Module 9 2021

19/03/2021

Use of Novel Molecular Methods for Virus Detection

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Regulations are moving at a slower rate than novel molecular technologies for virus detection; Agencies require testing according to Regulatory Guidelines ● Methods are not yet ready for Prime Time testing (routine testing) ● Methods can be used for contamination incidents such as ‘fermentor fire’ i.e. use of MP Seq in conjunction with orthoganol virus detection methods such as electron microscopy ● Methods can be used for characterization of novel cell substrates ● Nucleic acid methods are used in the Blood Industry ● Nucleic acid methods for Mice Minute Virus Regulatory Agencies are working with Industry on the application of novel methods i.e. FDA/PDA ● PDA Technical Report 71 Emerging Methods for Virus Detection (2015) – Degenerate and Consensus PCR Assays – Broad-Range PCR with Electrospray Ionization Mass Spectrometry (PCR/ESI-MS) – Massively Parallel Sequencing – Broad-Spectrum Microbial Detection Microarrays

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CHO Endogenous Retroviruses

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Chinese Hamster

CHO cell

RVLP

Monoclonal Antibody Production

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