The pressure to file an IND makes accelerated Phase I safety testing a priority. With the Quick to Clinic program, Thermo Fisher Scientific can deliver your large molecule drug substance for First-in-Human studies in as little as 12 months. Now you can meet important milestones – such as filing the IND – or secure additional funding with all the confidence your project needs and, we can supply. Because helping you reduce the time it takes to get your discovery to the patients who need it matters, our Quick to Clinic for Biologics is made with speed and flexibility.
Whether your company is built on a single molecule or you’re a global pharmaceutical leader, you need fast, cost-effective and scientifically-based insights during early-phase development. Patheon can provide you with customized early development strategies and technical solutions to solve complex development challenges.
The challenges, risks and costs of bringing complex large molecule products to market are growing exponentially. Gaining a competitive advantage is more difficult. Drawing on 20 years of biologic experience, Thermo Fisher Scientific offers you flexible, end-to-end solutions and expertise in development and manufacturing combined with advanced technical capabilities.
Take a big picture approach to small molecules. Ensure that you always have the exact resources and expertise you need, especially for your most difficult to manufacture compounds. With Patheon you’ll have access to a vast array of small molecule API capabilities in Europe and the United States. Reactors ranging from 30 L up to 16 m3, comprehensive analytical services and expertise in all the chemistries you expect, as well as many unique solutions and innovative technologies you won’t find anywhere else. It’s a big-picture approach that delivers high-quality API via a seamlessly scalable process that will rapidly achieve your goals at each phase of development while laying a sound foundation for your future success.
Patheon, part of Thermo Fisher Scientific, is transforming the way pharmaceuticals are made with a simplified, end-to-end supply chain for pharmaceutical and biopharmaceutical companies of all sizes. Drug substances and drug products. Development and manufacturing. Small and large molecules. Sterile, oral solid and softgel dosage forms. Patheon offers a comprehensive range of services spanning all phases and scales that is wider and deeper than any other CDMO. Gain instant access to a fully integrated global facilities network.
Outsourcing API development can save time and money. Or it can waste them. Since the difference between these outcomes stems from your choice of a development partner, careful consideration of these eight critical areas is required to help ensure a fast, smooth API development process.
Learn about Patheon’s full dose form capabilities and technologies, including various tablets, caplets, chewables, powders, softgels, and more. Leverage Patheon’s broad range of expertise, from pre-formulation through commercialization, to help your project achieve success.
Your molecule has the power to change lives and shape the future. Patheon is the company that offers you the agility and speed to help you get there ahead of schedule while maintaining the highest quality. We bring deep scientific expertise to every challenge and our proven track record of scaling up biologics help ensure you gain cost and time savings at every stage of the biologic development process.
Take months off the development timelines of your large and small molecule discoveries. With Patheon Quick to Care™ you can combine your drug substance and drug product development, demand planning and clinical trial supply execution into a single customized solution to simplify your supply chain and accelerate your discovery through clinical development. You’ll be able to develop small molecules 8–12 weeks faster than the industry-standard 15 months, and large molecules 14–20 weeks faster. And the advantages don’t end there…
What’s the best path for your low soluble molecule? Two molecules, both designed to treat the same condition, both with solubility challenges. Two biopharma companies racing to be first. Biopharma A chooses to move into trials as quickly as possible, while Biopharma B decides to address broader solubility concerns first. Who gets to market first may surprise you.
Oral Solids. Access a remarkable range of conventional and specialized oral solid dosage form capabilities and scale. Further expand your options with innovative combinations of these forms and a variety of controlled-release technologies.
Phase I clinical materials in as little as 12 weeks. Only twelve weeks from receipt of your API, Patheon Quick to Clinic™ can deliver bulk clinical trial materials for first-in-human studies. That includes a one-month stability study so you have all the data you need to make informed proof of concept decisions and complete regulatory submissions. What’s more, this accelerated program gives you the choice of five dosage forms. In the pharmaceuticals industry, speed is important but consistent high quality is a must. Your project will be carefully monitored by our global quality management system. This will ensure that each and every dose is equally compliant, safe and effective.