+1 (800) 638-8174
+1 (800) 521-0390
+ 32 87 321 611
+ 32 87 321 611
Contact your local Lonza Distributor
Tel: +1 (800) 638-8174
Fax: +1 301 845 8291
Traditional culture methods have been the gold standard for routine pharmaceutical and biological quality control testing for nearly a century. However, these methods have not kept pace with industry challenges to reduce time-to-results for in-process, intermediate, and final release testing.
Designed to meet the critical needs of today’s quality control (QC) laboratory, Lonza’s QC Testing and Analytical Services offer rapid microbiology products that are reliable, easy-to-use, and provide same-day microbiology results for many quality control applications.
Faster microbial testing could have major benefits, such as higher throughput, more reliable and reproducible processing of samples, improved traceability, and overall, better control over manufacturing processes, allowing for earlier product release. Obtaining faster results enables more practical in-process testing and real time testing of products with short shelf lives, and can also facilitate Out of Specification (OOS) investigations, eliminating bottlenecks in the manufacturing process encountered with retrospective detection methods.
Same day results offer customers the ability to make proactive decisions and take corrective actions sooner, offering unique insight to QC environments.
MycoTOOL® PCR Mycoplasma Detection Kits and Testing Services
Mycoplasma contamination in biopharmaceutical production, cell therapy, and tissue engineering products can be a serious problem for development from the R&D phase through the production phase. Mycoplasma can induce changes in cell metabolism and growth, while severe infections may even destroy a cell line, ultimately impacting product quality. Traditional culture-based mycoplasma detection methods are time-consuming, requiring as much as 28 days to complete. Therefore, early detection of mycoplasma contamination during product manufacturing is critical.
Rapid mycoplasma detection kits and testing services using the MycoTOOL® PCR Mycoplasma Detection Kit from Roche are now available through Lonza. Approved by the European Medicines Agency (EMA), the MycoTOOL® PCR test is the first commercially available assay to replace traditional, time-consuming mycoplasma culture tests for release testing of several pharmaceutical products.
For use in quality control/manufacturing process only.
MYCOTOOL is a trademark of Roche.