Supporting the expansion of GMP manufacturing capabilities through close collaboration.
A solid foundation for decision-making at executive management level was needed to determine how to establish additional commercial GMP manufacturing capacity to support the expansion of our capabilities, our future growth, and our product portfolio.
This was the request from the client as part of the company’s strategic ambition to support its journey towards full commercial production. To support this important step, Alba Project Group was engaged based on its experience within GMP facilities, process design, and life science projects, to help establish a reliable and well-documented foundation for the next phase of the clients development.
Background
The objective was not only to increase capacity, but to ensure that the future facility would support their continued development as a leading CDMO within advanced therapies.
Our Approach
Whining Dog, contributing strong expertise within GMP facility design and life science environments.
A two-day on-site workshop was conducted at the clients facility in Spain, focusing on aligning process
requirements, facility layout, and future production ambitions. Through close collaboration and active involvement of key stakeholders, the workshop enabled efficient clarification and alignment of the
required capabilities.
During the workshop, the required processes and workflows were mapped in detail, and a draft layout forthe future facility was developed, allowing stakeholders to visualize the setup and validate key design assumptions at an early stage.
As part of the continued collaboration, Alba Project Group and Whining Dog later returned to the site to further refine the developed facility concept, ensuring alignment between process requirements, architectural design, and the clients long-term strategy for expanding its manufacturing capabilities.
The Result
The collaboration resulted in detailed process mapping, a validated facility layout, and a clear and structured decision basis for establishing a future commercial GMP manufacturing facility.
The proposed solution enabled a potential increase in manufacturing capacity of more than 200%, while also expanding key supporting functions including DP filling, Quality Control, Process Development, and Warehouse capabilities.
Cost and budget assessments were carried out with involvement from Alba Project Group’s procurement team. This ensured that the proposed setup was evaluated from technical, operational, and financial perspectives, providing a well-balanced foundation for management decision-making.
Most importantly, the project provided the client with a solid foundation for the planned expansion of its GMP manufacturing capabilities, ensuring that future investments can be made based on a well-aligned technical, operational, and strategic framework.
“This was a very strong collaboration for us. The high level of competence across the team enabled detailed and technical discussions throughout the project, which ultimately allowed us to deliver a result that exceeded our initial expectations. We truly appreciate the constructive and professional cooperation.”
— Per Poulsen, Head of Project Management at Alba Project Group
Through close collaboration between the client, Alba Project Group, and Whining Dog, the project established a realistic and scalable path forward, supporting the clients ambition to strengthen its position as a CDMO within advanced therapies production and future commercial supply.
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