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Patheon Inc. services
Drug Substance
Comprehensive Development and Clinical Manufacturing Services for Biologics
Your molecule has the power to change lives and shape the future. Let our biologics experts show you how to speed development and unleash the potential of your discovery. Patheon, by Thermo Fisher Scientific, offers you the flexibility and speed to help you get there ahead of schedule while maintaining the highest quality.
Process Validation and Tech Transfer Services
In late clinical phases, and as part of the establishment of your commercial supply, Patheon provides a complete validation package according to regulatory and cGMP guidelines.
Commercial Batch Manufacturing Services
Commercial manufacturing under full cGMP conditions with speed, efficiency and exceptional quality, plus flexibility to adapt to changes in your market and mission. At Patheon there is no such thing as good enough. We will never stop working to optimize and intensify your process to increase outputs and reduce timelines and capital expenditure. We are continuously making investments in capacity, infrastructure and technology. Our goal is to lower your cost of goods while maintaining the highest standards of quality. And to earn your business year after year with hard work and innovation.
Product Development
Preformulation Screening Services
With speed and efficiency, evaluate the properties of your biologic for a clear understanding of the path to Phase I clinical studies and beyond. Patheon gives you access to the full breadth of advanced analytical technologies and preformulation services.
Formulation Development Services
Get your discovery to the proof of concept milestone with speed and efficiency while laying a firm foundation for future commercial success. Patheon has helped clients receive more NDA approvals than any other CMO.* By pairing this experience with a full range of analytical, formulation and dosage form technologies and solutions, Patheon can tailor a lean drug development program precisely suited to your molecule and business. One that will accelerate your project to first-in-human studies, and beyond when fully integrated with our comprehensive commercial supply and drug substance services.
Manufacturing Process Development Services
Build quality and robust repeatability into your manufacturing process. Do it during early phases to accelerate through later phases and into commercial production upon approval. Because our capabilities span the full breadth and depth of the biopharmaceutical development life cycle, because we have experience at every stage, we know what your process needs to succeed today and tomorrow. With Patheon, you’ll get a process that is reliable, efficient and built to deliver repeatable quality when you bring your product to market.
Development Services - Drug Substance - Small Molecule API Development
Small Molecule API Development Services
At Thermo Fisher Scientific, our people pride themselves on solving your API development challenges. Our objective is to help speed your molecule through early phase trials and prepare you for commercial success, faster. Whether you start working with us in early phase or late, we draw on years of experience and deep expertise to achieve industry-leading performance. Whether you need small quantities of API for initial development work or many kilograms for a late phase trial, you can reduce the risk and raise the bar on quality of small molecule development with a partner whose reputation is built on both quality and excellence in chemistry.
Route Scouting Services
Establishing the best synthetic route for your molecule is the basis for a reliable supply throughout the product’s life cycle. During route scouting, the following considerations are important when selecting the optimal pathway: Safety, Efficiency, purity and costs, Ease of optimization and scale up, IP review, Security of supply of raw materials, Impact on waste and the environment.
Process Development Services
Broad experience and access to the latest technological capabilities are essential for today’s increasingly complex API development and manufacturing. By partnering with Thermo Fisher Scientific, you’ll work directly with scientists with deep chemistry knowledge and many years of experience in successfully supporting early and later phase clinical development programs. Our experts offer you cutting edge technology from start to finish in multi-step chemical synthesis and from traditional to complex manufacturing.
Analytical Development & Validation Services
Repeatable, High Quality and Robust Process Design; We offer an in-depth understanding of reaction profiles and the quality and physical form of starting materials, intermediates and the final product are critical components of API (active pharmaceutical ingredient) development. To support route scouting and process development activities and accelerate your clinical programs, we provide a comprehensive range of analytical services.
