Highly specialized skills and experience are required to make drug products that are safe for one of the most intricate and sensitive communities in the world, the human body. Billions of dollars are spent each year to research and develop new and improved therapies meant to defend, mend and extend human life. Once a therapy advances to a stage that inspires commercial development and investment, it’s critical that the facility where that therapy will be manufactured is designed to mirror the level of sophistication of it’s final human host. Herein lies the role of the Process Architect and “their process” to extract, understand and organize the many requirements into a compliant matrix of compartments that emulate regulations, operating steps, safety and efficiency. A good Process Architect makes it their mission to pool the regulatory guides, engineering data points and process information available to make sense of your process, architecturally and operationally.
While there aren’t many Process Architects in the world, IPS has one of the deepest and best Process Architecture teams in the biopharmaceutical engineering business.
Tom Piombino, one of our leading Process Architects, has over 20 years of experience and is regarded as a subject matter expert. Contact him to learn more about how we can help you achieve your project goals.