Ensuring the successful completion of a QC laboratory expansion

Alba Project Group was engaged in the final phase of a laboratory expansion project to help secure completion and support the transition to operational readiness.

Background

A leading global CDMO within biopharmaceutical development and manufacturing is expanding its production capacity at its Danish facilities. As part of this, the company needed to expand its QC laboratory in order to meet the needs of current production, which has an increasing and more complex need for analyses than before, while also supporting upcoming production.

The company had plans to build the first part of a larger laboratory campus over time, and the project was approaching completion when Alba Project Group was asked to help bring the project across the finish line and support the transition with the handover to operational readiness of the laboratory.

Our Approach

The project status was mapped during the first week, and a gap analysis was presented to management in relation to the requirements for obtaining approval of the laboratories from the Danish Medicines Agency.

The organization was reviewed and optimized to support the functions, resources, and competencies required to complete the project. Structures for documentation management, punch lists, and status reporting were established and executed in collaboration with the client and the suppliers responsible for the remaining installations and tests. Risk management and regular planning meetings were implemented to ensure close follow-up on the remaining outstanding items.

Communication between all stakeholders was critical to optimize at this stage in order to close the remaining gaps. In close collaboration with contract management, handover items were followed up to finalize the remaining contracts.

The Result

A full overview of recommended future upgrades and changes to the buildings was established and communicated to the operational organization.


A complete Lessons Learned / project learning process was carried out with all individuals who had worked on the project. A joint workshop was conducted to prepare a final report and a concluding stage-gate presentation for both the future project teams that will continue building the campus and the steering committee.

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