ABSTRACT
The United States Pharmacopeia (USP) develops public standards for medical products that are enforceable by FDA. USP general information chapters have been providing industrial and academic researchers alike with crucial guidance especially in areas where there is absence of regulatory guidance. In an effort to meet the challenge of rapid advances in vaccine research and manufacturing, the Council of Experts Committee for Vaccines, Virology, and Immunology of the US Pharmacopeia has recently initiated two new general chapters to provide advice for researchers and manufacturers in the vaccine and virology fields and beyond. Chapter 1235 Vaccines and Vaccine Test Methods will focus on manufacturing and analytical requirements for the different types of vaccines currently in manufacture and development. Chapter 1237 Virology Test Methods will discuss modern diagnostic virology techniques and a variety of tests as applicable to vaccine and biologics manufacturing.
Subject(s)
Allergy and Immunology , Pharmacopoeias as Topic , Vaccines , Virology , Allergy and Immunology/standards , Biological Products , Biotechnology , Humans , United States , Vaccines/standards , Virology/standardsABSTRACT
B lymphocyte stimulator (BLyS), a member of the tumor necrosis factor (TNF) superfamily, is a cytokine that induces B-cell proliferation and immunoglobulin secretion. We have determined the three-dimensional structure of BLyS to 2.0 A resolution and identified receptor recognition segments using limited proteolysis coupled with mass spectrometry. Similar to other structurally determined TNF-like ligands, the BLyS monomer is a beta-sandwich and oligomerizes to form a homotrimer. The receptor-binding region in BLyS is a deeper, more pronounced groove than in other cytokines. The conserved elements on the 'floor' of this groove allow for cytokine recognition of several structurally related receptors, whereas variations on the 'walls' and outer rims of the groove confer receptor specificity.
