Nicholas W. Warne - Articles and news items

Peracetic acid in the study of rhIL-11 methionine oxidation

Issue 3 2008, Past issues / 19 June 2008 /

Recombinant human interleukin-eleven (rhIL-11) is a pleiotropic cytokine which stimulates stem cell proliferation and affects multiple cell types1. The protein has been demonstrated to provide clinical benefit in platelet restoration2 and Crohn’s disease3. rhIL-11 is a highly basic protein that is rich in arginine, leucine and proline residues, lacks disulfide bonds, is not glycosylated and is not homologous with other known hematopoietic growth factors4. In the development of stable dosage forms of rhIL-11, we have examined the protein’s stability toward methionine oxidation.

Lyophilization: cycle robustness and process tolerances, transfer and scale up

Issue 3 2008, Past issues / 19 June 2008 /

During the past 10-15 years, close attention has been paid to the development of optimal lyophilization cycles for different types of pharmaceuticals1-4. Recent advances in process control, such as the Smart Freeze-DryerTM technology or similar approaches,5-7 make cycle development a routine procedure. The attention of many researchers has shifted to the aspects of cycle transfer and scale up that still require significant investment in understanding the differences in lyophilization processes between laboratory and commercial dryers8-14. Conducting numerous experiments in an attempt to demonstrate that a laboratory cycle is not only optimal but also robust, requires significant material and time investment. Mathematical modelling of lyophilization processes proved to be a very useful tool, not only for cycle development15-19 but also for cycle transfer and scale up11,14. The same mathematical approach (as discussed in experiment14) was applied to the process tolerances design and estimation of cycle robustness in regard to the product temperature.


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