Technology transfers, for scale-up or moving a project between facilities, are part of the normal course of business. But at Patheon we see them as an opportunity to use our integration and efficiency to give our customers a strategic and financial advantage. We deploy a dedicated team that possesses the experience of thousands of transfers to bring the highest level of technical and regulatory expertise to your project.
Even when the transfer is due to an urgent customer situation, Patheon can execute it quickly and effectively to get your project back on track and preserve the flow of product. In all cases, we are driven by your deadlines, flexible in our approach, and determined to get it right the first time every time.
In 2008 and again in 2010, The European Outsourcing Awards recognized Patheon for executing the most effective scale-up and technology transfer. Read more about what our team can do for you in the following case studies.
Case Study: Large Tech Transfer Earns European Outsourcing Award
The Challenge A multinational pharma company managed an outdated facility that was unable to keep up with new standards and regulations. Rather than spend time and capital making updates, they selected Patheon to provide long-term manufacturing. The challenge was to transfer 33 solid dose products, 8 formulations, 11 packaging formats and 85 regulatory variations within three years and without interruption of supply.
The Solution To streamline the tech transfers, three Patheon facilities were op¬erated as one. Our Patheon Advantage™ approach to project management integrated quality report¬ing systems and managed daily operational details. A “single-point relationship” was established to simplify the decision making for this complex challenge.
The Outcome Patheon aligned the strategic business needs of both parties, and achieved all key metrics of success:
- New standards and regulations were exceeded
- Regulatory approval times were shortened
- No quality issues
- No out of stock situations or supply chain issues
All 33 tech transfers were completed on time and within budget. Patheon’s efforts were recognized by the 2008 European Outsourcing Awards as the Most Effective Scale-up and Technical Transfer.
Case Study: Urgent Technology Transfer Preserves Global Supply
The Challenge A new customer was having critical quality compliance issues with another CMO. They contracted Patheon to manufacturer their sterile lyophilized drug product which was marketed globally, but had only previously been manufactured in the United States.
The Solution Due to the deteriorating situation with the other CMO, the timeline for the tech transfer was extremely short. Patheon provided a dedicated tech transfer team that worked as one with the customer to execute each aspect of the project: validation of the non-compendial analytical methods, transfer of the manufacturing process, equipment design and qualification, process validation batches manufacturing, and a stability study on the drug product.
The Outcome Due to the efficiency of Patheon’s unique one-on-one approach to project management, we were able to complete the tech transfer in just 11 months – 6 months less than originally agreed – providing the customer with an uninterrupted global supply.