Millipore Technical Publications |
 | Data Sheet - SDS1708ENEU | |
MicroSafe Services - Nucleic Acid Techniques – Mollicute Screening Assay | ||
| Lit Number: | SDS1708ENEU | |
| Year: | 2006 | |
The analytical method of Nucleic Acid Techniques (NAT) is utilized in a variety of both cell and gene product applications for in-process testing during drug product manufacturing and as a rapid supplement to compendial release testing methods.1
MicroSafe Services from Millipore provides a validated method for NAT using qualitative real-time polymerase chain reaction (QPCR) for the rapid detection of mollicutes, of which mycoplasma is a member.2 This rapid and accurate molecular based method for in-process testing is being driven by Process Analytical Technology (PAT), which calls for the manufacturer to audit its production line in real time at multiple points.3 The benefits of this initiative and method enable the manufacturer to make any necessary decisions and adjustments earlier in its process based on rapid test results, reducing the risk of contamination at the final product testing stage—which is extremely costly and ultimately delays the release of drug product.
1 USP reference: General Chapters: <1046> Cell And Gene Therapy Products — Analytical Methodologies
2 EP 2.6.21 “Nucleic Acid Amplification Techniques”
3 Process Analytical Technology Guidance (PAT): A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (09/04).