Technology transfer

The transfer of technology is well known to be one of the most problematic issues in the development of a new drug process. This process involves the passing over of innumerable data and of vast knowledge where even the smallest detail can be critical to the success of the process. At Hovione, we have recognized the difficulties involved in technology transfer and have identified 4 fundamental key factors to guarantee its success: proximity and good communication between the 2 parties, past experience, a multi-disciplinary team skilled in project management, and a set of validated procedures on technology transfer.

Our Technology Transfer Center (TTC), as its name indicates, serves the principal role of achieving successful technology transfers: firstly, from the Customer to Hovione´s TTC, our latest facility in New Jersey, and, secondly, from there to our manufacturing plants in Europe and Asia. The TTC brings Hovione closer to North American customers, enabling a much closer proximity and ease in the relationship. In the initial stages of a project, customers are welcome to stay at the TTC and accompany the project as they see fit and necessary. The TTC is a well-equipped and fully-staffed chemical laboratory specifically designed to address the needs of early phase projects and to extend Hovione’s support to customers. A state-of-the-art cGMP laboratory, kilo lab and pilot plant supplement the total range of services we offer, providing a fast and high-caliber response to customers’ immediate needs.

The technical capabilities of the TTC´s facility mirror those of Hovione´s commercial production facilities, ensuring that our objective – the seamless and cost efficient transfer of a process between the US and our plants in Portugal and Macau – is achieved. The facility is also fully integrated with Hovione´s global quality network; operating under the same quality system, corporate operating procedures, company culture and project management approach, we can quickly achieve routine production of new molecules in large quantities and get it right first time. This global quality system also enables our customers to view real time data and receive regulatory support for on-going production at all our manufacturing plants.


2 successful technology transfers achieved in 2004

In 2004, less than 2 years after the TTC´s opening, two new customer projects were successfully transferred from the US to both manufacturing plants; one went to Portugal, the other to Macau. In both cases, a multidisciplinary team from the manufacturing site comprising staff from Production, Analysis and Quality Control, was transferred to New Jersey to assist the last campaign of the process at the TTC. This same team was responsible for the project back in Portugal / Macau, maintaining a high degree of support and contact with the TTC chemists. The culturally different teams, speaking in human terms, worked together seamlessly, thanks to Hovione´s philosophy of "one Company, one Culture" - both teams followed the same set of procedures, the same approach to project management, and shared the same attitude towards difficulties and challenges. The result is: the validation campaign was completed earlier than scheduled, and the yield obtained was higher than expected!


Technology Transfer