How we enable success in OSD early development to ensure commercial success.

Avoid rework and costly delays by getting formulation right from the start

Getting formulation right from the start of early development can help save time and money as you advance through each phase and on to commercialization. Our early development formulation experts and scientists are here to support every step of your project. Gain access to an integrated drug formulation program for flexible and tailored solutions to:

Solve solubility and bioavailability challenges before they become long term issues

Poorly soluble compounds often demonstrate lower bioavailability, which can reduce the efficacy of the drug substance or product. Approximately 80 percent of molecules experience bioavailability challenges, so being proactive about this early on can save you both time and money.

Leveraging our Quadrant 2™ program helps in early formulation development by in-silico predictions of formulations. This in-silico formulation development approach saves time and cost by avoiding empirical, more traditional trial-and-error approaches. The Quadrant 2™ model analyzes 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:

We have analyzed 250+ molecules using Quadrant 2™ for bioavailability challenges.

Spray Drying provides a strategic solution to address bioavailability or crystallization challenges that are common across many drug substances and drug products. Thermo Fisher provides spray drying strategies that can be leveraged from early development to the commercial scale. We have extensive expertise and experience in spray drying thermodynamics, having spray dried over 120 molecules. Our various global sites utilize a vast array of spray drying technology, including:

Hot melt extrusion (HME) is a strategy to manufacture amorphous solid dispersions (ASDs). Leveraging Thermo Fisher’s HME solutions results in solvent-free processing, reduced cost of goods (COGs), and continuous manufacturing.

Additional technologies to solve bioavailability and solubility challenges include:

Download our Solid & Sterile Dose Form Brochure.