by Jeff Lewis, PE, Ryan McDonough, PE, and Eddie Skillington of DPS Group
In the engineering and design world of high-tech industries, commissioning, qualification, and validation (CQV) is an important part of building fully functional pharmaceutical manufacturing facilities. Major drug companies have this down to a science.
The CQV story can often be quite different for younger companies pursuing novel therapies. Many have emerged from a research and development lab or academic environment, often with government or venture capital funding, expecting results to happen sooner rather than later. Researchers specialize in discovery over delivery. In most cases, they haven't yet needed to consider the requirements of designing and building facilities to manufacture products at scale, nor what it may take to qualify the facility to do just that.
Working side-by-side with these novel drug companies and researchers, experienced engineers can identify and overcome hurdles that arise when facing the transfer from research to production scale. Since these companies' familiarity with facilities for pharmaceutical manufacturing can range from expert to novice, everyone involved has to be in the trenches together.
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