ICH Topic Q5B Quality Biotechnological Products Analysis Expression Construct Cell Lines Used Production R DNA Derived Protein Products
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/ich-topic-q5b-quality-biotechnological-products-analysis-expression-construct-cell-lines-used-production-r-dna-derived-protein-products
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