Formulation Development

FORMULATION DEVELOPMENT – Next-Generation PEGylation Enables Reduced Immunoreactivity of PEG-Protein Conjugates

Merry R. Sherman, PhD; Mark G.P. Saifer, PhD; L. David Williams, PhD; Shawnya J. Michaels, MS; and Monika A. Sobczyk, MS; illustrate the close parallels between the results of Armstrong et al with respect to anti-PEG antibodies detected in sera of ALL patients treated with mPEG-asparaginase and the results reported by Sundy et al based on the Phase III clinical trials of mPEG-uricase in patients with RCG



HIGH PURITY EXCIPIENTS – A Simple Solution to a Complex Problem

William Small, PhD, and Arsalan Khan say drug degradation can have toxicological effects in many instances, and it is imperative that this mechanism be minimized as much as possible. The best solution to this is to ensure that appropriate ingredients, both high in quality and purity, are chosen and used throughout the entire drug product lifecycle.