Clinical Trial Production Support

The Norwich site includes a specially designed CLESTRA clinical manufacturing facility. This is a self-contained module within a module with two individually controlled manufacturing suites within it. Special features include:

• Two separate sides validated to run different products simultaneously without cross-contamination due to facility design and one-pass air systems.
• Product and equipment flow into each side of the facility is separate from personnel flow, further preventing cross-contamination between suites or from outside the desgined intermediate potency CLESTRA clinical manufacturing facility.
• This intermediate potency facility is designed with movable walls that allow flexibility to the customer; i.e., a single large space can be created for one unit operation or several smaller spaces for multiple unit operations.

This facility is designed specifically for small-scale production to support clinical trials -- from bio-batch to phase III scale -- and is subject to the same stringent maintenance standards as our larger facility. Combined with our commercial production capabilities, customers have the unique opportunity to qualify their clinical trial production and their commercial production all in the same building, shortening overall drug development times.