Nordmark Pharma
Capacity expansion for a biological active ingredient

Challenge

Nordmark needs to increase the production capacity for a biological drug substance in preparation for market launch and to ensure all regulatory requirements are fulfilled for market production.

Solution

  • Expansion of the existing pilot plant for commercial production
  • Tripling production capacity through extension and expansion into an existing building
  • Minimum manufacturing interruptions during retrofit

Our Services

  • Concept design for the production expansion, including
    – Integration of process technology, architecture and utilities
    – Process modelling and optimization of process flows and CAPEX
    – Retrofit concept
  • Process planning together with Nordmark (Basic and detail design)
  • Project management during planning, deconstruction and rebuilding activities

Dr. Silke Hüttler, Head of Biological API Production

„D&N supported us in all project phases starting with concept design. Thanks to D&N‘s planning experience and GMP expertise, we were able to develop a cost-efficient expansion and retrofit solution for our existing facility.

For the transition from clinical manufacturing to commercial production, we jointly modelled and optimized process flows and schedules. D&N contributed valuable methodological expertise. Together with our team, D&N always identified good solutions and advanced the project, even during difficult project phases – such as deconstruction.

We look forward to continuing our collaboration with D&N on this and further projects.“