4.4. General issues
Once hits are identified by deep sequencing, it will be important to confirm the presence of the contaminant by a second molecular method. Infectivity should be assessed if an appropriate assay exists. The presence of certain viral nucleic acid, e.g. that remaining after viral inactivation or reduction processes, may be considered acceptable if there is no evidence of infectious virus, though the fact that some viruses produce infectious (S)-10-Hydroxycamptothecin [29], [30] and [31] necessitates a cautious approach. Investigation procedures both within a Good Manufacturing Practice and regulatory![image]()
setting will likely follow existing guidelines.
4.4.1. Intended use and limitations of the reference material
The reagent is primary root intended to be used as a control to assess assay performance relative to the results presented herein, or to results from historical runs of the reagent. While not a proficiency testing material (since some assays have different design parameters), the reagent will enable users to perform inter-assay, intra-laboratory and inter-laboratory comparisons.
Once hits are identified by deep sequencing, it will be important to confirm the presence of the contaminant by a second molecular method. Infectivity should be assessed if an appropriate assay exists. The presence of certain viral nucleic acid, e.g. that remaining after viral inactivation or reduction processes, may be considered acceptable if there is no evidence of infectious virus, though the fact that some viruses produce infectious (S)-10-Hydroxycamptothecin [29], [30] and [31] necessitates a cautious approach. Investigation procedures both within a Good Manufacturing Practice and regulatory
setting will likely follow existing guidelines.4.4.1. Intended use and limitations of the reference material
The reagent is primary root intended to be used as a control to assess assay performance relative to the results presented herein, or to results from historical runs of the reagent. While not a proficiency testing material (since some assays have different design parameters), the reagent will enable users to perform inter-assay, intra-laboratory and inter-laboratory comparisons.