by Elisabeth Lehmberg, PhD, Paul Shabram, Thomas Schluep, ScD, Shu Fen Wen, PhD, Barry Sugarman, PhD, Maria Croyle, Michael Koehl, Edwige Bonfils, PhD, Daniel Malarme, Geoffrey Sharpe, PhD, Heike Nesbit, PhD, Flavia Borellini, PhD, Amine Kamen, PhD, Beth Hutchins, PhD, and Gary Vellekamp, PhD
Volume 2, Issue 3 (May/June 2003)
With the continued progress of adenoviral vectors in gene therapy studies it is increasingly evident that a more formalized approach to the characterization and analysis of these viral vectors is urgently needed. Today, adenoviral vectors are beginning to be considered “well characterized biologics,” as shown by numerous publications describing sophisticated analytical approaches for recombinant adenovirus product candidates. Because the analytical definitions of adenoviral vectors currently lack comparison to a common standard, the problem for regulatory agencies is how to objectively evaluate safety in relation to the administered dose. This well-recognized need for an adenovirus standard has been addressed by a consortium of representatives from regulatory agencies, industry, and academic organizations — the Adenoviral Reference Material (ARM) Working Group. Its work has come to fruition in the recent public availability of the ARM, a purified wild type 5 adenovirus. Many aspects of the history, production, and characterization of the ARM have been published in detail…
Citation:
Lehmberg E, Shabram P, Schluep T, Wen SF, Sugarman B, Croyle M, Koehl M, Bonfils E, Malarme D, Sharpe G, Nesbit H, Borellini F, Kamen A, Hutchins B, Vellekamp G. Adenovirus Reference Material: Determination of Particle Concentrations Obtained by Orthogonal, Physical-Chemical Methods. BioProcess J, 2003; 2(3): 50-55.