Two validated methods for nucleic acid techniques (NAT) for biopharmaceutical product testing are now available from MicroSafe Services from Millipore based in the Netherlands
The screening assay uses qualitative real-time polymerase chain reaction (QPCR) for the rapid screening of mollicutes and the bacterial identification assay is performed using sequencing analysis.
The ability to detect the presence of contamination earlier in the drug manufacturing process as well as identify the specific bacterial species, enables key decisions to be made at various points in the drug manufacturing process, mitigating risk and improving quality assurance.
Mollicute screening.
The validated, rapid screening of mollicutes, of which mycoplasma is a member, enables manufacturers to test at any point and make any necessary adjustments to their manufacturing process.
Dependent on the product to be tested, this assay can be adapted and validated to customers' specific processes.
The rapid detection of mollicutes is performed using universal primers and SYBR Green I as the fluorescent dye in the QPCR.
The specificity of the primers is directed but not limited to Acholeplasma laidlawii, Mycoplasma arginini, M fermentans, M gallisepticum, M hyorhinis, M orale, and M synoviae, with a limit of detection of 1cfu/ml.
Bacterial identification.
Also now available from MicroSafe Services from Millipore is a validated NAT method for accurate bacterial identification based on recent advances in rapid, molecular-based sequencing technologies.
This method is applicable to all areas of biopharmaceutical processing when identification is necessary to assist with faster product release and implementation of corrective actions.
"The basis of microbial taxonomy has changed from its previous phenotypic base to a genotypic base.
"Genotypic typing is based on the sequencing of the highly conserved 16SRNA gene.
"The major consequence of this change is the perception that phenotypic identification methods have lost accuracy and precision.
"This perception causes significant problems for decisions concerning product disposition and complicates root cause analysis.
"The usage of NAT for genotypic typing is a powerful tool for determining root cause analysis.
"Additionally, its speed compared to classical identification techniques also fits at least philosophically with the FDA's PAT initiative and assists with timely CAPA actions," stated Mike Edgington, CEO of Edgington Associates.
These new tests methods from MicroSafe Services from Millipore support the PAT (Process Analytical Technology) initiative, which calls for manufacturers to audit their production line at multiple points.
Obtaining results at various points helps pinpoint when contamination occurred as well as identify the bacteria present, allowing a manufacturer to take the necessary steps to correct their process.
