Ensuring the consistency of rDNA-derived biologicals: the contribution of gene sequencing.

Abstract excerpt

The past few years have seen an interesting debate on the extent to which DNA-sequencing of expression systems is appropriate as a basis for assessing the quality and consistency of rDNA-derived products. While there is a need to improve and validate the ability of end-product testing procedures to detect low levels of variant proteins, there are several reasons why it may not be justified to require extensive...

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