Case Study

Small Molecule Facility

Challenge:

A contract development and manufacturing organization (CDMO) client was planning to upgrade their site to allow for the contract manufacturing of bulk small molecule Schedule 2 active pharmaceutical ingredients (API). They had a couple of ideas of how to incorporate this upgrade into their current facility, but needed evidence to support which option would be the fastest path to market, minimize interruptions to existing operations and offer a long-term upgrade to existing infrastructure.

Solution:

Valdes evaluated the two options presented by the client in depth to determine the best design given the criteria. The first option was to install the manufacturing facility into one of the bays of an existing building and the second was to construct a stand-alone manufacturing facility. Valdes staff conducted an intensive site investigation to determine what existing infrastructure could stay or be upgraded and which had to be completely replaced.

Impact:

Through these investigations, Valdes helped the client make a determination about how to proceed with incorporating the new bulk small molecule Schedule 2 API manufacturing into their facility based on which option optimized the existing infrastructure and resources. Valdes also provided a conceptual plan for the facility as it could be laid out in the existing building, as well as a conceptual plan for a stand-alone facility located near their existing buildings.