When you think about why you should choose Patheon for your clinical supply of API, think about the early-phase pressure to be fast and efficient. Also consider late-phase pressure, when it’s still about time and money but so much more of both has been invested. Then add a hefty sense of personal responsibility to protect a successful project, and the anxiety that early-stage focused decisions could lead to costly changes in later stages.
Even during preclinical process development, everything Patheon does is with the successful commercial launch of your finished product in mind. That means your process will efficiently meet your early clinical supply needs, seamlessly scale-up for late-phase trials and then deliver the kilos you need to establish and maintain a reliable, high-quality commercial supply.
Clinical Supply Designed for Commercial Success
Very few other CDMOs offer expertise in both early-stage API clinical development and commercial supply. Fewer still are also global leaders in finished dosage form development and manufacturing. Finally, no other company offers a wider range of services and technologies in all of these areas, which means that no other company is better equipped to meet your specific needs. With Patheon you’ll have the efficiency and simplicity of a single strategic partner that can help you take your discovery all the way from molecule to market.
- Flexibility of a seamlessly scalable process
- Capacity range from 1 kg to thousands of metric tons
- Comprehensive array of technologies, services, and proprietary solutions
- Established relationships with the most reliable suppliers of high-quality raw materials
- Expertise in all aspects of transforming a discovery into a successful product
- Peerless quality systems and track record of more than 2,000 successful first-batches
- Exceptional reputation in the industry and with regulatory agencies around the world
- Full regulatory support with CMC documentation
Two State-of-the-Art Facilities. Everything You Need.
Your early-stage clinical supply will be produced at our state-of-the-art ResCom® (Responsive and Committed) research and development center in Regensburg, Germany. Living up to its name, this cGMP/ISO facility is 100% committed to the development and optimization of innovative processes that deliver exceptional yields and reliable quality at any scale. ResCom® is staffed by a team of 35 top-tier experts with a full range of technologies and comprehensive analytical services at their disposal. They have a collaborative approach that is responsive to our customers’ needs and concerns.
For late-stage clinical trials and beyond, your supply of API will be manufactured at our cGMP commercial production facility in Linz, Austria. This site, only a couple hours away by car, offers the same solutions as ResCom® for seamless scale-up and an abbreviated tech transfer process. Patheon offers you the means to streamline and coordinate every aspect of developing a successful pharmaceutical product. By partnering with us you unlock the potential to accelerate development and simplify your supply chain while maximizing the flexibility, quality, and security of your supply.
Choosing Patheon for your API process development and clinical supply today will pay dividends again and again tomorrow.