Case Study Manufacturing

Locate Customized Manufacturing Capability

Benefits of Case:

Identified CMO to accommodate customized manufacturing equipment in sterile manufacturing suite with adaptable facility design
Met timeline for Phase III clinical trial manufacturing

Background and Challenge:

Without success, the Client searched for nearly a year to find a CMO that would accommodate a manufacturing process requiring a large piece of customized processing equipment to be placed under Class 100 laminar air flow conditions between the aseptic filling and capping processes.

PharmaDirections Strategy:

PharmaDirections examined PharmaDirectNet™ network of CMO’s and identified a sterile injectable CMO with adaptable facility design. PharmaDirections educated and guided the CMO on how their facility could be reconfigured to accommodate the unique process without disrupting the integrity of their normal aseptic process manufacturing operation.

The Objective:

Identify a CMO that would accommodate a unique process
Design facility modification to maintain the integrity of the aseptic process
Obtain agreement on modifications and validation of facility changes, technology transfer of processes and methods as well as process validation to meet Phase III clinical study schedule

Value to the Client:

Without the industry knowledge and contacts, the sponsor would not have found a CMO willing to accommodate their process
Avoided the cost and time of constructing their own facility to meet their product manufacturing needs