RT Journal Article
SR Electronic
T1 Sensor-Based System for Rapid and Sensitive Measurement of Contaminating DNA and Other Anaiytes in Biopharmaceutical Development and Manufacturing
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 7
OP 12
VO 45
IS 1
A1 Briggs, Jonathan
YR 1991
UL http://journal.pda.org/content/45/1/7.abstract
AB The Threshold System provides for rapid and highly sensitive measurements of a variety of anaiytes at low concentration. The operating principles of the measurement system, including signal detection utilizing a proprietary silicon sensor, are described. The first application to run on the Threshold System is a quantitative assay for picogram levels of total DNA. This assay is of great value for monitoring levels of contaminating DNA in purified and in-process biopharmaceuticals. After sample pretreatment, the total assay time is less than two hours. The assay performance characteristics are described, along with data demonstrating sensitivity, precision, and accuracy. Pretreatment procedures for biopharmaceutical proteins are discussed. Two additional applications on Threshold are introduced. First, a universal ligand-binding assay system provides quantitative measurement of antigens or antibodies, in a variety of biological media, with speed, sensitivity, and precision. Second, preliminary results of rapid DNA-probe measurements on Threshold are presented.