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The CDMO I work for is adding a microbial manufacturing line (previously my site was only mammalian CHO) and I've been given the task of writing an SOP for our QC group to perform plasmid retention tests.
I've done this in grad school but never under a GMP umbrella. Can anyone point me to a good resource I can use to build the method with that will bear weight under regulatory scrutiny (we are a US based site but do conform to EU and Chinese regulatory bodies). I have a google translated method from a sister site in Germany but I'd like to make sure I'm creating a solid document.
Thanks for any help you can offer.
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