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Published on: August 17, 2011
A high throughput protein formulation platform: case study of salmon calcitonin
Martinus A H Capelle1, Robert Gurny, Tudor Arvinte
1Department of Pharmaceutics and Biopharmaceutics, School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Quai E-Ansermet 30, 1211, Geneva 4, Switzerland.
Pharmaceutical Research
|July 5, 2008
Summary
High throughput spectroscopy effectively identified stable salmon calcitonin formulations. This method rapidly characterizes protein stability, confirming its potential for pharmaceutical development.
Area of Science:
- Biophysical Chemistry
- Pharmaceutical Sciences
- Protein Formulation
Background:
- Developing stable protein formulations is critical for drug efficacy.
- High throughput screening methods are needed to accelerate formulation development.
Purpose of the Study:
- To assess the feasibility of high throughput spectroscopy for characterizing and selecting stable protein formulations.
- To investigate the stability of salmon calcitonin (sCT) in various aqueous formulations.
Main Methods:
- Prepared 100 aqueous sCT formulations using 20 buffer compositions (pH 2.5-10.5).
- Analyzed sCT stability over 7 days using protein concentration, turbidity, and intrinsic/dye fluorescence assays (ANS, Nile Red).
- Utilized fluorescence dyes to monitor protein conformational changes.
Main Results:
- 27 out of 100 sCT formulations remained stable after 1 day.
- 12 stable sCT formulations were identified after 7 days.
- Optimal stability was observed in 10 mM sodium acetate buffer at pH 3.5-5.5.
Conclusions:
- Spectroscopic methods successfully identified stable sCT formulations.
- The results align with commercially available sCT formulations.
- This study demonstrates a proof of concept for a high throughput protein formulation platform.
