A review of molecular biology based rapid methods for the detection and/or identification of Viruses
This paper is required as part of a Module in Biocontamination Monitoring and Control as part of a MSc. In Biopharmaceutical Science. It is worth 50% of the entire module.
- NB not to exceed word count of 5’000 (excluding references)
- NB for strong discussion in emerging technologies for rapid detection of Viruses using Molecular methods.
- NB to use Harvard style Referencing
- Use of diagrams to explain techniques encouraged
- If figures/diagrams are used must stand alone with title and legend
- NB to use relevant sources (articles published within the last ~5 years)
Abstract (10%)
I have written a brief to follow for the paper, but this is open to readjustment as the paper develops and may be edited in the final draft.
‘Viruses are adventitious agents that may be inadvertently introduced into a biopharmaceutical manufacturing process. Testing for the presence of viruses is performed as part of raw materials testing, cell-line characterization and lot release testing of biologics. Detection of viral contamination has previously been performed using the presence of viral particles in TEM and flow cytometry, cell culture and immune-fluorescence assays. These techniques have been used successfully and are examined extensively in the literature. Here, current molecular based methods are reviewed, with focus on rapid detection methods. The basis of these molecular assays is the detection of viral DNA, RNA or particles and they are best described as three subcategories; assays which use Southern Blotting or Southern Transfer Hybridization (STH), Dot Blot Hybridization (DB) and In Situ Hybridization (ISH), those based on a signal amplified hybridization such as hybrid-capture assays, and assays which are target amplification assays, for example PCR and situ PCR. Each category has been discussed based on the mode of action of these methodologies, their successes and limitations. Further to the limitations, an examination of technologies currently under investigation was performed and key promising areas in the future of rapid based molecular detection of viruses discussed.’
Introduction (20%)
May include:
- Viral contamination in the biologics manufacturing industry discussed
- Need for robust detection/identification
- Review of current methods as indicated above
- Limitations of current methods discussed
- Rapid methods; what are they?
Main Body (50%)
- Rapid methods in use
- Examination of current molecular methods under investigation/recently described in the literature for rapid viral detection/identification to highlight advantages and the future of these technologies
- Discuss difficulty of rapid methods with complying with regulation/are they too sensitive pick up on more problems PCR example. Can method of detection get through validation/comply with existing specifications?
Conclusion/Recommendations (20%)
References (~30, mostly consisting of relevant Journal Articles published in the last 5 years)