supported us during process transfer and commissioning in all areas in which we needed assistance. Together, we were always able to overcome personnel bottlenecks.

D&N immediately took care of emerging problems and challenges and worked closely with us to drive the project to success.

The consultants were able to get involved in the project team very quickly, because the personal chemistry was right from the start.“