Formulation & Drug Development

Partner with Patheon, by Thermo Fisher Scientific, to take your discoveries to the proof-of-concept milestone with speed and efficiency while laying a firm foundation for commercial success. Our formulation experts have helped clients receive more NDA approvals than any other CMO – with 117 NDAs in 2008-2017.* By offering the full range of analytical, formulation and dosage form technologies and solutions, we can tailor a lean, fully integrated drug formulation program precisely suited to your molecule and business. This will accelerate your project to first-in-human studies and beyond.  

Fully integrated services for speed, flexibility and efficiency

Our drug development experts give you access to a full breadth of advanced scientific and preformulation services to meet all your early development needs, enabling you to:

  • Rapidly characterize your drug substance
  • Quickly evaluate formulation options
  • Overcome formulation challenges such as low bioavailability
  • Gain a clear view of your path through preclinical and clinical studies
  • Develop and manufacture fit-for-purpose early-phase clinical materials
  • Design, validate and implement analytical and process methodologies
  • Generate the data required for IND filings

At every step, our early development experts will guide you with advice founded in our experience of thousands of projects – we can offer you one partner, one team, and one seamless process. We offer the most rapid and cost-effective way to achieve early clinical success. With us, you’ll be well positioned with maximum investment value and a firm scientific foundation for the work ahead.  

Solving bioavailability issues before they become problems

Over 80 percent of molecules experience bioavailability challenges. If not resolved early, these issues can derail early phase trials, and also lead to higher costs and missed deadlines in later stages. Patheon’s Solubility Enhancement Services approaches BCS II and IV drug substance solubility issues in a fundamentally different way – one that identifies the bioavailability enhancement technologies most likely to work before you get started. That helps eliminate rework and worry later on. We offer broad technological capabilities, including:

 

Taking the time and guesswork out of formulation

Our one-of-kind, computational modeling tool, Quadrant 2®, is designed exclusively for Thermo Fisher Scientific clients. This innovative program rapidly accelerates early formulation development and prevents the costs of trial and error experimentation. Quadrant 2® analyses the molecular structure, physical and chemical characteristics of a compound, and predicts the solubility enhancement technology and excipient combination that are most likely to succeed based on:

  • API chemical structure
  • Physicochemical properties
  • Full-scale molecular modelling
  • Exclusive excipient descriptor database developed by Patheon, by Thermo Fisher Scientific

Quadrant 2® has been confirmed via a cross verification/model validation approach with more than 70 commercially available molecules, and proven to be over 90 percent accurate for technology selection and over 80 percent accurate for excipient selection. With Patheon’s Solubility Enhancement Services, you’ll have a partner you can trust with the skills your discovery deserves, including:

  • Comprehensive analytical services
  • Preformulation characterization and technology screening
  • Formulation design and process development built upon computer modeling and Quality by Design principles
  • Proven cGMP clinical-scale manufacturing
  • An array of solubility technologies that includes proven solutions not available anywhere else

 

Quick-to-Clinic™ accelerates the time to Phase I clinical trials

In as few as 14 weeks from API delivery, the Quick-to-Clinic™ program delivers high quality Phase I material and the data you need to support your Phase I clinical trials. This one-of-a-kind program delivers:

  • Phase-appropriate analytical method development and validation
  • Phase-appropriate simplest of dosage forms (API in a capsule, tablet or bottle)
  • Bulk packaging or simple in-house HDPE bottles
  • One-month stability testing
  • Clinical packaging and labelling and release
  • A product development summary report

 

Late stage development: a crucial pivot point

The late stages of pharmaceutical development are a crucial pivot point. Work with us to fully capitalize  on early-stage success with our deep knowledge of what’s required in the stages to follow. Benefit from robust processes, scalability, manufacturability, reliability and high quality. With Thermo Fisher Scientific, you’ll have access to a fully integrated network of facilities with equipment aligned for seamless scale-up, as well as expertise and capabilities that will propel your product through approval to commercialization. We can work with you to optimize your formulation and processes, offering extensive technical expertise, a large array of oral solid, sterile and softgel finished dosage forms and unique solutions only available thanks to our drug development expertise. In Thermo Fisher Scientific, you’ll have a partner dedicated to solving your toughest challenges, helping you develop your discovery to its full potential, and accelerate timelines to get your product to waiting patients faster. This approach has driven our development and manufacture of nearly 27 percent of the world’s top 100 Rx drugs. And it’s the approach that will drive the development of your drug. *Source: PharmSource ® Trend Report, March, 2016.