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Thermo Fisher Scientific
Early-phase injectable formulation development: Proven strategies for success
White paper
Authors:
Alessandro Chreim, Christy Eatmon, and Liji Joseph
Developing formulations for injectable therapeutics can be met with unexpected challenges. Many molecules, both large and small, have poor solubility, especially at the high concentrations used for injectables. They may also have high viscosity, which is undesirable. Additionally, many molecules are sensitive to light, heat, oxidation, and other exposures.
This white paper summarizes a discussion with three subject matter experts from Thermo Fisher Scientific, Alessandro Chreim, Christy Eatmon, and Liji Joseph, on their approach and best practices for formulation development. This paper explores tools like DOE modeling, analytical characterization, and risk-based approaches. It covers:
- General approaches to formulation development: Strategies and methodologies for developing effective injectable formulations.
- Addressing core challenges in formulation development: Tackling issues such as poor solubility, high viscosity, and sensitivity to environmental factors.
- Complex, late-stage formulation development including the development of higher concentrations: Advanced techniques for developing formulations at higher concentrations.
- Bridging the gap from formulation to GMP: Ensuring a smooth transition from formulation development to Good Manufacturing Practice (GMP) compliance.
Download the white paper to learn the proven strategies for successful injectable formulation development.
