Supply risks in the pharmaceutical industry can come in the form of a consent decree by a regulatory agency, the closure of a vendor's operations, or even a natural disaster. These unforeseen events don't just put your business in jeopardy, but can also have a significant impact on patients.
Patheon is a recognized innovator in risk mitigation. Our sterile backup supply program was the first of it's kind in the industry. Made available to Patheon customers and non-customers alike, it was a well-received backup plan for pharmaceutical companies who saw their outsourced sterile manufacturing under escalating pressure from regulatory agencies.
At the heart of our excellence in risk mitigation is the excellence of our operations. Since 2007 our facilities have undergone 102 regulatory inspections, with 30 resulting in zero observations. That's perfection in nearly 1 in every 3 inspections. Also, Patheon is the only sterile drug manufacturer with no warnings from regulatory agencies.
Experience gained over thousands of projects gives Patheon the ability to prevent problems before they occur. And thanks to our fully integrated global network of facilities, and redundancies in our operations, we are prepared to make quick transfers thus eliminating the chance for a product supply interruption.
Case Study: Rapid Response to an FDA Emergency Request
The Challenge Our client had received an emergency use authorization for their product from the U.S. FDA. Speed to production to meet this urgent increase in demand was critical. Patheon was chosen for the project based upon our readily available capacity and resources, as well as our expertise in sterile production.
The Solution The first step was to immediately transfer, qualify and validate the product to the Patheon Ferentino plant for the emergency use supply. In parallel a second site, the Patheon Monza facility, was qualified to ensure a robust commercial supply moving forward. The keys for success were the open communication between the client’s and Patheon’s dedicated teams, as well as the seamless integration of the Patheon sites. This fluid collaborative environment simplified the alignment of operational and regulatory details. These two complex tech transfers were accomplished with the ease of one, even given the urgent timeline.
The Outcome Both tech transfers, qualifications and validations were completed within six months of the first meeting. The emergency use supply and commercial supplies were released and delivered on time and on budget. In fact, due to Patheon’s available capacity and resources, the client was able to save on validation costs and capital expenditure while answering the U.S. FDA request without delay. And what began as a single project, quickly grew into an ongoing working relationship.