Considerable resources are spent within the biopharmaceutical industry to perform viral clearance studies, which are conducted for widely used unit operations that are known to have robust and effective retrovirus clearance capability. The collaborative analysis from the members of the BioPhorum Development Group Viral Clearance Working Team considers two common virus reduction steps in biopharmaceutical processes: low-pH viral inactivation and viral filtration. Analysis included eight parameters for viral inactivation and nine for viral filtration. The extensive data set presented in this paper provides the industry with a reference point for establishing robust processes in addition to other protocols available in the literature (e.g., ASTM Std. E2888-12 for low-pH inactivation). In addition, it identifies points of weakness in the existing data set and instructs the design and interpretation of future studies. Included is an abundance of data that would have been difficult to generate individually but collectively will help support modular viral clearance claims.

season) (64%), 1990-91 (601%), and 1991-92 (62%). During 1989-90 subgroup A represented the majority of isolates (80N%). Subgroup B predominated during only one season, 1988-89 (94%). No microheterogeneity within subgroups was apparent as judged by the monoclonal antibody reactivity pattern. More male than female children were affected overall, but no sex-related difference between subgroup infections could be detected (P = 0.28). The majority of patients were less than 1 year of age, and no significant association between age and subgroup was detected after stratifying for year (P = 0.64). This is, to our knowledge, the first comprehensive longitudinal RSV subgroup prevalence study from the Pacific Northwest and from Canada.

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Using a panel of eight monoclonal antibodies directed against the G, F and NP proteins of respiratory syncytial virus, 167 virus isolates from nasopharyngeal washing cultures at British Columbia Children's Hospital during two consecutive epidemics were subgrouped. Slides made and frozen at the time of virus isolation or prepared from recovered frozen passage material, were assayed by indirect immunofluorescence. Of 85 strains tested in 1987-88, 54 (64%) were subgroup A, and 31 (36%) subgroup B. By contrast, of 82 strains tested in 1988-89 five (6%) were subgroup A and 77 (94%) subgroup B. Review of patient charts did not reveal significant differences in clinical course of patients infected with the two subgroups, but the risk of infection with subgroup A was significantly greater than the risk of subgroup B infection in younger patients.

The occurrence of antigenic variation among nine isolates of bovine respiratory syncytial virus (BRSV) was determined by examining their reaction patterns to human respiratory syncytial virus (HRSV) subgroup A and B monoclonal antibodies (MAbs) by enzyme immunoassay and radioimmunoprecipitation with fractionation by sodium dodecyl sulfate-polyacrylamide gel electrophoresis by using MAbs and polyclonal antisera to HRSV and BRSV. Shared epitopes were demonstrated on four of five structural proteins between BRSV and both subgroups A and B of HRSV. The nine isolates of BRSV showed different patterns of reactivity in enzyme immunoassays with panels of MAbs to HRSV subgroups A and B. Major variations in the molecular weights of the P (phosphoprotein) and F (fusion protein) proteins were demonstrated among the BRSV isolates tested. These results suggest that BRSV belongs to a different antigenic grouping than HRSV and that BRSV is composed of two distinct subgroups.