RT Journal Article
SR Electronic
T1 Evaluation of ATP-Bioluminescence Detection as a Supportive Technology for Bioburden and Sterility Testing Processes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 759
OP 760
DO 10.5731/pdajpst.2024.99905
VO 78
IS 6
A1 Arias, Madaisabel
A1 Osuna-Najarro, Ashley
A1 Lute, Scott
A1 Candau-Chaucon, Reyes
A1 Pfeiler, Erika
A1 Johnson, Sarah
A1 Faison, Talia
YR 2024
UL http://journal.pda.org/content/78/6/759.abstract
AB A challenge facing the biomanufacturing industry is the lengthy timeline for quality control testing that delays critical go/no-go decision making for the rapid release of drug products. The recommended USP methods for bioburden and sterility testing are surface-spread plating method and direct inoculation method, respectively. These compendial methods are reliable; however, results take approximately 5-7 days for bioburden testing (USP< 61>) and no less than 14 days for sterility testing (USP < 71>). ATP-bioluminescence detection is a rapid microbial method (RMM) that can reduce the time to result for both bioburden and sterility testing, taking 18-24 hours and 6 days, respectively. This study aims to evaluate the performance of ATP-bioluminescence in comparison to compendial methods to understand the implications of using this technology in bioburden and sterility testing processes. The research conducted consisted of simulating contamination to assess the detection capabilities of the ATP-bioluminescence assay. Results from compendia and ATP-bioluminescence detection were analyzed for comparability. Findings from this study will provide insight on the use of this platform as an alternative tool for in-process testing.