VI.D.12. Hepatitis B (Protocol 1516.040 M.A., Inc.): 
This procedure is designed to detect small amounts of Hepatitis B surface 
antigen that may be present in the test article which would be detected by a third 
generation ELISA assay. 
VI.D.13. Porcine Parvovirus (Protocol 1514.033004 MA, Inc.): 
This assay is designed to detect Porcine Parvovirus (PPV) in cell cultures. 
Test and control articles are analyzed by inoculation of indicator cell cultures and 
examined for at least 14 days for the presence of CPE. Cultures are also tested for 
the presence of specific viral antigens using fluorescent antibody techniques. 
VI.D.14. Adeno-Associated Virus Hybridization (Protocol 1516.104016 
MA, Inc.): 
This assay detects adeno-associated virus DNA present in the test article as 
determined by Southern hybridization using a 32 P labeled DNA probe. 
VI.D.15. Parvovirus B-19 Hybridization (Protocol 1516.104017 M.A., 
Inc.): 
This protocol is designed to detect parvovirus B-19 DNA that may be present 
using Southern hybridization with a 32 P labeled DNA probe. 
VI.D.16. Replication Competent-Adenovirus Assay (Protocol 1514.031002 
MA, Inc.): 
This assay is designed to detect the presence of human adenovirus in the test 
article. Indicator cell cultures are inoculated and observed periodically for CPE, a 
passage is performed for enhancement. 
VI.E. Characterization of adenovirus seed Lot 
Each seed lot will be prepared, cryopreserved and aliquots evaluated 
according to the following criteria: 
Mycoplasma (M.A., Inc.)-see above 
Sterility (M.A., Inc.)-see above 
In vitro virus (M.A., Inc.)-see above 
Adeno-associated virus (M.A., Inc.)-see above 
Parvovirus B-19 hybridization (M.A., Inc.)-see above 
Electron microscopy (M.A., Inc.)-see above 
Replication competent Ad5-please see description of assays in section 
VI. H. 
Recombinant DNA Research, Volume 17 
