The Rapid Micro Blog

Our blog will keep you informed of new and noteworthy technologies, reviews of recent publications and presentations, upcoming conferences and training events, and what's changing in the rapid and alternative microbiological methods world.

Viral Safety and Mycoplasma Testing

Emiliano Toso, Merck-Serono, provided an overview of recent viral contamination events within the industry (e.g., 2009 Vesivirus contamination at Genzyme, resulting in >$300MM in lost sales), and the advantages of using nucleic amplification and PCR-based techniques to rapidly detect the presence of viruses. He explained that the diversity of viruses makes viral detection and their selective destruction difficult. However, the use of rapid viral methods (he calls these RVMs) could provide fast in-process control, thereby reducing the risk of large-scale contamination events with bioprocessing facilities. An example work flow for in-process monitoring of viral contamination includes clarification or concentration of unprocessed bulk harvest material, followed by DNA/RNA isolation and then reverse transcriptase PCR. Using this strategy reduces a 3-month in-vivo viral detection assay down to a 1-2 day qPCR in vitro assay.

Next, Miguel Nogueras, Abbott, discussed the use of rapid methods for Mycoplasma detection. He described the current 28-day assay and how faster testing is required for products with short half-lives (e.g., autologous and tissue based products), raw materials, release testing, process development testing, cell line or virus sock qualification and contamination monitoring. A variety of RMM techniques were described, including nucleic acid amplification, immunological tests, enzyme based methods, and hybridization methods without the need for nucleic acid amplification. He then described Abbott’s strategy for validating a RMM using the following parameters: interference, specificity, detection limit, precision, reproducibility, robustness, system suitability and comparability. The latter established a relationship between the RMM and existing method unit of measurement (e.g., genomic copies, protein or enzyme vs. CFU). Finally, Miguel discussed their strategy for validation and implementation, which included design planning, input, output, verification, validation and transfer. During these phases they were actively engaging the regulatory authorities.

Post a Comment

Previous Post Next Post

Contact Form