Challenge

A leading global pharmaceutical/biotech company and a Fortune 100 top employer needed to convert a clinical supplies/R&D pilot plant to an HPAPI/ADC flow chemistry facility so that they could continue to provide the lifesaving medicines that their patients need. The demolition of various existing equipment and the installation of new equipment was confined to a limited space.

Solution

Valdes was able to accommodate the many moving pieces of this project in a confined space and deliver a thorough plan for the demolition, rearrangement and installation of pressure vessels and agitators, chromatography column and pumps, process instrumentation, power wiring/conduit, vacuum, buffer prep transfer lines, and associated utilities, including nitrogen, compressed air, propylene glycol supply/return, fresh water and hot water (lab), water for injection (WFI), and breathing air. Architectural support and HVAC activities were also provided to accommodate modifications and the new room layout.

Impact

Valdes performed the front-end engineering design and the detail engineering to scale up the existing infrastructure for greater production of active pharmaceutical ingredients (APIs) and antibody-drug conjugates (ADCs) via flow chemistry from the original batch-production technology.

Services

Architecture

Mechanical

Electrical

Process

Project Management