Small molecule drug development and manufacturing services
Advancing your small molecule with speed and agility
Small molecule drugs are chemical compounds that have a low molecular weight, typically below 900 daltons. Due to their small size and chemical characteristics, small molecule drugs are well-suited to enter the gastrointestinal tract and quickly absorb into the bloodstream. Additionally, they can easily pass through cell membranes to exert their therapeutic effects. Today it’s estimated that small molecules account for 90% of drugs in the market. One reason they’re so popular and patient-friendly is that they can be taken orally, which makes them convenient for all ages.
That said, small molecule drug development and manufacturing has changed substantially in recent years. Thanks to the rise of molecularly targeted therapies to treat conditions like cancer, the development of small molecule active pharmaceutical ingredients (APIs) and corresponding drug products is more complex than ever — requiring increasingly specialized API manufacturing processes and drug delivery solutions.
For biotechnology and pharmaceutical companies looking to outsource key aspects of small molecule drug development and manufacturing, they should turn to a high-quality CDMO that has the depth and breadth of industry experience in successfully navigating small molecule API development and manufacturing from beginning to end. .
At Thermo Fisher Scientific, our CDMO capabilities for small molecules span the gamut, including specific solutions for APIs, oral solid doses, steriles, and softgels. We leverage our industry-leading experience and expansive track record to help guide your project while simultaneously simplifying hand-offs, reducing errors, avoiding rework, reducing costs, and shortening timelines — ultimately helping patients in need.
Explore our small molecule CDMO solutions for APIs, oral solid doses, softgels, and steriles, or contact a Thermo Fisher Scientific representative to learn more.
Collaboration from development 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
- API development and API manufacturing
- Route scouting and solid-state chemistry to ensure fit to desired phase-appropriate formulation
- Phase-appropriate formulation development
- Bioavailability enhancement and digital modeling
- Particle engineering
- Broad range of dosage forms and release profiles
- Clinical trial services
- Regulatory approval services
Why it's important to tackle bioavailability challenges early on
The poor bioavailability of many active pharmaceutical ingredients (APIs) due to low solubility is a major challenge in the pharmaceutical industry; indeed, it's estimated that approximately 70% of new drug canidates have poor solubility. That's why it's essential to identify and address bioavailability challenges early in the drug development and manufacturing journey. By doing so, you can help create a more robust product profile and increase the liklihood of success as your small molecule moves to the clinic. Check out our comprehensive range of services that can help improve the solubility of your small molecule.
Small molecule CDMO solutions and capabilities
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
Spray drying services
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
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
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