Bibitec
Project Management - Tech-Transfer and GMP Readiness


Project

The cell culture CDMO BIBITEC, a subsidiary of Nordmark Pharma, successfully commissioned its new GMP API production facility at the Nordmark plant in Uetersen in 2025.

D&N and network partners assumed project responsibility for the final steps of the project:

Achieving inspection-readiness and approval of manufactring authorization.

Our Services

  • Project management including scheduling and cost control
  • Equipment qualification oversight
  • Planning and monitoring of the following activities:
    – Analytical method validation
    – Adaptation of the QA system
    – Integration into the site infrastructure
    – e.g. goods receiving and control, warehousing, ERP integration
  • Inspection preparation including self-inspection

Dr. Jörn Tonne, CEO Nordmark Pharma

„Over the past five years, we have worked more closely with Gregor Dudziak and his team than with any other consultant to date.

I was particularly impressed by how D&N applied its extensive knowledge of the biotech industry, markets, processes, and technologies to develop production concepts for our company.

Furthermore, Gregor Dudziak took on operational responsibility when our company faced staff shortages.

A clear recommendation, especially for midsized companies and start-ups.“