Small molecule solutions

Advancing your small molecule with speed and agility

Small molecule projects come with distinct demands, including solving solubility and biovailablility challenges, addressing a complex regulatory environment, and ensuring a consistent supply of raw materials of the highest quality. Regardless of project size and scope, success requires a partner with a range of flexible drug substance, drug product, and clinical trials supply solutions to cover all milestones—on time, on budget, and with supply chain and business continuity.

Our small molecule development and manufacturing services are fully integrated into one continuous project plan designed to simplify hand-offs, reduce errors, avoid rework and costly delays, and shorten timelines to speed your treatments to patients. We offer everything you need to reduce your reliance on multiple vendors and gain efficiency.

  • Integrated global network of more than 60 sites across 23 countries

  • Trusted team of experts with proven expertise to help along your journey to market

  • Patheon Quadrant 2TM predictive modeling platform to solve solubility and bioavailability challenges 

 

 

 

Collaboration from clinic to commercialization

Unlocking speed, quality, and efficiency

You have many questions about your small molecule. How should you synthesize it? How can you develop it for study? What’s the best formulation? How can I scale up my project? What’s the impact on the supply chain? What’s the right level of data to file my IND with speed? What issues might arise? We help you get small molecule development right the first time, with a combination of end-to-end solutions, deep expertise, and industry-leading technology. 

 

Extensive planning and execution to take out the guesswork 

  • Assess potential roadblocks for your idea or molecule 
  • Plan an effective development program
  • Determine the right formulation
  • Manufacture and distribute drug substance for clinic 
  • Develop a packaging and distribution approach 
  • Conduct clinical research
  • Guide regulatory approval
  • Manufacture and distribute drug product  

Why are small molecules more challenging to manufacture than large molecules?

Large molecules are generally injected, readily delivering them into the patient’s system. Small molecules, however, have a greater challenge—making it through the gastrointestinal system and liver, which act as defensive barriers against potentially harmful synthetic molecules. Small molecules must also dissolve to be absorbed, and the rates of absorption may need to be tailored. Finally, the solid-state properties of small molecules require manufacturing into consistent and safe unit doses for patients. 

Active pharmaceutical ingredients (API)

Benefit from seamlessly aligning API and drug product development and manufacturing.

  • Early development solutions

  • Process development, validation scale-up, and tech transfers

  • Second generation process development

  • Analytical services

  • Solubility solutions 

Oral solid dose (OSD)

Leverage our flexible oral solid dose (OSD) commercial manufacturing solutions for business and supply chain continuity.

  • Formulation development

  • Process development and optimization

  • Dosage forms

  • Tech transfers 

Softgels

Engage us for prescription and over-the-counter softgel formulations—for early development through commercial manufacture.

  • Enhanced bioavailability
  • DEA-controlled substances
  • Abuse-deterrent products 
Steriles

Solve complex challenges throughout your product lifecycle  

  • Formulation development
  • Process development, validation, and scale up solutions 
  • Drug delivery and fill/finish services
  • Cold chain services