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 solution to address bioavailability challenges that exist with approximately 80% of products in clinical development. Thermo Fisher provides capabilities and expertise in spray drying thermodynamics that can be leveraged from early development to commercial scale. Having the experience of spray drying over 120 molecules we are well positioned to integrate API, solid state chemistry, spray drying and product development and scale up to serve all your development needs.

Our global sites utilize a range of spray drying technology suited to process development, scale-up and commercialization, 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:

Predictive in-silico modelling – ‘Engineered Solutions’

Download our Solid & Sterile Dose Form Brochure.

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