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Peracetic acid in the study of rhIL-11 methionine oxidation

19 June 2008 | By

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…

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

19 June 2008 | By Serguei Tchessalov and Nicholas Warne, Wyeth BioPharma, Andover

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…