Characterizing Biological Products and Assessing Comparability Following Manufaturing Changes  

Oleh:

Chirino, Arthur J. ; Mire-Sluis, Anthony

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Nature Biotechnology: The Science and Business of Biotechnology vol. 22 no. 11 (Nov. 2004), page 1383-1392.
Topik: MANUFACTURING; biological products; comparability; manufacturing changes

Ketersediaan

Perpustakaan Pusat (Semanggi) Nomor Panggil: NN9.3 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Changes in production methods of biological product may necessitate an assessment of comparability to ensure that these manufacturing changes have not affected the safety, identity, purity or efficacy of the product. Depending on the nature of the protein or the change, this assessment consists of a hierarchy of sequential tests in analytical testing, preclinical animal studies and clinical studies. Differences in analytical test results between pre and post change products may require functional testing to establish the biological or clinical significance of the observed differences. An underlying principle of comparability is that under certain conditions, protein products may be considered comparable on the bases of analytical testing results alone. However the ability to compare biological materials is solely dependent on the tests used, since no single analytical method is able to compare every aspect of protein structure or function. The advantages and disadvantages of any given method depends on the protein property being characterized.

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